granules pharmaceuticals inc. - Medication Listings

Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N- dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below: Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4 H 11 N 5 • HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients povidone (K-30), Povidone (K-90), pregelatinized starch, and magnesium stearate. In addition, the coating for the tablet contains artificial blackberry flavor, hypromellose, macrogol and titanium dioxide. metformin-structure.jpg.jpg

Metformin hydrochloride extended-release tablet USP contains the biguanide antihyperglycemic agent metformin in the form of monohydrochloride salt. The chemical name of metformin hydrochloride is 1,1-Dimethylbiguanide monohydrochloride. The structural formula is as shown: Metformin hydrochloride USP is a white crystalline powder with a molecular formula of C 4 H 11 N 5 .HCl and a molecular weight of 165.62. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 10% aqueous solution of metformin hydrochloride is 7.45. Metformin hydrochloride extended-release tablets USP contain 500 mg or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg or 779.86 mg metformin, respectively. Each 500 mg and 1000 mg tablet contains ammonio methacrylate copolymer type A, hypromellose, magnesium stearate, povidone, talc, triethyl citrate. Metformin hydrochloride extended-release tablets USP meets USP Dissolution Test 12. metformin-structure-jpg

Metoprolol succinate, is a beta 1 -selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1-(isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is: Metoprolol succinate, USP is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in alcohol; slightly soluble in isopropyl alcohol. Inactive ingredients: acetyl tributyl citrate, carnauba wax, colloidal silicon dioxide, ethylcellulose, glyceryl dibehenate, hydroxypropyl cellulose, hypromellose, Microcrystalline cellulose PH 105, Microcrystalline cellulose PH 102, polyethylene glycol, sodium stearyl fumarate, titanium dioxide. Meets USP dissolution test 13. meto-structure.jpg

Losartan potassium is an angiotensin II receptor blocker acting on the At 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p -( o -1 H- tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C 22 H 22 CIKN 6 O, and its structural formula is: Losartan potassium is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium tablets, USP are available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, opadry white, and pregelatinized starch. Losartan potassium tablets, USP 25 mg, 50 mg and 100 mg contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. Losartan potassium tablets, USP meets USP Dissolution Test 2. losartan-structure-jpg

The active ingredient in gabapentin tablets, USP is gabapentin USP, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9 H 17 NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is: Gabapentin, USP is a white to off-white crystalline powder with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and in alkaline and acidic solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each gabapentin tablet, USP contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: copovidone, crospovidone, hydroxypropyl cellulose, magnesium stearate, maize starch, microcrystalline cellulose and talc. FDA approved dissolution test specifications differ from USP. structure

Gabapentin is described as 1-(aminomethyl) cyclohexaneacetic acid with a molecular formula of C 9 H 17 NO 2 and a molecular weight of 171.24. Gabapentin is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.25. It has the following structural formula: Gabapentin capsules, USP are for oral administration and contain 100 mg, 300 mg and 400 mg of gabapentin. In addition, each capsule contains the following inactive ingredients: croscarmellose sodium and magnesium stearate. The 100 mg, 300 mg and 400 mg capsule imprinting ink contains the following inactive ingredients: black iron oxide E172; butyl alcohol; dehydrated alcohol; isopropyl alcohol; potassium hydroxide; propylene glycol; purified water; shellac E904 and strong ammonia solution. The 100 mg capsule shell contains gelatin and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide and yellow iron oxide. The 400 mg capsule shell contains gelatin, red iron oxide, titanium oxide and yellow iron oxide. gaba-structure.jpg

Gabapentin is described as 1-(aminomethyl) cyclohexaneacetic acid with a molecular formula of C 9 H 17 NO 2 and a molecular weight of 171.24. Gabapentin is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.25. It has the following structural formula: Gabapentin capsules, USP are for oral administration and contain 100 mg, 300 mg and 400 mg of gabapentin, USP. In addition, each capsule contains the following inactive ingredients: Mannitol, maize starch and talc. The 100 mg, 300 mg and 400 mg capsule imprinting ink contain the following inactive ingredients: butyl alcohol, dehydrated alcohol, FD & C blue #1 aluminum lake, isopropyl alcohol, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. The 100 mg capsule shell contains gelatin and titanium dioxide. The 300 mg capsule shell contains gelatin, ferric oxide yellow and titanium dioxide. The 400 mg capsule shell contains gelatin, ferric oxide red, ferric oxide yellow and titanium dioxide. gaba-structure

