Drugs Similar to METHYLPHENIDATE HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE

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Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE
18 mg Extended-release
CAMBER PHARMACEUTICALS, INC. FDA Rx Only

Methylphenidate hydrochloride extended-release tablets, USP is a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets are available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d, l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C 14 H 19 NO 2 ·HCl. Its structural formula is: Methylphenidate HCl USP is a white to off-white crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets, USP also contains the following inert ingredients and are common to all strengths: butylated hydroxytoluene, cellulose acetate, hypromellose, phosphoric acid, polyethylene glycol, polyethylene oxides, povidone, propylene glycol, sodium chloride, stearic acid, succinic acid, ferric oxide yellow, FD&C Red No 40 and titanium dioxide. The 18 mg tablet strength also contains iron oxide yellow and Polysorbate 80. The 27 mg tablet strength also contains iron oxide red. The 36 mg tablet strength also contains talc. The 54 mg tablet strength also contains iron oxide yellow, iron oxide red and talc. Each tablet strength also contains black iron oxide, hypromellose and propylene glycol as imprinting ink. USP Dissolution Test Pending. STRUCTURE 11.1 System Components and Performance Methylphenidate hydrochloride extended-release tablets uses osmotic pressure to deliver methylphenidate HCl at a controlled rate. The system, which resembles a conventional tablet in appearance, comprises an osmotically active trilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice on the drug-layer end of the tablet. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core. As the osmotically active polymer excipients expand, methylphenidate is released through the orifice. The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug-concentration gradient incorporated into the two drug layers of methylphenidate hydrochloride extended-release tablets. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that methylphenidate hydrochloride extended-release tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized.

Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE
BRYANT RANCH PREPACK FDA Rx Only

Methylphenidate hydrochloride oral solution is a CNS stimulant available as 5 mg/5 mL and 10 mg/5 mL strengths for oral administration. Chemically, Methylphenidate hydrochloride is ( d,l racemic) methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is: Methylphenidate hydrochloride, USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Each mL of methylphenidate hydrochloride oral solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride, USP. Each mL of methylphenidate hydrochloride oral solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride, USP. In addition, methylphenidate hydrochloride oral solution also contains the following inactive ingredients: artificial grape flavor, glycerin, hydrochloric acid, polyethylene glycol 1450, and purified water.

METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE
ACCORD HEALTHCARE, INC. FDA Rx Only

Methylphenidate hydrochloride tablets, USP contains methylphenidate hydrochloride, a CNS stimulant. It is available as tablets of 5 mg, 10 mg, and 20 mg strengths for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is: Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride tablets, USP contains the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, and microcrystalline cellulose. Methylphenidate hydrochloride structural formula.

METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE
BRYANT RANCH PREPACK FDA Rx Only

Methylphenidate hydrochloride tablets contain methylphenidate hydrochloride, a CNS stimulant. It is available as tablets of 5 mg, 10 mg, and 20 mg strengths for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is: Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride tablets contain the following inactive ingredients: lactose monohydrate, silicified microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate and D&C Yellow #10 (5 mg and 20 mg tablets).

Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE
XLCARE PHARMACEUTICALS, INC. FDA Rx Only

Methylphenidate hydrochloride chewable tablets are a mild central nervous system (CNS) stimulant, available as 2.5 mg, 5 mg and 10 mg for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is Methylphenidate Hydrochloride C 14 H 19 NO 2 • HCl MW = 269.77 Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Each methylphenidate hydrochloride chewable tablet, for oral administration, contains 2.5 mg, 5 mg or 10 mg of methylphenidate hydrochloride USP. In addition, methylphenidate hydrochloride chewable tablets also contain the following inactive ingredients: aspartame, lactose anhydrous, microcrystalline cellulose, guar gum, grape flavor, pregelatinized starch, and stearic acid. structure

Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE
18 mg Extended-release
AVPAK FDA Rx Only

Methylphenidate hydrochloride extended-release tablets, USP is a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets are available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d, l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C 14 H 19 NO 2 ·HCl. Its structural formula is: Methylphenidate HCl USP is a white to off-white crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets, USP also contains the following inert ingredients and are common to all strengths: butylated hydroxytoluene, cellulose acetate, hypromellose, phosphoric acid, polyethylene glycol, polyethylene oxides, povidone, propylene glycol, sodium chloride, stearic acid, succinic acid, ferric oxide yellow, FD&C Red No 40 and titanium dioxide. The 18 mg tablet strength also contains iron oxide yellow and Polysorbate 80. The 27 mg tablet strength also contains iron oxide red. The 36 mg tablet strength also contains talc. The 54 mg tablet strength also contains iron oxide yellow, iron oxide red and talc. Each tablet strength also contains black iron oxide, hypromellose and propylene glycol as imprinting ink. USP Dissolution Test Pending. Structure 11.1 System Components and Performance Methylphenidate hydrochloride extended-release tablets uses osmotic pressure to deliver methylphenidate HCl at a controlled rate. The system, which resembles a conventional tablet in appearance, comprises an osmotically active trilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice on the drug-layer end of the tablet. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core. As the osmotically active polymer excipients expand, methylphenidate is released through the orifice. The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug-concentration gradient incorporated into the two drug layers of methylphenidate hydrochloride extended-release tablets. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that methylphenidate hydrochloride extended-release tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized.

METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE
CAMBER PHARMACEUTICAL INC FDA Rx Only

Methylphenidate hydrochloride tablets, USP is a CNS stimulant. It is available as tablets of 5 mg, 10 mg, and 20 mg strength for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is: Methylphenidate hydrochloride USP is a white to off white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride tablets, USP contain the following inactive ingredients: compressible sugar, colloidal silicon dioxide, D&C yellow no. 10 (5 mg and 20 mg tablets), lactose monohydrate, magnesium stearate, and microcrystalline cellulose. image description

Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE
CAMBER PHARMACEUTICALS INC. FDA Rx Only

Methylphenidate hydrochloride chewable tablets are a mild central nervous system (CNS) stimulant, available as 2.5 mg, 5 mg and 10 mg for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is Methylphenidate Hydrochloride C 14 H 19 NO 2 • HCl MW = 269.77 Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Each methylphenidate hydrochloride chewable tablet, for oral administration, contains 2.5 mg, 5 mg or 10 mg of methylphenidate hydrochloride USP. In addition, methylphenidate hydrochloride chewable tablets also contain the following inactive ingredients: aspartame, lactose anhydrous, microcrystalline cellulose, guar gum, grape flavor, pregelatinized starch, and stearic acid. structure

Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE
BRYANT RANCH PREPACK FDA Rx Only

Methylphenidate hydrochloride oral solution contains methylphenidate hydrochloride a CNS stimulant. It is available as an oral solution in 5 mg/5 mL and 10 mg/5 mL strengths for oral administration. Chemically, methylphenidate hydrochloride is ( d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride and its structural formula is: Methylphenidate hydrochloride USP is a white to off white, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Each mL of methylphenidate hydrochloride oral solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride USP. Each mL of methylphenidate hydrochloride oral solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride USP. Methylphenidate hydrochloride oral solution also contains the following inactive ingredients: glycerin, polyethylene glycol 1450, concord grape flavor N&A, diluted hydrochloric acid (10%), and purified water.

Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE
BRYANT RANCH PREPACK FDA Rx Only

Methylphenidate hydrochloride oral solution is a mild central nervous system (CNS) stimulant available as 5 mg/5 mL and 10 mg/5 mL oral solutions for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is Methylphenidate hydrochloride USP is a white to off white, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Each mL of methylphenidate hydrochloride oral solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride USP. Each mL of methylphenidate hydrochloride oral solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride USP. In addition, methylphenidate hydrochloride oral solution also contains the following inactive ingredients: glycerin,polyethylene glycol 1450, concord grape flavor N&A, diluted hydrochloric acid (10%), and purified water.

Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE
BRYANT RANCH PREPACK FDA Rx Only

Methylphenidate HCl is a mild central nervous system (CNS) stimulant, available as 2.5 mg, 5 mg and 10 mg chewable tablets for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is Methylphenidate Hydrochloride C 14 H 19 NO 2 • HCl MW = 269.77 Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Each methylphenidate hydrochloride chewable tablet, for oral administration, contains 2.5 mg, 5 mg or 10 mg of methylphenidate hydrochloride USP. In addition, methylphenidate hydrochloride chewable tablets also contain the following inactive ingredients: aspartame, lactose anhydrous, microcrystalline cellulose, guar gum, grape flavor, pregelatinized starch, and stearic acid.

Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE
18 mg Extended-release
BRYANT RANCH PREPACK FDA Rx Only

Methylphenidate HCl Extended-Release Tablets, USP are a central nervous system (CNS) stimulant. Methylphenidate HCl Extended-Release Tablets, USP are available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C 14 H 19 NO 2 •HCl. Its structural formula is: Methylphenidate HCl USP is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate HCl Extended-Release Tablets, USP also contains the following inert ingredients: carboxymethylcellulose sodium, colloidal silicon dioxide, corn starch, ethocel, hydroxypropyl cellulose, hypromellose, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sucrose, talc, titanium dioxide and triethyl citrate. The 18, 36, and 54 mg tablets also contain synthetic red iron oxide. The 27 mg tablets also contain yellow iron oxide. Methylphenidate HCl Extended-Release Tablets meet USP Dissolution Test 3. 11.1 System Components and Performance Methylphenidate HCl Extended-Release Tablets uses extended-release bead technology to deliver methylphenidate HCl at a controlled rate. The system, which resembles a conventional tablet in appearance, is comprised of a tablet core containing the extended-release beads and the core is covered with an immediate-release drug overcoat. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. The tablet disintegrates and then polymer coatings on the beads control the release of methylphenidate HCl over the 12 hour dosing period.

METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE
BRYANT RANCH PREPACK FDA Rx Only

Methylphenidate hydrochloride tablets contain methylphenidate hydrochloride, a CNS stimulant. It is available as tablets of 5 mg, 10 mg, and 20 mg strengths for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is: Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride tablets contain the following inactive ingredients: lactose monohydrate, silicified microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate and D&C Yellow #10 (5 mg and 20 mg tablets).

METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE
10 mg Extended-release
GRANULES PHARMACEUTICALS INC. FDA Rx Only

Methylphenidate hydrochloride extended-release tablets, USP contains methylphenidate hydrochloride a CNS stimulant. It is available as extended-release tablets of 10 mg and 20 mg strength for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is: Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride extended-release tablets, USP contains the following inactive ingredients: hypromellose, microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide and magnesium stearate. FDA approved dissolution test differs from the USP dissolution test. methyl-ER-tabs-str

Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE
BRYANT RANCH PREPACK FDA Rx Only

Methylphenidate hydrochloride oral solution contains methylphenidate hydrochloride a CNS stimulant. It is available as an oral solution in 5 mg/5 mL and 10 mg/5 mL strengths for oral administration. Chemically, methylphenidate hydrochloride is ( d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride and its structural formula is: Methylphenidate hydrochloride USP is a white to off white, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Each mL of methylphenidate hydrochloride oral solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride USP. Each mL of methylphenidate hydrochloride oral solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride USP. Methylphenidate hydrochloride oral solution also contains the following inactive ingredients: glycerin, polyethylene glycol 1450, concord grape flavor N&A, diluted hydrochloric acid (10%), and purified water.

Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE
ASCEND LABORATORIES, LLC FDA Rx Only

Methylphenidate hydrochloride tablets USP contains methylphenidate hydrochloride, a CNS stimulant. It is available as tablets of 5mg, 10mg, and 20 mg strength for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is: Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride tablets USP contains the following inactive ingredients: Colloidal Silicon Dioxide, D&C Yellow #10 Aluminium lake, FD&C Blue #1/Brilliant Blue FCF Aluminium lake (10-mg tablets), Lactose Monohydrate, Magnesium Stearate, Polyethylene glycol, Pregelatinized starch (5-mg and 20-mg tablets), Sucrose. Methylphenidate-structure

Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE
18 mg Extended-release
DR.REDDYS LABORATORIES INC FDA Rx Only

Methylphenidate hydrochloride extended-release tablet is a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets are available in four strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C 14 H 19 NO 2 •HCl. Its structural formula is: Methylphenidate HCl, USP is a white to off-white fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets also contains the following inert ingredients: butylated hydroxytoluene, cellulose acetate, colloidal silicon dioxide, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, phosphoric acid, poloxamer, polyethylene oxide, povidone, sodium chloride, stearic acid, succinic acid. In addition 18 mg contains Opadry Purple (FD&C Blue #2/Indigo Carmine Aluminum Lake, FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 27 mg contains Opadry Pink (D&C Red #27/Phloxine Aluminum Lake, FD&C Blue #2/Indigo Carmine Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 36 mg contains Opadry Orange (FD&C Red #40/Allura Red AC Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 54 mg contains Opadry Blue (FD&C Blue #2/Indigo Carmine Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide). Opacode Black contains black iron oxide, hypromellose 6 mPas, propylene glycol. "Meets USP Dissolution Test 12" 11.1 System Components and Performance Methylphenidate hydrochloride extended-release tablets uses osmotic pressure to deliver methylphenidate HCl at a controlled rate. The system, which resembles a conventional tablet in appearance, comprises an osmotically active trilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice on the drug-layer end of the tablet. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core. As the osmotically active polymer excipients expand, methylphenidate is released through the orifice. The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug-concentration gradient incorporated into the two drug layers of methylphenidate hydrochloride extended-release tablets. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that methylphenidate hydrochloride extended-release tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized. “FDA approved dissolution test specifications differ from USP”.

METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE
10 mg Extended-release
GOLDEN STATE MEDICAL SUPPLY, INC. FDA Rx Only

Methylphenidate hydrochloride extended-release tablets, USP contains methylphenidate hydrochloride a CNS stimulant. It is available as extended-release tablets of 10 mg and 20 mg strength for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is: Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride extended-release tablets, USP contains the following inactive ingredients: hypromellose, microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide and magnesium stearate. FDA approved dissolution test differs from the USP dissolution test. methyl-ER-tabs-str

Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE
18 mg Extended-release
ACTAVIS PHARMA, INC. FDA Rx Only

Methylphenidate hydrochloride extended-release tablets, USP are a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets, USP are available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18 mg, 27 mg, 36 mg, or 54 mg of methylphenidate hydrochloride, USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate hydrochloride, USP is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C 14 H 19 NO 2 •HCl. Its structural formula is: Methylphenidate hydrochloride, USP is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets, USP also contain the following inert ingredients: colloidal silicon dioxide, fumaric acid, hypromellose 2208, hypromellose 2910, lactose monohydrate, magnesium stearate, methacrylic acid copolymer Type A, methacrylic acid copolymer Type B, talc, titanium dioxide, and triethyl citrate. The 18 mg strength also contains iron oxide red, iron oxide yellow, polyethylene glycol 3350, and polyvinyl alcohol. The 27 mg strength also contains FD&C Blue #2/Indigo Carmine Aluminum Lake, iron oxide black, iron oxide yellow, polyethylene glycol 3350, and polyvinyl alcohol. The 36 mg strength also contains triacetin. The 54 mg strength also contains iron oxide red, polyethylene glycol 3350, and polyvinyl alcohol. The imprinting ink contains ammonium hydroxide, iron oxide black, propylene glycol, and shellac. Meets USP Dissolution Test 11. Structural Formula 11.1 System Components and Performance Methylphenidate hydrochloride extended-release tablets uses osmotic pressure to deliver methylphenidate HCl at a controlled rate. The system, which resembles a conventional tablet in appearance, comprises an osmotically active trilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice on the drug-layer end of the tablet. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core. As the osmotically active polymer excipients expand, methylphenidate is released through the orifice. The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug-concentration gradient incorporated into the two drug layers of methylphenidate hydrochloride extended-release tablets. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that Methylphenidate hydrochloride extended-release tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized.

Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE
18 mg Extended-release
SUN PHARMACEUTICAL INDUSTRIES, INC. FDA Rx Only

Methylphenidate hydrochloride extended-release tablets, USP are a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets, USP are available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl, USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C 14 H 19 NO 2 •HCl. Its structural formula is: Methylphenidate HCl, USP is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets, USP contain the following inactive ingredients: black iron oxide, cellulose acetate, colloidal silicon dioxide, FD&C Red No. 40, FD&C Blue No. 2, hypromellose, phosphoric acid, poloxamer, polyethylene oxide, povidone, propylene glycol, shellac, sodium chloride, stearic acid, succinic acid, titanium dioxide, talc, triacetin, yellow iron oxide. The 54 mg extended-release tablets also contain red iron oxide. Structure 11.1 System Components and Performance Methylphenidate hydrochloride extended-release tablets uses osmotic pressure to deliver methylphenidate HCl at a controlled rate. The system, which resembles a conventional tablet in appearance, comprises an osmotically active trilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice on the drug-layer end of the tablet. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core. As the osmotically active polymer excipients expand, methylphenidate is released through the orifice. The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug-concentration gradient incorporated into the two drug layers of methylphenidate hydrochloride extended-release tablets. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that methylphenidate hydrochloride extended-release tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized. FDA approved dissolution test specifications differ from USP.

By Generic Name

Drugs with the same generic name (different brands)

CONCERTA METHYLPHENIDATE HYDROCHLORIDE
#46 (METHYLPHENIDATE...) 18 mg Extended-release
JANSSEN PHARMACEUTICALS, INC. FDA Rx Only

CONCERTA ® is a central nervous system (CNS) stimulant. CONCERTA is available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C 14 H 19 NO 2 ∙HCl. Its structural formula is: Methylphenidate HCl USP is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. CONCERTA also contains the following inert ingredients: butylated hydroxytoluene, carnauba wax, cellulose acetate, hypromellose, lactose, phosphoric acid, poloxamer, polyethylene glycol, polyethylene oxides, povidone, propylene glycol, sodium chloride, stearic acid, succinic acid, synthetic iron oxides, titanium dioxide, and triacetin. Chemical Structure 11.1 System Components and Performance CONCERTA uses osmotic pressure to deliver methylphenidate HCl at a controlled rate. The system, which resembles a conventional tablet in appearance, comprises an osmotically active trilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice on the drug-layer end of the tablet. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core. As the osmotically active polymer excipients expand, methylphenidate is released through the orifice. The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug-concentration gradient incorporated into the two drug layers of CONCERTA. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that CONCERTA extended-release tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized.

Ritalin METHYLPHENIDATE HYDROCHLORIDE
SANDOZ INC FDA Rx Only

Ritalin contains methylphenidate hydrochloride, a CNS stimulant. It is available as tablets of 5 mg, 10 mg, and 20 mg strengths for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is: Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Ritalin tablets contains the following inactive ingredients: D&C Yellow No. 10 (5-mg and 20-mg tablets), FD&C Green No. 3 (10-mg tablets), lactose, magnesium stearate, polyethylene glycol, starch (5-mg and 10-mg tablets), sucrose, talc, and tragacanth (20-mg tablets). Methylphenidate hydrochloride structural formula.

Ritalin METHYLPHENIDATE HYDROCHLORIDE
NOVARTIS PHARMACEUTICALS CORPORATION FDA Rx Only

Ritalin contains methylphenidate hydrochloride, a CNS stimulant. It is available as tablets of 5 mg, 10 mg, and 20 mg strengths for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is: Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Ritalin tablets contains the following inactive ingredients: D&C Yellow No. 10 (5-mg and 20-mg tablets), FD&C Green No. 3 (10-mg tablets), lactose, magnesium stearate, polyethylene glycol, starch (5-mg and 10-mg tablets), sucrose, talc, and tragacanth (20-mg tablets). Methylphenidate hydrochloride structural formula.

