zydus pharmaceuticals (usa) inc. - Medication Listings

Sitagliptin and metformin hydrochloride tablets (sitagliptin and metformin HCl) tablets for oral use contain sitagliptin and metformin HCl. Sitagliptin Sitagliptin is an orally-active inhibitor of DPP-4 enzyme. Sitagliptin is present in sitagliptin and metformin hydrochloride tablets tablets in the form of sitagliptin free base. Sitagliptin free base is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3 (trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine with an empirical formula of C 16 H 15 F 6 N 5 O and a molecular weight of 407.31. The structural formula is: Sitagliptin free base is a white to off-white, non-hygroscopic powder. It is soluble in methanol and slightly soluble in water. Metformin HCl USP Metformin HCl, USP ( N,N -dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. Metformin HCl, 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 HCl is freely soluble in water, slightly soluble in ethanol (95%), practically insoluble in acetone and in methylene chloride. The pKa of metformin HCl is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is as shown: Sitagliptin and metformin hydrochloride tablets is available as film-coated tablets containing: 50 mg of sitagliptin and 389.93 mg of metformin equivalent to 500 mg metformin HCl (sitagliptin and metformin hydrochloride tablets 50/500). 50 mg of sitagliptin and 779.86 mg of metformin equivalent to 1,000 mg metformin HCl (sitagliptin and metformin hydrochloride tablets 50/1,000). Each film-coated tablet of sitagliptin and metformin hydrochloride tablets contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, low substituted hydroxypropylcellulose, magnesium stearate, malic acid, microcrystalline cellulose, povidone, and sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. The film coating of 50 mg/1,000 mg also contains: FD&C yellow #6 aluminum lake, iron oxide red, and iron oxide yellow. Structure Structure

Sodium Phenylacetate and Sodium Benzoate Injection 10% per 10% (a nitrogen binding agent), is a sterile, concentrated, aqueous solution of sodium phenylacetate and sodium benzoate. The pH of the solution is between 7.0 and 8.0. Sodium phenylacetate is a white to off-white powder. It is soluble in water. Sodium benzoate is a white to off-white powder that is readily soluble in water. Figure 1 Sodium phenylacetate has a molecular weight of 158.14 and the molecular formula C 8 H 7 NaO 2 . Sodium benzoate has a molecular weight of 144.10 and the molecular formula C 7 H 5 NaO 2 . Each mL of Sodium Phenylacetate and Sodium Benzoate Injection contains 100 mg of sodium phenylacetate and 100 mg of sodium benzoate, and Water for Injection. Sodium hydroxide and/or hydrochloric acid may have been used for pH adjustment. Sodium Phenylacetate and Sodium Benzoate Injection is a sterile, concentrated solution intended for intravenous administration via a central venous catheter only after dilution [ see Dosage and Administration (2) ]. structure-figure-01

Sodium phenylacetate and sodium benzoate injection (a nitrogen binding agent), is a sterile, concentrated, aqueous solution of sodium phenylacetate and sodium benzoate. The pH of the solution is between 6 and 8. Sodium phenylacetate is a white to off-white powder. It is soluble in water. Sodium benzoate is a white to off-white powder that is readily soluble in water. Figure 1 Sodium phenylacetate has a molecular weight of 158.14 and the molecular formula C 8 H 7 NaO 2 . Sodium benzoate has a molecular weight of 144.10 and the molecular formula C 7 H 5 NaO 2 . Each mL of sodium phenylacetate and sodium benzoate injection contains 100 mg of sodium phenylacetate and 100 mg of sodium benzoate, and Water for Injection. Sodium hydroxide and/or hydrochloric acid may have been used for pH adjustment. Sodium phenylacetate and sodium benzoate injection is a sterile, concentrated solution intended for intravenous administration via a central venous catheter only after dilution [ see Dosage and Administration (2) ]. figure-1

Spironolactone tablets, USP contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula: Spironolactone, USP is practically insoluble in water, soluble in ethyl acetate and alcohol, freely soluble in benzene and in chloroform, slightly soluble in menthanol and very slightly soluble in fixed oils. Inactive ingredients include calcium sulfate dihydrate, colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, peppermint flavor, povidone and sodium lauryl sulfate. Additionally each tablet contains opadry II white 33F28398 which contains hydroxylpropyl methyl cellulose, lactose monohydrate, polyethylene glycol, talc and titanium dioxide. Image

Succinylcholine chloride injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine chloride injection, USP contains succinylcholine chloride, USP as the active pharmaceutical ingredient. Succinylcholine chloride, USP is chemically designated C 14 H 30 Cl 2 N 2 O 4. 2H 2 O and its molecular weight is 397.34 g/mol. The chemical name of succinylcholine chloride is ethanaminium, 2,2'-[(1,4-dioxo-1,4-butanediyl)bis(oxy)]bis[N,N,N-trimethyl-], dichloride, dihydrate. Succinylcholine chloride is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white, odorless, slightly bitter powder, very soluble in water. It has the following structural formula: Succinylcholine chloride injection USP, 200 mg/10 mL (20 mg/mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of succinylcholine chloride injection USP, 200 mg/10 mL (20 mg/mL) multiple-dose fliptop vials contains: 20 mg of succinylcholine chloride, USP (equivalent to 22 mg of succinylcholine chloride dihydrate, USP), 1.8 mg of methylparaben and 0.2 mg of propylparaben as preservatives, 4.60 mg of sodium chloride as iso-osmotic agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.). Image

Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C 22 H 19 N 3 O 4 representing a molecular weight of 389.4. The structural formula is: The chemical designation is pyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. Tadalafil, USP is white or almost white powder that is practically insoluble in water, freely soluble in dimethyl sulfoxide and slightly soluble in methylene chloride. Each Tadalafil Tablet, USP for oral administration contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, and triacetin. Additionally tadalafil tablets of 5 mg, 10 mg and 20 mg also contain iron oxide yellow. tadalafil tablets