The active ingredient in pantoprazole sodium delayed-release oral tablets USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1 H -benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its molecular formula is C 16 H 14 F 2 N 3 NaO 4 S x 1.5 H 2 O, with a molecular weight of 432.4. The structural formula is: Pantoprazole sodium sesquihydrate, USP is a white to off-white powder. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, methanol, dehydrated alcohol, practically insoluble in hexane and dichloromethane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium, USP is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.56 mg of pantoprazole sodium, USP) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium, USP). Pantoprazole sodium delayed-release tablets, USP contains the following inactive ingredients: calcium stearate, crospovidone, ferric oxide yellow, hydroxypropyl cellulose, hydroxypropyl methylcellulose, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, sodium carbonate anhydrous and triethyl citrate. In addition, tablet imprinting ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze. Pantoprazole sodium delayed-release tablets meets USP dissolution test 2. panto-dr-structure

Sertraline hydrochloride tablets, USP contains sertraline hydrochloride USP, an SSRI. Sertraline hydrochloride, USP has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17 H 17 NCl 2 ·HCl is represented by the following structural formula. Sertraline hydrochloride, USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration contain 28 mg, 56 mg and 111.9 mg sertraline hydrochloride, USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, low substituted hydroxypropyl cellulose, sodium starch glycolate, talc, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, D & C Yellow #10 aluminum lake (in 25 mg and 100 mg tablet), FD & C Blue #2 aluminum lake (in 25 mg and 50 mg tablet), iron oxide black (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 50 mg tablet) and iron oxide yellow (in 100 mg tablet). Meets USP dissolution test 3. sertraline-structure

Trazodone hydrochloride tablets, USP for oral administration contain trazodone hydrochloride, USP, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride is a triazolopyridine derivative designated as 1,2,4-Triazolo[4,3-a]pyridin-3(2H)-one, 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-, monohydrochloride. It is a white to off white, crystalline powder which is sparingly soluble in chloroform and in water. The structural formula is represented as follows: Molecular Formula: C 19 H 22 CIN 5 O • HCl Molecular Weight: 408.32 Each tablet, for oral administration, contains 50 mg, 100 mg, 150 mg or 300 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinised starch, sodium lauryl sulphate, sodium starch glycolate type A. FDA approved dissolution test specifications differ from USP. trazodone-structure

The active ingredient in esomeprazole magnesium delayed-release capsules, USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C 17 H 18 N 3 O 3 S)2Mg x 3 H 2 O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly cream or slightly yellow colored powder. It contains 3 moles of water of solvation and is slightly soluble in water, soluble in methanol, practically insoluble in heptane. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each esomeprazole magnesium delayed-release capsule contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate USP) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate USP) in the form of enteric-coated granules with the following inactive ingredients: hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, mono- and di-glycerides, polysorbate 80, simethicone emulsion, sugar spheres, talc, and triethyl citrate. Capsule shell contains FD&C Blue #1, gelatin, sodium lauryl sulfate, and titanium dioxide. In addition, capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2. esome-structure

USES • temporarily relieves minor aches and pains due to: • the common cold • headache • backache • minor pain of arthritis • toothache • muscular aches • premenstrual and menstrual cramps • temporarily reduces fever

USES For Arthritis Pain label • temporarily relieves minor aches and pains due to: • minor pain of arthritis • muscular aches • backache • premenstrual and menstrual cramps • the common cold • headache • toothache • temporarily reduces fever For Muscle Aches & Pain label • temporarily relieves minor aches and pains due to: • muscular aches • backache • minor pain of arthritis • toothache • premenstrual and menstrual cramps • headache • the common cold • temporarily reduces fever