APTENSIO XR METHYLPHENIDATE HYDROCHLORIDE
RHODES PHARMACEUTICALS L.P. FDA Rx Only

APTENSIO XR contains methylphenidate hydrochloride, a central nervous system (CNS) stimulant. APTENSIO XR capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. APTENSIO XR is available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C 14 H 19 NO 2 ∙HCl. Its structural formula is: Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 10 mg: FD&C Blue No. 1 15 mg: D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40 20 mg: D&C Red No. 33, D&C Yellow No. 10 30 mg: FD&C Blue No. 1, FD&C Red No. 3 40 mg: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40 50 mg: D&C Yellow No. 10, FD&C Green No. 3 60 mg: Black Iron Oxide Chemical Structure

JORNAY PM Extended-Release METHYLPHENIDATE HYDROCHLORIDE
IRONSHORE PHARMACEUTICALS INC. FDA Rx Only

JORNAY PM contains methylphenidate hydrochloride, a central nervous system (CNS) stimulant. Methylphenidate hydrochloride is a white, odorless crystalline powder. Its aqueous solutions are acidic. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. The chemical name of methylphenidate hydrochloride is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C 14 H 19 NO 2 •HCl and the molecular weight is 269.77. Its structural formula is The molecular formula of the free base is C 14 H 19 NO 2 and its molecular weight is 233.31. JORNAY PM extended-release capsules contain beads with two functional film coatings (outer delayed-release and inner extended-release) surrounding a drug core coated with methylphenidate hydrochloride. The outer, delayed-release coating delays the initial release of methylphenidate while the inner extended-release coating controls the release throughout the day. JORNAY PM is available as extended-release capsules for oral use in five strengths. Each capsule contains 20 mg, 40 mg, 60 mg, 80 mg, or 100 mg of methylphenidate hydrochloride, which is equivalent to 17.4 mg, 34.8 mg, 52.2 mg, 69.6 mg, or 87.0 mg of methylphenidate free base, respectively. JORNAY PM capsules also contain the following inactive ingredients: dibutyl sebacate, diglycerides, ethylcellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer Type B, microcrystalline cellulose, monoglycerides, polysorbate 80, and talc. The capsule shell of 20 and 40 mg strength capsules is made of FD&C Blue #1, hypromellose, titanium dioxide, yellow iron oxide, and black ink for the imprint. The capsule shell of 60 and 80 mg strength capsules is made of FD&C Blue #1, hypromellose, titanium dioxide, and black ink for the imprint. The capsule shell of 100 mg strength capsule is made of black iron oxide, FD&C Blue #1, hypromellose, red iron oxide, titanium dioxide, and black ink, and white ink for the imprint. Structural Formula

METADATE CD METHYLPHENIDATE HYDROCHLORIDE
AYTU BIOPHARMA, INC. FDA Rx Only

METADATE CD contains methylphenidate hydrochloride, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. METADATE CD is available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride for oral administration. Chemically, methylphenidate HCl is d , l (racemic)- threo -methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2•HCl. Its structural formula is: Methylphenidate HCl USP is a white, odorless, crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. METADATE CD also contains the following inactive ingredients: Dibutyl sebacate, ethylcellulose aqueous dispersion, gelatin, hydroxypropylmethylcellulose, polyethylene glycol, povidone, sugar spheres, and titanium dioxide. The individual capsules contain the following color agents: 10 mg capsules: FD&C Blue No. 2, FDA/E172 Yellow Iron Oxide 20 mg capsules: FD&C Blue No. 2 30 mg capsules: FD&C Blue No. 2, FDA/E172 Red Iron Oxide 40 mg capsules: FDA/E172 Yellow Iron Oxide 50 mg capsules: FD&C Blue No. 2, FDA/E172 Red Iron Oxide structural formula

Methylin METHYLPHENIDATE HYDROCHLORIDE
SHIONOGI INC. FDA Rx Only

Methylin contains methylphenidate hydrochloride a CNS stimulant. It is available as an oral solution in 5 mg/5 mL and 10 mg/5 mL strengths for oral administration. Chemically, methylphenidate hydrochloride is ( d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride and its structural formula is: Methylphenidate hydrochloride is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Each mL of Methylin 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride USP. Each mL of Methylin 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride USP. Methylin also contains the following inactive ingredients: citric acid anhydrous, glycerin, N&A grape flavor, PEG 1450, and purified water. Chemical Structure

Methylphenidate METHYLPHENIDATE HYDROCHLORIDE
KVK-TECH, INC. FDA Rx Only

Methylphenidate hydrochloride oral solution contains methylphenidate hydrochloride a CNS stimulant. It is available as 5 mg/5 mL and 10 mg/5 mL strengths for oral administration. Chemically, methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is: Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Each mL of methylphenidate hydrochloride oral solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride USP. Each mL of methylphenidate hydrochloride oral solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride USP. Methylphenidate hydrochloride oral solution also contains the following inactive ingredients: artificial grape flavor, glycerin, hydrochloric acid, maltitol syrup, propylene glycol, purified water, sodium hydroxide, and sorbitol. Hydrochloric acid may be added to adjust pH. figure01chemicalstructure

Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE
BRYANT RANCH PREPACK FDA Rx Only

Methylphenidate hydrochloride oral solution is a mild central nervous system (CNS) stimulant available as 5 mg/5 mL and 10 mg/5 mL oral solutions for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is Methylphenidate hydrochloride USP is a white to off white, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Each mL of methylphenidate hydrochloride oral solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride USP. Each mL of methylphenidate hydrochloride oral solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride USP. In addition, methylphenidate hydrochloride oral solution also contains the following inactive ingredients: glycerin,polyethylene glycol 1450, concord grape flavor N&A, diluted hydrochloric acid (10%), and purified water.

Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE
18 mg Extended-release
TRIGEN LABORATORIES, LLC FDA Rx Only

Methylphenidate hydrochloride extended-release tablets, USP are a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets, USP are available in five tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, 54, or 72 mg of methylphenidate HCl USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C 14 H 19 NO 2 •HCl. Its structural formula is: Methylphenidate HCl USP is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets, USP also contain the following inactive ingredients: black iron oxide, cellulose acetate, colloidal silicon dioxide, ferrosoferric oxide, hypromellose, lactose monohydrate, magnesium stearate, phosphoric acid, polyethylene glycol, polyethylene oxide, sodium chloride, succinic acid, titanium dioxide, triacetin. In addition, 18 mg tablets contain: iron oxide red, iron oxide yellow 27 mg tablets contain: FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake 54 mg tablets contain: FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake 72 mg tablets contain: FD&C Blue #1 Aluminum Lake FDA approved dissolution test specifications differ from USP structural formula 11.1 System Components and Performance Methylphenidate hydrochloride extended-release tablets use osmotic pressure to deliver methylphenidate HCl at a controlled rate. The system, which resembles a conventional tablet in appearance, comprises an osmotically active bilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The bilayer core is composed of a drug layer containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice on the drug-layer end of the tablet. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core. As the osmotically active polymer excipients expand, methylphenidate is released through the orifice. The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug-concentration gradient incorporated into the drug layer of core of methylphenidate hydrochloride extended-release tablets. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that methylphenidate hydrochloride extended-release tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized.

METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE
10 mg Extended-release
GRANULES PHARMACEUTICALS INC. FDA Rx Only

Methylphenidate hydrochloride extended-release tablets, USP contains methylphenidate hydrochloride a CNS stimulant. It is available as extended-release tablets of 10 mg and 20 mg strength for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is: Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride extended-release tablets, USP contains the following inactive ingredients: hypromellose, microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide and magnesium stearate. FDA approved dissolution test differs from the USP dissolution test. methyl-ER-tabs-str

Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE
18 mg Extended-release
DR.REDDYS LABORATORIES INC FDA Rx Only

Methylphenidate hydrochloride extended-release tablet is a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets are available in four strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C 14 H 19 NO 2 •HCl. Its structural formula is: Methylphenidate HCl, USP is a white to off-white fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets also contains the following inert ingredients: butylated hydroxytoluene, cellulose acetate, colloidal silicon dioxide, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, phosphoric acid, poloxamer, polyethylene oxide, povidone, sodium chloride, stearic acid, succinic acid. In addition 18 mg contains Opadry Purple (FD&C Blue #2/Indigo Carmine Aluminum Lake, FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 27 mg contains Opadry Pink (D&C Red #27/Phloxine Aluminum Lake, FD&C Blue #2/Indigo Carmine Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 36 mg contains Opadry Orange (FD&C Red #40/Allura Red AC Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 54 mg contains Opadry Blue (FD&C Blue #2/Indigo Carmine Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide). Opacode Black contains black iron oxide, hypromellose 6 mPas, propylene glycol. "Meets USP Dissolution Test 12" 11.1 System Components and Performance Methylphenidate hydrochloride extended-release tablets uses osmotic pressure to deliver methylphenidate HCl at a controlled rate. The system, which resembles a conventional tablet in appearance, comprises an osmotically active trilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice on the drug-layer end of the tablet. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core. As the osmotically active polymer excipients expand, methylphenidate is released through the orifice. The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug-concentration gradient incorporated into the two drug layers of methylphenidate hydrochloride extended-release tablets. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that methylphenidate hydrochloride extended-release tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized. “FDA approved dissolution test specifications differ from USP”.

METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE
10 mg Extended-release
GOLDEN STATE MEDICAL SUPPLY, INC. FDA Rx Only

Methylphenidate hydrochloride extended-release tablets, USP contains methylphenidate hydrochloride a CNS stimulant. It is available as extended-release tablets of 10 mg and 20 mg strength for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is: Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride extended-release tablets, USP contains the following inactive ingredients: hypromellose, microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide and magnesium stearate. FDA approved dissolution test differs from the USP dissolution test. methyl-ER-tabs-str

METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE
BRYANT RANCH PREPACK FDA Rx Only

Methylphenidate hydrochloride tablets contain methylphenidate hydrochloride, a CNS stimulant. It is available as tablets of 5 mg, 10 mg, and 20 mg strengths for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is: Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride tablets contain the following inactive ingredients: lactose monohydrate, silicified microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate and D&C Yellow #10 (5 mg and 20 mg tablets).

Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE
10 mg Extended-release
RHODES PHARMACEUTICALS FDA Rx Only

Methylphenidate hydrochloride extended-release capsules contain methylphenidate hydrochloride, a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. Methylphenidate hydrochloride extended-release capsules are available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C 14 H 19 NO 2 ∙HCl. Its structural formula is: Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 10 mg: FD&C Blue No. 1 15 mg: D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40 20 mg: D&C Red No. 33, D&C Yellow No. 10 30 mg: FD&C Blue No. 1, FD&C Red No. 3 40 mg: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40 50 mg: D&C Yellow No. 10, FD&C Green No. 3 60 mg: Black Iron Oxide Chemical Structure

Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE
LUPIN PHARMACEUTICALS,INC. FDA Rx Only

Methylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available as 2.5 mg, 5 mg and 10 mg chewable tablets for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is Methylphenidate hydrochloride USP is a white to off-white powder. Its solutions are acid to litmus. It is soluble in water, alcohol, and chloroform. Each methylphenidate hydrochloride chewable tablet, for oral administration, contains 2.5 mg, 5 mg or 10 mg of methylphenidate hydrochloride USP. In addition, methylphenidate hydrochloride chewable tablets also contain the following inactive ingredients: aspartame, maltose, microcrystalline cellulose, grape flavor, pregelatinized starch, phosphoric acid, and stearic acid. Chemical Structure

Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE
18 mg Extended-release
AVPAK FDA Rx Only

Methylphenidate hydrochloride extended-release tablets, USP is a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets are available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d, l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C 14 H 19 NO 2 ·HCl. Its structural formula is: Methylphenidate HCl USP is a white to off-white crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets, USP also contains the following inert ingredients and are common to all strengths: butylated hydroxytoluene, cellulose acetate, hypromellose, phosphoric acid, polyethylene glycol, polyethylene oxides, povidone, propylene glycol, sodium chloride, stearic acid, succinic acid, ferric oxide yellow, FD&C Red No 40 and titanium dioxide. The 18 mg tablet strength also contains iron oxide yellow and Polysorbate 80. The 27 mg tablet strength also contains iron oxide red. The 36 mg tablet strength also contains talc. The 54 mg tablet strength also contains iron oxide yellow, iron oxide red and talc. Each tablet strength also contains black iron oxide, hypromellose and propylene glycol as imprinting ink. USP Dissolution Test Pending. Structure 11.1 System Components and Performance Methylphenidate hydrochloride extended-release tablets uses osmotic pressure to deliver methylphenidate HCl at a controlled rate. The system, which resembles a conventional tablet in appearance, comprises an osmotically active trilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice on the drug-layer end of the tablet. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core. As the osmotically active polymer excipients expand, methylphenidate is released through the orifice. The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug-concentration gradient incorporated into the two drug layers of methylphenidate hydrochloride extended-release tablets. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that methylphenidate hydrochloride extended-release tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized.

Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE
18 mg Extended-release
TRIGEN LABORATORIES, LLC FDA Rx Only

Methylphenidate hydrochloride extended-release tablets contain methylphenidate a CNS stimulant, present as methylphenidate hydrochloride salt. Chemically, methylphenidate hydrochloride is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C 14 H 19 NO 2 •HCl. Its structural formula is: Methylphenidate hydrochloride is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. It has a pKa of 8.71 (at 21.5°C). Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets are for oral administration and is available in the following strengths: 18 mg, 27 mg, 36 mg, 45 mg, 54 mg, 63 mg, and 72 mg containing methylphenidate hydrochloride (equivalent to 15.6 mg, 23.4 mg, 31.1 mg, 38.9 mg, 46.7 mg, 54.5 mg, and 62.3 mg methylphenidate respectively). Methylphenidate hydrochloride extended-release tablets contain the following inactive ingredients: cellulose acetate, colloidal silicon dioxide, ferrosoferric oxide, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, phosphoric acid, polyethylene glycol, polyethylene oxide, sodium chloride, succinic acid, titanium dioxide, triacetin. Methylphenidate hydrochloride extended-release tablets also contain the following color additives: 27 mg: FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake 45 mg: FD&C Red #40 Aluminum Lake 54 mg: FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake 18 and 63 mg: iron oxide red, iron oxide yellow 72 mg: FD&C Blue #1 Aluminum Lake System Components and Performance Methylphenidate hydrochloride extended-release tablets use osmotic pressure to deliver methylphenidate hydrochloride at a controlled rate. The system, which resembles a conventional tablet in appearance, comprises an osmotically active bilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The bilayer core is composed of a drug layer containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice on the drug-layer end of the tablet. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core. As the osmotically active polymer excipients expand, methylphenidate is released through the orifice. The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug-concentration gradient incorporated into the two drug layers of core of methylphenidate hydrochloride extended-release tablets. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that methylphenidate hydrochloride extended-release tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized. Structural Image

METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE
BRYANT RANCH PREPACK FDA Rx Only

Methylphenidate hydrochloride tablets, USP contains methylphenidate hydrochloride USP, a CNS stimulant. It is available as tablets of 5 mg, 10 mg and 20 mg strengths for oral administration. Methylphenidate hydrochloride, USP is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is: Methylphenidate hydrochloride, USP is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride tablets, USP contain the following inactive ingredients: Lactose monohydrate, microcrystalline cellulose, stearic acid and FD&C Yellow No. 6 Aluminum Lake.

METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE
XLCARE PHARMACEUTICALS INC FDA Rx Only

Methylphenidate hydrochloride tablets, USP is a CNS stimulant. It is available as tablets of 5 mg, 10 mg, and 20 mg strength for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is: Methylphenidate hydrochloride USP is a white to off white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride tablets, USP contain the following inactive ingredients: compressible sugar, colloidal silicon dioxide, D&C yellow no. 10 (5 mg and 20 mg tablets), lactose monohydrate, magnesium stearate, and microcrystalline cellulose. image description

By Substance

Drugs sharing the same substance name

CONCERTA METHYLPHENIDATE HYDROCHLORIDE
#46 (METHYLPHENIDATE...) 18 mg Extended-release
JANSSEN PHARMACEUTICALS, INC. FDA Rx Only

CONCERTA ® is a central nervous system (CNS) stimulant. CONCERTA is available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C 14 H 19 NO 2 ∙HCl. Its structural formula is: Methylphenidate HCl USP is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. CONCERTA also contains the following inert ingredients: butylated hydroxytoluene, carnauba wax, cellulose acetate, hypromellose, lactose, phosphoric acid, poloxamer, polyethylene glycol, polyethylene oxides, povidone, propylene glycol, sodium chloride, stearic acid, succinic acid, synthetic iron oxides, titanium dioxide, and triacetin. Chemical Structure 11.1 System Components and Performance CONCERTA uses osmotic pressure to deliver methylphenidate HCl at a controlled rate. The system, which resembles a conventional tablet in appearance, comprises an osmotically active trilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice on the drug-layer end of the tablet. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core. As the osmotically active polymer excipients expand, methylphenidate is released through the orifice. The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug-concentration gradient incorporated into the two drug layers of CONCERTA. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that CONCERTA extended-release tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized.

Methylphenidate METHYLPHENIDATE
#46 10 mg Extended-release
SANDOZ INC FDA Rx Only

Methylphenidate hydrochloride extended-release capsules are CNS stimulant. Methylphenidate hydrochloride extended-release capsules is an extended-release formulation of methylphenidate for oral administration with a bi-modal release profile. Each bead-filled methylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated beads, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate. The active substance in methylphenidate hydrochloride extended-release capsules is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: ammonio methacrylate copolymer, black iron oxide (10 and 40 mg capsules only), gelatin, methacrylic acid copolymer, polyethylene glycol, red iron oxide (10 and 40 mg capsules only), sugar spheres, talc, titanium dioxide, triethyl citrate, and yellow iron oxide (10, 30, and 40 mg capsules only). Ritalin LA structural formula.

Methylphenidate METHYLPHENIDATE
#46 10 mg Extended-release
SANDOZ INC FDA Rx Only

Methylphenidate hydrochloride extended-release capsules are CNS stimulant. Methylphenidate hydrochloride extended-release capsules is an extended-release formulation of methylphenidate for oral administration with a bi-modal release profile. Each bead-filled methylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated beads, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate. The active substance in methylphenidate hydrochloride extended-release capsules is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: ammonio methacrylate copolymer, black iron oxide (10 and 40 mg capsules only), gelatin, methacrylic acid copolymer, polyethylene glycol, red iron oxide (10 and 40 mg capsules only), sugar spheres, talc, titanium dioxide, triethyl citrate, and yellow iron oxide (10, 30, and 40 mg capsules only). Ritalin LA structural formula.

Ritalin METHYLPHENIDATE HYDROCHLORIDE
SANDOZ INC FDA Rx Only

Ritalin contains methylphenidate hydrochloride, a CNS stimulant. It is available as tablets of 5 mg, 10 mg, and 20 mg strengths for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is: Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Ritalin tablets contains the following inactive ingredients: D&C Yellow No. 10 (5-mg and 20-mg tablets), FD&C Green No. 3 (10-mg tablets), lactose, magnesium stearate, polyethylene glycol, starch (5-mg and 10-mg tablets), sucrose, talc, and tragacanth (20-mg tablets). Methylphenidate hydrochloride structural formula.

Ritalin METHYLPHENIDATE HYDROCHLORIDE
NOVARTIS PHARMACEUTICALS CORPORATION FDA Rx Only

Ritalin contains methylphenidate hydrochloride, a CNS stimulant. It is available as tablets of 5 mg, 10 mg, and 20 mg strengths for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is: Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Ritalin tablets contains the following inactive ingredients: D&C Yellow No. 10 (5-mg and 20-mg tablets), FD&C Green No. 3 (10-mg tablets), lactose, magnesium stearate, polyethylene glycol, starch (5-mg and 10-mg tablets), sucrose, talc, and tragacanth (20-mg tablets). Methylphenidate hydrochloride structural formula.