Naproxen tablets are nonsteroidal anti-inflammatory drugs available as follows: Naproxen tablets are available as white to off-white tablets containing 250 mg, 375 mg and 500 mg of naproxen for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen and naproxen sodium are (S)-6-methoxy-a-methyl-2-naphthaleneacetic acid and (S)-6­ methoxy-a-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C 14 H 13 NaO 3 . Naproxen and naproxen sodium have the following structures, respectively: Naproxen is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The inactive ingredients in naproxen tablets include: croscarmellose sodium, magnesium stearate, and povidone. structure-jpg.jpg

Uses • temporarily relieves minor aches and pains due to: o headache o toothache o backache o menstrual cramps o muscular aches o minor pain of arthritis

Uses • temporarily relieves minor aches and pains due to: o backache o muscular aches o minor pain of arthritis o headache o toothache o menstrual cramps

Amphetamine Sulfate is a sympathomimetic amino of the amphetamine group. It is a white, odorless crystalline powder. It has a slightly bitter taste. Its solutions are acid to litmus, having a pH of 5 to 6. It is freely soluble in water, slightly soluble in alcohol and practically insoluble in ether. Each tablet, for oral administration contains 5 mg or 10 mg of amphetamine sulfate, USP. Each tablet also contains the following inactive ingredients: crospovidone, silicified microcrystalline cellulose and stearic acid. The 10 mg tablet also contains FD&C Blue #1 aluminum lake. Structural Formula: structure

Bupropion hydrochloride extended-release tablets (XL) (bupropion hydrochloride), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13 H 18 ClNO•HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is: Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg and 300 mg creamy-white to pale yellow round coated tablets imprinted with black ink on one side and plain on other side. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: ethyl alcohol, ethylcellulose, glyceryl dibehenate, isopropyl alcohol, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, triethyl citrate. In addition, tablets are printed with black ink which contains ferrosoferric oxide, hypromellose, isopropyl alcohol and propylene glycol. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. FDA approved dissolution test specifications differ from USP. bupropion-structure.jpg

Bupropion hydrochloride, USP is an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13 H 18 ClNO•HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is: Bupropion Hydrochloride Extended-Release Tablets, USP (SR), are supplied for oral administration as 100 mg (blue), 150 mg (purple), and 200 mg (light pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: cysteine hydrochloride monohydrate, hydroxypropyl methylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. In addition, the 100 mg tablet contains FD&C Blue #1, the 150 mg tablet contains FD&C Blue #2 and FD&C Red #40, and the 200 mg tablet contains FD&C Red #40. FDA approved dissolution test specifications differ from USP. bupro-sr-structure

Butalbital, Acetaminophen and Caffeine Tablets, USP are supplied in tablet form for oral administration. Each tablet contains the following active ingredients: Butalbital, USP..............................................................50 mg Acetaminophen, USP....................................................325 mg Caffeine, USP................................................................40 mg Inactive Ingredients: microcrystalline cellulose, sodium starch glycolate and magnesium stearate. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following structural formula: C 11 H 16 N 2 O 3 M.W. = 224.26 Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. C 8 H 9 NO 2 M.W. = 151.16 Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula: C 8 H 10 N 4 O 2 M.W. = 194.19 Fig-1 Fig-2 Fig-3

Butalbital, Acetaminophen and Caffeine Capsules USP, are supplied in hard-gelatin capsule form for oral administration. Each capsule contains the following active ingredients: butalbital, USP…………………… 50 mg acetaminophen, USP…………… 300 mg caffeine, USP……………………. 40 mg Inactive Ingredients: crospovidone , FD&C Blue #1, FD&C Red #3, gelatin, microcrystalline cellulose, povidone, pregelatinized starch, sodium lauryl sulfate, stearic acid, talc and titanium dioxide. In addition, capsule printing ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze. Butalbital Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate of molecular weight 224.26. It has the following structural formula: Butalbital Acetaminophen Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic of molecular weight 151.16. It has the following structural formula: Acetaminophen Caffeine Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant of molecular weight 194.19. It has the following structural formula: Caffeine bac-caps-fig1 bac-caps-fig2 bac-caps-fig3