APTENSIO XR METHYLPHENIDATE HYDROCHLORIDE
RHODES PHARMACEUTICALS L.P. FDA Rx Only

APTENSIO XR contains methylphenidate hydrochloride, a central nervous system (CNS) stimulant. APTENSIO XR capsules contain multi layered beads, which are composed of an immediate-release layer which contains approximately 40% of the methylphenidate dose, and a controlled release layer which contains approximately 60% of the methylphenidate dose. APTENSIO XR is available in seven capsule strengths. Each extended-release capsule for once-a-day oral administration contains 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, or 60 mg of methylphenidate HCl USP, which is equivalent to 8.6 mg, 13.0 mg, 17.3 mg, 25.9 mg, 34.6 mg, 43.2 mg, or 51.9 mg of methylphenidate free base, respectively. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C 14 H 19 NO 2 ∙HCl. Its structural formula is: Methylphenidate hydrochloride USP is a white to off-white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Inactive Ingredients: ammonio methacrylate copolymer, type B; colloidal silicon dioxide (added if necessary); gelatin; hypromelloses; methacrylic acid copolymer, type C; polyethylene glycol; sugar spheres; talc; titanium oxide; and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows: 10 mg: FD&C Blue No. 1 15 mg: D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40 20 mg: D&C Red No. 33, D&C Yellow No. 10 30 mg: FD&C Blue No. 1, FD&C Red No. 3 40 mg: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40 50 mg: D&C Yellow No. 10, FD&C Green No. 3 60 mg: Black Iron Oxide Chemical Structure

JORNAY PM Extended-Release METHYLPHENIDATE HYDROCHLORIDE
IRONSHORE PHARMACEUTICALS INC. FDA Rx Only

JORNAY PM contains methylphenidate hydrochloride, a central nervous system (CNS) stimulant. Methylphenidate hydrochloride is a white, odorless crystalline powder. Its aqueous solutions are acidic. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. The chemical name of methylphenidate hydrochloride is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C 14 H 19 NO 2 •HCl and the molecular weight is 269.77. Its structural formula is The molecular formula of the free base is C 14 H 19 NO 2 and its molecular weight is 233.31. JORNAY PM extended-release capsules contain beads with two functional film coatings (outer delayed-release and inner extended-release) surrounding a drug core coated with methylphenidate hydrochloride. The outer, delayed-release coating delays the initial release of methylphenidate while the inner extended-release coating controls the release throughout the day. JORNAY PM is available as extended-release capsules for oral use in five strengths. Each capsule contains 20 mg, 40 mg, 60 mg, 80 mg, or 100 mg of methylphenidate hydrochloride, which is equivalent to 17.4 mg, 34.8 mg, 52.2 mg, 69.6 mg, or 87.0 mg of methylphenidate free base, respectively. JORNAY PM capsules also contain the following inactive ingredients: dibutyl sebacate, diglycerides, ethylcellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer Type B, microcrystalline cellulose, monoglycerides, polysorbate 80, and talc. The capsule shell of 20 and 40 mg strength capsules is made of FD&C Blue #1, hypromellose, titanium dioxide, yellow iron oxide, and black ink for the imprint. The capsule shell of 60 and 80 mg strength capsules is made of FD&C Blue #1, hypromellose, titanium dioxide, and black ink for the imprint. The capsule shell of 100 mg strength capsule is made of black iron oxide, FD&C Blue #1, hypromellose, red iron oxide, titanium dioxide, and black ink, and white ink for the imprint. Structural Formula

METADATE CD METHYLPHENIDATE HYDROCHLORIDE
AYTU BIOPHARMA, INC. FDA Rx Only

METADATE CD contains methylphenidate hydrochloride, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. METADATE CD is available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride for oral administration. Chemically, methylphenidate HCl is d , l (racemic)- threo -methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2•HCl. Its structural formula is: Methylphenidate HCl USP is a white, odorless, crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. METADATE CD also contains the following inactive ingredients: Dibutyl sebacate, ethylcellulose aqueous dispersion, gelatin, hydroxypropylmethylcellulose, polyethylene glycol, povidone, sugar spheres, and titanium dioxide. The individual capsules contain the following color agents: 10 mg capsules: FD&C Blue No. 2, FDA/E172 Yellow Iron Oxide 20 mg capsules: FD&C Blue No. 2 30 mg capsules: FD&C Blue No. 2, FDA/E172 Red Iron Oxide 40 mg capsules: FDA/E172 Yellow Iron Oxide 50 mg capsules: FD&C Blue No. 2, FDA/E172 Red Iron Oxide structural formula

Methylin METHYLPHENIDATE HYDROCHLORIDE
SHIONOGI INC. FDA Rx Only

Methylin contains methylphenidate hydrochloride a CNS stimulant. It is available as an oral solution in 5 mg/5 mL and 10 mg/5 mL strengths for oral administration. Chemically, methylphenidate hydrochloride is ( d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride and its structural formula is: Methylphenidate hydrochloride is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Each mL of Methylin 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride USP. Each mL of Methylin 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride USP. Methylin also contains the following inactive ingredients: citric acid anhydrous, glycerin, N&A grape flavor, PEG 1450, and purified water. Chemical Structure

Methylphenidate METHYLPHENIDATE HYDROCHLORIDE
KVK-TECH, INC. FDA Rx Only

Methylphenidate hydrochloride oral solution contains methylphenidate hydrochloride a CNS stimulant. It is available as 5 mg/5 mL and 10 mg/5 mL strengths for oral administration. Chemically, methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is: Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Each mL of methylphenidate hydrochloride oral solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride USP. Each mL of methylphenidate hydrochloride oral solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride USP. Methylphenidate hydrochloride oral solution also contains the following inactive ingredients: artificial grape flavor, glycerin, hydrochloric acid, maltitol syrup, propylene glycol, purified water, sodium hydroxide, and sorbitol. Hydrochloric acid may be added to adjust pH. figure01chemicalstructure

Methylphenidate HCl METHYLPHENIDATE HCL
PATRIN PHARMA, INC. FDA Rx Only

Methylphenidate hcl oral solution is a mild central nervous system (CNS) stimulant available as 5 mg /5 mL and 10 mg /5 mL oral solutions for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Each mL of methylphenidate hcl oral solution 5 mg /5 mL contains 1 mg of methylphenidate hydrochloride USP. Each mL of methylphenidate hcl oral solution 10 mg /5 mL contains 2 mg of methylphenidate hydrochloride USP. In addition, methylphenidate hcl oral solution also contains the following inactive ingredients: phosphoric acid, glycerin, N&A grape flavor, PEG 1450, and purified water.

Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE
ASCEND LABORATORIES, LLC FDA Rx Only

Methylphenidate hydrochloride tablets USP contains methylphenidate hydrochloride, a CNS stimulant. It is available as tablets of 5mg, 10mg, and 20 mg strength for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is: Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride tablets USP contains the following inactive ingredients: Colloidal Silicon Dioxide, D&C Yellow #10 Aluminium lake, FD&C Blue #1/Brilliant Blue FCF Aluminium lake (10-mg tablets), Lactose Monohydrate, Magnesium Stearate, Polyethylene glycol, Pregelatinized starch (5-mg and 20-mg tablets), Sucrose. Methylphenidate-structure

METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE
10 mg Extended-release
GOLDEN STATE MEDICAL SUPPLY, INC. FDA Rx Only

Methylphenidate hydrochloride extended-release tablets, USP contains methylphenidate hydrochloride a CNS stimulant. It is available as extended-release tablets of 10 mg and 20 mg strength for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is: Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride extended-release tablets, USP contains the following inactive ingredients: hypromellose, microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide and magnesium stearate. FDA approved dissolution test differs from the USP dissolution test. methyl-ER-tabs-str

Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE
10 mg Extended-release
SPECGX LLC FDA Rx Only

Methylphenidate hydrochloride extended-release tablets contain methylphenidate hydrochloride, a CNS stimulant. They are available as extended-release tablets of 10 mg and 20 mg strength for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is: Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride extended-release tablets contain the following inactive ingredients: hydroxypropyl methylcellulose 2208, magnesium stearate, microcrystalline cellulose, and talc. Note : Methylphenidate hydrochloride extended-release tablets are color-additive free. Structural Formula

Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE
18 mg Extended-release
ACTAVIS PHARMA, INC. FDA Rx Only

Methylphenidate hydrochloride extended-release tablets, USP are a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets, USP are available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18 mg, 27 mg, 36 mg, or 54 mg of methylphenidate hydrochloride, USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate hydrochloride, USP is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C 14 H 19 NO 2 •HCl. Its structural formula is: Methylphenidate hydrochloride, USP is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets, USP also contain the following inert ingredients: colloidal silicon dioxide, fumaric acid, hypromellose 2208, hypromellose 2910, lactose monohydrate, magnesium stearate, methacrylic acid copolymer Type A, methacrylic acid copolymer Type B, talc, titanium dioxide, and triethyl citrate. The 18 mg strength also contains iron oxide red, iron oxide yellow, polyethylene glycol 3350, and polyvinyl alcohol. The 27 mg strength also contains FD&C Blue #2/Indigo Carmine Aluminum Lake, iron oxide black, iron oxide yellow, polyethylene glycol 3350, and polyvinyl alcohol. The 36 mg strength also contains triacetin. The 54 mg strength also contains iron oxide red, polyethylene glycol 3350, and polyvinyl alcohol. The imprinting ink contains ammonium hydroxide, iron oxide black, propylene glycol, and shellac. Meets USP Dissolution Test 11. Structural Formula 11.1 System Components and Performance Methylphenidate hydrochloride extended-release tablets uses osmotic pressure to deliver methylphenidate HCl at a controlled rate. The system, which resembles a conventional tablet in appearance, comprises an osmotically active trilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice on the drug-layer end of the tablet. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core. As the osmotically active polymer excipients expand, methylphenidate is released through the orifice. The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug-concentration gradient incorporated into the two drug layers of methylphenidate hydrochloride extended-release tablets. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that Methylphenidate hydrochloride extended-release tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized.

Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE
18 mg Extended-release
SUN PHARMACEUTICAL INDUSTRIES, INC. FDA Rx Only

Methylphenidate hydrochloride extended-release tablets, USP are a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets, USP are available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl, USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its molecular formula is C 14 H 19 NO 2 •HCl. Its structural formula is: Methylphenidate HCl, USP is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets, USP contain the following inactive ingredients: black iron oxide, cellulose acetate, colloidal silicon dioxide, FD&C Red No. 40, FD&C Blue No. 2, hypromellose, phosphoric acid, poloxamer, polyethylene oxide, povidone, propylene glycol, shellac, sodium chloride, stearic acid, succinic acid, titanium dioxide, talc, triacetin, yellow iron oxide. The 54 mg extended-release tablets also contain red iron oxide. Structure 11.1 System Components and Performance Methylphenidate hydrochloride extended-release tablets uses osmotic pressure to deliver methylphenidate HCl at a controlled rate. The system, which resembles a conventional tablet in appearance, comprises an osmotically active trilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice on the drug-layer end of the tablet. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core. As the osmotically active polymer excipients expand, methylphenidate is released through the orifice. The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug-concentration gradient incorporated into the two drug layers of methylphenidate hydrochloride extended-release tablets. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that methylphenidate hydrochloride extended-release tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized. FDA approved dissolution test specifications differ from USP.

Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE
AUROLIFE PHARMA, LLC FDA Rx Only

Methylphenidate hydrochloride, USP is a CNS stimulant. It is available as tablets of 5, 10, and 20 mg oral strengths for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is Methylphenidate hydrochloride, USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular formula is C 14 H 19 NO 2 •HCl, and its molecular weight is 269.77 g/mol. Inactive Ingredients. Methylphenidate hydrochloride tablets: Copovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc. Structure

Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE
EYWA PHARMA INC FDA Rx Only

Methylphenidate hydrochloride oral solution contains methylphenidate hydrochloride a CNS stimulant. It is available as an oral solution in 5 mg/5 mL and 10 mg/5 mL strengths for oral administration. Chemically, methylphenidate hydrochloride is ( d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride and its structural formula is: Methylphenidate hydrochloride USP is a white to off white, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Each mL of methylphenidate hydrochloride oral solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride USP. Each mL of methylphenidate hydrochloride oral solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride USP. Methylphenidate hydrochloride oral solution also contains the following inactive ingredients: glycerin, polyethylene glycol 1450, concord grape flavor N&A, diluted hydrochloric acid (10%), and purified water. Structure

Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE
LUPIN PHARMACEUTICALS,INC. FDA Rx Only

Methylphenidate hydrochloride tablets contains methylphenidate hydrochloride, a CNS stimulant. It is available as tablets of 5 mg, 10 mg, and 20 mg strength for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is: Methylphenidate hydrochloride, USP is a white to off-white fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride tablets contains the following inactive ingredients: D&C Yellow No. 10 (5-mg and 20-mg tablets), lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (Potato), magnesium stearate, and talc. Image

Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE
18 mg Extended-release
XLCARE PHARMACEUTICALS, INC. FDA Rx Only

Methylphenidate hydrochloride extended-release tablets, USP is a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets are available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d, l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C 14 H 19 NO 2 ·HCl. Its structural formula is: Methylphenidate HCl USP is a white to off-white crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77. Methylphenidate hydrochloride extended-release tablets, USP also contains the following inert ingredients and are common to all strengths: butylated hydroxytoluene, cellulose acetate, hypromellose, phosphoric acid, polyethylene glycol, polyethylene oxides, povidone, propylene glycol, sodium chloride, stearic acid, succinic acid, ferric oxide yellow, FD&C Red No 40 and titanium dioxide. The 18 mg tablet strength also contains iron oxide yellow and Polysorbate 80. The 27 mg tablet strength also contains iron oxide red. The 36 mg tablet strength also contains talc. The 54 mg tablet strength also contains iron oxide yellow, iron oxide red and talc. Each tablet strength also contains black iron oxide, hypromellose and propylene glycol as imprinting ink. USP Dissolution Test Pending. STRUCTURE 11.1 System Components and Performance Methylphenidate hydrochloride extended-release tablets uses osmotic pressure to deliver methylphenidate HCl at a controlled rate. The system, which resembles a conventional tablet in appearance, comprises an osmotically active trilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice on the drug-layer end of the tablet. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core. As the osmotically active polymer excipients expand, methylphenidate is released through the orifice. The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug-concentration gradient incorporated into the two drug layers of methylphenidate hydrochloride extended-release tablets. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that methylphenidate hydrochloride extended-release tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized.

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