Each capsule for oral administration contains butalbital USP, 50 mg and acetaminophen USP, 300 mg. In addition, each capsule also contains the following inactive ingredients: crospovidone, FD&C Blue #1, FD&C Red #3, gelatin, microcrystalline cellulose, povidone, pregelatinized starch, sodium lauryl sulphate, stearic acid, talc and titanium dioxide. In addition, capsule printing ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze. Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula: C 11 H 16 N 2 O 3 MW 224.26 Acetaminophen (4’-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C 8 H 9 NO 2 MW 151.16 butalbital-acetaminophen-structure1-jpg butalbital-acetaminophen-structure2-jpg

USE(S) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

Uses Cures most ■ Athlete’s foot (tinea pedis) ■ Jock itch (tinea cruris) ■ Ringworm (tinea corporis) Effectively relieves ■ itching ■ cracking ■ burning ■ discomfort which can accompany these conditions.

Colchicine is an alkaloid chemically described as (S)N-(5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo[alpha]heptalen-7-yl) acetamide with a molecular formula of C 22 H 25 NO 6 and a molecular weight of 399.4. The structural formula of colchicine is given below: Colchicine occurs as a pale yellow powder that is soluble in water. Colchicine tablets, USP are supplied for oral administration as purple, film-coated, capsule-shaped tablets (0.1575” X 0.3030”), debossed with “G 02” on one side and scored on the other, containing 0.6 mg of the active ingredient colchicine, USP. Inactive ingredients: FD&C blue #2, FD&C red #40, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, titanium dioxide and triacetin. colchicine-structure-jpg.jpg

Dexmethylphenidate hydrochloride extended-release capsules contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release capsules is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled dexmethylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release capsules are intended for oral administration and is available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C 14 H 19 NO 2 •HCl. Its structural formula is: Note* = asymmetric carbon center Dexmethylphenidate hydrochloride 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. Inactive ingredients : ammonio methacrylate copolymer, gelatin, methacrylic acid and methyl methacrylate copolymer, polyethylene glycol, sugar spheres (which contain sucrose and starch), talc, titanium dioxide, and triethyl citrate. The 5 mg, 25 mg and 35 mg capsule also contains D&C red #28. The 15 mg and 40 mg capsule also contains D&C yellow #10. The 5 mg, 15 mg, 25 mg, 35 mg, and 40 mg capsule also contains FD&C blue #1. The 10 mg, 30 mg and 35 mg capsule also contains FD&C yellow #6. In addition, capsule imprinting ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze. dexmethyl-structure-jpg

A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate. EACH TABLET CONTAINS 5 mg 7.5 mg 10 mg 12.5 mg 15 mg 20 mg 30 mg Dextroamphetamine Saccharate 1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg Amphetamine Aspartate Monohydrate 1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg Dextroamphetamine Sulfate, USP 1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg Amphetamine Sulfate, USP 1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg Total Amphetamine Base Equivalence 3.13 mg 4.7 mg 6.3 mg 7.8 mg 9.4 mg 12.6 mg 18.8 mg Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and pregelatinized starch. 5 mg: White to off white, oval shaped, biconvex tablets, double scored on one side and debossed with “G 5” above “111” on other side. 7.5 mg: White to off white, round, flat faced, beveled edge tablets, double scored on one side and debossed with “G 7.5” above “112” on other side. 10 mg: White to off white, oval shaped, flat faced, beveled edge tablets, double scored on one side and debossed with "G 10 " above "113" on other side. 12.5 mg: White to off white, oval shaped, biconvex tablets, double scored on one side and debossed with "G 12.5" above "114" on other side. 15 mg: White to off white, round, flat faced, beveled edge tablets, double scored on one side and debossed with “G 15” above “115” on other side. 20 mg: White to off white, oval shaped, flat faced, beveled edge tablets, double scored on one side and debossed with "G 20" above "116" on other side. 30 mg: White to off white, oval shaped, biconvex tablets, double scored on one side and debossed with “G 30” above “117” on other side.

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules contain equal amounts (by weight) of four salts: dextroamphetamine sulfate USP, amphetamine sulfate USP, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsule contains two types of drug-containing beads (immediate-release and delayed-release) which prolong the release of amphetamine compared to the Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (immediate-release) tablet formulation. Each capsule contains: Capsule Strength 5 mg 10 mg 15 mg 20 mg 25 mg 30 mg Dextroamphetamine Saccharate 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg Amphetamine (D,L)-Aspartate Monohydrate 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg Dextroamphetamine Sulfate, USP 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg Amphetamine Sulfate, USP 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg Total amphetamine base equivalence 3.1 mg 6.3 mg 9.4 mg 12.5 mg 15.6 mg 18.8 mg d -amphetamine base equivalence 2.4 mg 4.7 mg 7.1 mg 9.5 mg 11.9 mg 14.2 mg l -amphetamine base equivalence 0.75 mg 1.5 mg 2.3 mg 3.0 mg 3.8 mg 4.5 mg Inactive Ingredients and Colors The inactive ingredients in Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules include: gelatin, hypromellose, iron oxide red, iron oxide yellow, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate, sugar spheres, talc, titanium dioxide and triethyl citrate. The 5 mg, 10 mg, and 15 mg capsules also contain FD&C Blue #1 and FD&C Red #3. The 20 mg and 25 mg capsules also contain yellow iron oxide. The 30 mg capsules also contain D&C Yellow #10, FD&C Yellow #6, and yellow iron oxide. In addition, capsule imprinting ink contains black iron oxide, polyethylene glycol and shellac glaze.

Dofetilide is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its empirical formula is C 19 H 27 N 3 O 5 S 2 and it has a molecular weight of 441.6. The structural formula is The chemical name for dofetilide is: N-[4-[2-[methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]-methanesulfonamide. Dofetilide is a white to off-white powder. It is very slightly soluble in water and propan-2-ol and is soluble in 0.1M aqueous sodium hydroxide, acetone, and aqueous 0.1M hydrochloric acid. Dofetilide capsules contain the following inactive ingredients: colloidal silicon dioxide, corn starch, gelatin, magnesium stearate, microcrystalline cellulose and titanium dioxide. The 125 mcg capsules contain FD & C Yellow # 6 and D & C yellow # 10. The 250 mcg and 500 mcg capsules contain FD & C Yellow # 6 and FD& C Red # 40. Dofetilide is supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules. In addition, capsule printing ink contains ammonium hydroxide, black iron oxide, propylene glycol, and shellac glaze. dofetilide-structure-jpg

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ■runny nose ■ itchy, watery eyes ■ sneezing ■ itching of the nose or throat

Glycopyrrolate oral solution is an anticholinergic drug available as an oral solution containing 1 mg glycopyrrolate per 5 mL. The chemical name for glycopyrrolate is pyrrolidinium, 3-[(cyclopentylhydroxyphenylacetyl) oxy]-1,1-dimethyl-,bromide. The chemical structure is: The empirical formula for Glycopyrrolate oral solution is C 19 H 28 BrNO 3 and the molecular weight is 398.33. The inactive ingredients in Glycopyrrolate oral solution are: citric acid anhydrous, natural and artificial cherry flavor, glycerin, methylparaben, propylene glycol, propylparaben, sodium saccharin, sorbitol, trisodium citrate and purified water. glyco-structure-jpg

USE(S) helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Hydrocodone Bitartrate and Acetaminophen is available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula: Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non- opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 5 mg/325 mg contains: Hydrocodone Bitartrate ...... 5 mg Acetaminophen ............... 325 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 7.5 mg/325 mg contains: Hydrocodone Bitartrate ......... 7.5 mg Acetaminophen ..................... 325 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 10 mg/325 mg contains: Hydrocodone Bitartrate .......... 10 mg Acetaminophen ..................... 325 mg In addition, each tablet contains the following inactive ingredients: crospovidone, magnesium stearate, pregelatinized maize starch, povidone, silicified microcrystalline cellulose, and stearic acid. Meets USP Dissolution Test 1. hydroapap-structure-1 hydroapap-structure-2

Levetiracetam is an antiepileptic drug available as 250 mg, 500 mg, 750 mg, and 1,000 mg (white to off-white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8 H 14 N 2 O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam, USP is a white to almost white powder. It is very soluble in water (1,040 mg/ mL). Soluble in acetonitrile (57 mg/ mL) and practically insoluble in hexane. (Solubility limits are expressed as mg/ mL solvent.) Levetiracetam tablets, USP contain the labeled amount of levetiracetam, USP. Inactive ingredients: croscarmellose sodium, magnesium stearate, polyethylene glycol, polyvinyl alcohol, povidone (K-90), pregelatinized starch, talc and titanium dioxide. Meets USP dissolution test 5. structure

Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N -[(1 S )-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15 H 25 N 3 O•(CH 4 O 3 S) 2 , which corresponds to a molecular weight of 455.59 g/mol. The chemical structure is: Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate capsules: Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: croscarmellose sodium, magnesium stearate and microcrystalline cellulose. The capsule shells contain gelatin, titanium dioxide, FD&C Red #3 (in 10 mg), D&C Yellow #10 (in 20 mg), FD&C Yellow #6 (in 20 mg, 30 mg and 70 mg), FD&C Red #40 (in 30 mg and 70 mg), D&C Red #28 (in 30 mg and 70 mg), black iron oxide (in 40 mg), yellow iron oxide (in 40 mg), and FD&C Blue #1 (in 40 mg, 50 mg, 60 mg and 70 mg). In addition, capsule imprinting ink contains ammonia, black iron oxide, potassium hydroxide, propylene glycol and shellac. Lisdexamfe-structure

Lisdexamfetamine dimesylate chewable tablets, a CNS stimulant, are for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N -[(1 S )-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15 H 25 N 3 O•(CH 4 O 3 S) 2 , which corresponds to a molecular weight of 455.59 g/mol. The chemical structure is: Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Information for lisdexamfetamine dimesylate chewable tablets: Lisdexamfetamine dimesylate chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg and 34.7 mg of lisdexamfetamine). Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, N-C fresh strawberry flavor and sucralose. lisdexamfetamine-structure

USE(S) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:  runny nose  sneezing  itchy, water eyes  itching of the nose or throat

Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg, losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg and losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg combine an angiotensin II receptor blocker acting on the AT 1 receptor subtype and a diuretic, hydrochlorothiazide. Losartan potassium, USP a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p- ( o -1 H - tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C 22 H 22 ClKN 6 O, and its structural formula is: Losartan potassium, USP is a white to off-white powder with a molecular weight of 461.00. It is freely soluble in water, sparingly soluble in isopropyl alcohol, and slightly soluble in acetonitrile. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7 H 8 ClN 3 O 4 S 2 and its structural formula is: Hydrochlorothiazide, USP is a white, or practically white crystalline powder, practically odorless with a molecular weight of 297.74, which is very slightly soluble in methanol, sparingly soluble in Acetonitrile, soluble in 1% NaOH solution, practically insoluble or insoluble in water, ethanol and buffer solution with pH value range from 4.5 to 8.0. Losartan potassium and hydrochlorothiazide tablets are available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contains 50 mg of losartan potassium USP and 12.5 mg of hydrochlorothiazide, USP. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contains 100 mg of losartan potassium USP, and 12.5 mg of hydrochlorothiazide USP. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg contains 100 mg of losartan potassium, USP and 25 mg of hydrochlorothiazide USP. Inactive ingredients are hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and titanium dioxide. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg and 100 mg/25 mg also contain iron oxide yellow. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium, losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contains 8.48 mg (0.216 mEq) of potassium, and losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg contains 8.48 mg (0.216 mEq) of potassium. figure-1 figure-2

Metformin Hydrochloride Extended-Release Tablets, USP Metformin hydrochloride extended-release tablets, USP are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride, USP (N,N-dimethyl-monohydrochloride,Imidodicarbonimidic diamide) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown: Metformin hydrochloride, USP is a white or almost white, crystalline powder with a molecular formula of C4H11N5•HCl and a molecular weight of 165.62. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in Methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.35. Metformin hydrochloride extended-release tablets, USP contain 500 mg or 750 mg of metformin hydrochloride as the active ingredient. Metformin hydrochloride extended-release tablets, USP 500 mg and 750 mg tablets contain the inactive ingredients hypromellose, magnesium stearate, and polyvinyl pyrrolidone. Dissolution Method: Test 10 System Components and Performance - Metformin hydrochloride extended-release tablets, USP comprises a dual hydrophilic polymer matrix system. Metformin hydrochloride, USP is combined with a drug release controlling polymer to form an "inner" phase, which is then incorporated as discrete particles into an "external" phase of a second polymer. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. metformin

Methocarbamol tablet, USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 1,2-Propanediol,3-(2-methoxyphenoxy)-,1-Carbamate,(±)-.(or) (±)-3-(o-Methoxyphenoxy)-1,2-Propanediol 1-carbamate and has the empirical formula C 11 H 15 NO 5 . Its molecular weight is 241.24g/mol. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and in chloroform, soluble in alcohol (only with heating), insoluble in benzene and in n-hexane. Methocarbamol tablets, USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets, USP 500 mg are light orange colored, round shaped film coated tablets debossed with "G" above the score line on one side and "500" on other side. Methocarbamol tablets, USP 750 mg are light orange colored, caplet shaped film coated tablets debossed with "G" on one side and "750" on other side. Methocarbamol tablets, USP 500 mg and 750 mg contain the following inactive ingredients: colloidal silicon dioxide, maize starch, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid. The tabets are coated with Aquarius Prime which contains FD&C yellow 6, hydroxypropylcellulose, hypromellose, polysorbate 80, propylene glycol, and titanium dioxide str

Methylergonovine Maleate Tablets, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage. Methylergonovine Maleate Tablets, USP is available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate. Tablets Active ingredient: Methylergonovine maleate, USP, 0.2 mg. Inactive ingredients: acacia, corn starch, gelatin, lactose monohydrate, methylparaben, microcrystalline cellulose, povidone, propylparaben, stearic acid, and tartaric acid. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9,10-didehydro- N -[1-(hydroxy-methyl)propyl]-6-methyl-, [8 β ( S )]-, ( Z )-2-butenedioate (1:1) (salt). Its structural formula is: C 20 H 25 N 3 O 2 •C 4 H 4 O 4 Mol Wt: 455.51 structure.jpg

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 extended-release capsules contains methylphenidate hydrochloride, a 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: Acetyltributyl citrate, cellaburate, corn starch, gelatin, hypromellose acetate succinate, polyethylene glycol, sucrose, talc, and titanium dioxide. The 10 mg, 30 mg, 40 mg, and 60 mg capsules contain FD & C Yellow #6. The 10 mg, 30 mg, and 60 mg capsules also contain FD&C Yellow #5. The 40 mg and 60 mg capsules contain D&C Yellow #10. In addition, capsule printing ink contains ammonium hydroxide, black iron oxide, propylene glycol, and shellac glaze. methylphenidate-struct.jpg

Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: Oxycodone Hydrochloride, USP 2.5 mg* (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.) Acetaminophen, USP 325 mg Oxycodone Hydrochloride, USP 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP 325 mg Oxycodone Hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP 325 mg Oxycodone Hydrochloride, USP 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP 325 mg All strengths of Oxycodone and Acetaminophen Tablets, USP also contain the following inactive ingredients: crospovidone, povidone, pregelatinized maize starch, silicified microcrystalline cellulose, sodium starch glycolate, and stearic acid. Oxycodone and Acetaminophen Tablets, USP contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18 H 21 NO 4 • HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula: Oxycodone and Acetaminophen Tablets, USP contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8 H 9 NO 2 and the molecular weight is 151.16. It may be represented by the following structural formula: oxy-apap-formula oxy-apap-structure

Penicillamine is a chelating agent used in the treatment of Wilson's disease. It is also used to reduce cystine excretion in cystinuria and to treat patients with severe, active rheumatoid arthritis unresponsive to conventional therapy (see INDICATIONS ). It is 3-mercapto-D-valine. It is a white or practically white, crystalline powder, freely soluble in water, slightly soluble in alcohol, and insoluble in ether, acetone, benzene, and carbon tetrachloride. Although its configuration is D, it is levorotatory as usually measured: calculated on a dried basis. The empirical formula is C 5 H 11 NO 2 S, giving it a molecular weight of 149.21. The structural formula is: It reacts readily with formaldehyde or acetone to form a thiazolidine-carboxylic acid. Penicillamine Capsules, USP for oral administration contain 250 mg of penicillamine. Each capsule contains the following inactive ingredients: Anhydrous lactose, FD & C Yellow # 6, gelatin, magnesium stearate, and titanium dioxide. In addition, capsule printing ink contains ammonium hydroxide, black iron oxide, propylene glycol, and shellac glaze. pencillamine-configuration-jpg pencillamine-structure-jpg.jpg

Potassium Chloride, USP, is a white crystalline or colorless solid. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride, USP is K-Cl with a molecular mass of 74.55. Oral Solution 10%: Each 15 mL of solution contains 1.5 g of Potassium Chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, glycerin, methylparaben, natural/artificial orange flavor, propylene glycol, propylparaben, purified water, sucralose, trisodium citrate dihydrate. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of Potassium Chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, glycerin, methylparaben, natural/artificial orange flavor, propylene glycol, propylparaben, purified water, sucralose, trisodium citrate dihydrate.

Potassium chloride extended-release capsules, USP are an oral dosage form of microencapsulated potassium chloride containing 600 mg and 750 mg of potassium chloride, USP, equivalent to 8 mEq and 10 mEq of potassium, respectively. The chemical name of the active ingredient is potassium chloride and the structural formula is KCl. It has a molecular mass of 74.55. Potassium chloride, USP, occurs as a white granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive ingredients: ethylcellulose, hydroxypropyl cellulose. The empty gelatin capsules contain gelatin and titanium dioxide; the 10 mEq capsules contain FD&C Blue #1, FD&C Red #3 and FD&C Yellow #6. In addition, for 8mEq capsule imprinting ink black contains shellac, propylene glycol, black iron oxide, potassium hydroxide and for 10mEq white ink contains shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide. FDA approved dissolution test specifications differ from USP.

Potassium chloride extended-release tablets, USP are a solid oral dosage form of potassium chloride. Each extended-release tablet contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq, respectively of potassium in a wax matrix tablet. Potassium chloride extended-release tablets, USP are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, granular powder or colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive Ingredients: Hydrogenated vegetable oil, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, and titanium dioxide. In addition,10 mEq (750 mg) contains D&C Yellow No. 10 aluminum lake and FD&C Yellow No. 6 aluminum lake and 8 mEq (600 mg) contains FD&C Blue No. 1 aluminum lake, FD&C Blue No.2 aluminum lake, and iron oxide yellow. FDA approved acceptance criteria for Sample preparation in the Assay differs from USP test. Meets USP Dissolution Test 6.

Potassium chloride extended-release tablets, USP 10 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Potassium chloride extended-release tablets, USP 20 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium chloride extended release tablets, USP is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Potassium chloride extended release tablets, USP is a tablet formulation (not enteric-coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, potassium chloride extended release tablets begins disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride, USP Inactive Ingredients : croscarmellose sodium, ethyl cellulose, hydroxypropyl cellulose, microcrystalline cellulose and talc. FDA approved sample preparation in the assay differs from USP test. FDA approved dissolution test specifications differs from USP test.

Potassium Chloride is a white crystalline or colorless solid. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Potassium chloride for oral solution, USP, is a light pink to orange powder with colored speckles. Each pouch contains 1.5 g of potassium chloride(KCl), USP, which is equivalent to potassium 20 mEq and chloride 20 mEq and the following inactive ingredients: citric acid anhydrous, colloidal silicon dioxide, FD&C Yellow #6, natural and artificial orange flavor, and sucralose.