Tamsulosin hydrochloride is an antagonist of alpha 1A adrenoceptors in the prostate. Tamsulosin hydrochloride is (-)-( R )-5-[2-[[2-( o -Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride, USP is a white crystalline powder that melts with decomposition at approximately 230°C. It is sparingly soluble in water and methanol, slightly soluble in glacial acetic acid and ethanol, and practically insoluble in ether. The molecular formula of tamsulosin hydrochloride is C 20 H 28 N 2 O 5 S • HCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is: Each tamsulosin hydrochloride capsule intended for oral administration contains tamsulosin hydrochloride 0.4 mg. In addition, each capsule contains the following inactive ingredients: black iron oxide, D&C yellow # 10, FD&C blue # 1, FD&C red # 40, FD&C yellow # 6, gelatin, methacrylic acid copolymer dispersion, microcrystalline cellulose, polysorbate 80, talc, titanium dioxide, triacetin and yellow iron oxide. The capsule is printed with black pharmaceutical ink which contains black iron oxide as a coloring agent. The product meets USP Dissolution Test 8. structured formula for tamsulosin

Telmisartan is a non-peptide angiotensin II receptor (type AT 1 ) antagonist. Telmisartan is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its molecular formula is C 33 H 30 N 4 O 2 , its molecular weight is 514.63, and its structural formula is: Telmisartan, USP is a white or slightly yellowish, crystalline powder. It is practically insoluble in water, slightly soluble in methanol and sparingly soluble in methylene chloride. It dissolves in 1 M sodium hydroxide. Each telmisartan tablets, USP intended for oral administration contains 20 mg or 40 mg or 80 mg of telmisartan. In addition, each tablet contains the following inactive ingredients: ferric oxide red, lactose monohydrate, magnesium stearate, meglumine, povidone, sodium hydroxide, sodium stearyl fumarate and sorbitol. Telmisartan tablets are hygroscopic and require protection from moisture. structure product formula for telmisartan

Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4 trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the molecular formula is C 12 H 9 F 3 N 2 O 2 with the following chemical structure: Teriflunomide is a white to light yellow powder, sparingly soluble in acetone, slightly soluble in ethanol, very slightly soluble in isopropanol and polyethylene glycol-200 and practically insoluble in water. Each film-coated tablet contains teriflunomide 7 mg or 14 mg and the following inactive ingredients: corn starch, hypromellose, silicified microcrystalline cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycols, sodium starch glycolate and titanium dioxide. Additionally, 14 mg tablet contains FD&C blue #2. Teriflunomide Tablets

Tiadylt (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5 H )-one, 3-(acetyloxy)-5-[2(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)- cis -. The chemical structure is: Diltiazem hydrochloride, USP is a white, odourless, crystalline powder or small crystals. It is freely soluble in chloroform, in formic acid, in methanol, and in water; sparingly soluble in dehydrated alcohol; insoluble in ether and has a molecular weight of 450.98. Diltiazem hydrochloride extended-release capsules, USP contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Each Tiadylt ® ER capsules, USP intended for oral administration contains 120 mg or 180 mg or 240 mg or 300 mg or 360 mg or 420 mg of diltiazem hydrochloride. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, gelatin, hypromellose, polyethylene glycol, sugar sphere, talc and titanium dioxide. Additionally each 120 mg, 240 mg and 300 mg capsule shell contains FD & C blue # 1, FD & C red # 3 and FD & C red # 40; each 180 mg and 360 mg capsule shell contains FD & C blue # 1 and FD & C red # 3. Each capsule is printed with black pharmaceutical ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. For oral administration. Meets USP Dissolution Test 18. figure

Tizanidine capsules contains tizanidine hydrochloride as the active ingredient, which is a central alpha 2 -adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. It has a molecular formula of C 9 H 8 ClN 5 S-HCl and a molecular weight of 290.2. Its structural formula is: Tizanidine Hydrochloride is a white to slightly yellow crystalline powder. Tizanidine Hydrochloride is soluble in water and methanol. Tizanidine capsule are for oral administration and contains 2 mg or 4 mg or 6 mg tizanidine (equivalent to 2.29 mg or 4.58 mg or 6.87 mg tizanidine hydrochloride, respectively), the inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose and stearic acid. Each capsule shell contains fd & c blue # 1, fd & c red # 3, gelatin and titanium dioxide. The 2 mg capsule is printed with black pharmaceutical ink which contains black iron oxide, potassium hydroxide and shellac; 4 mg and 6 mg capsule is printed with white pharmaceutical ink which contains potassium hydroxide, shellac and titanium dioxide. figure

Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate capsules, USP are available as 15 mg, 25 mg and 50 mg sprinkle capsules for oral administration as whole capsules or opened and sprinkled onto soft food. Topiramate, USP is a white to off-white crystalline powder with bitter taste. It is freely soluble in dichloromethane. Topiramate has the molecular formula C 12 H 21 NO 8 S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula: Each topiramate tablet, USP intended for oral administration contains 25 mg or 50 mg or 100 mg or 200 mg of topiramate. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide. Each topiramate capsule, USP intended for oral administration contains 15 mg or 25 mg or 50 mg of topiramate. In addition, each capsule contains the following inactive ingredients: cellulose acetate, gelatin, hypromellose, povidone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide and water. Each capsule is printed with black pharmaceutical ink and contains the following inactive ingredients: shellac, propylene glycol, black iron oxide and potassium hydroxide. Topiramate Capsules, USP meet USP dissolution test 2. Structured product formula for Topiramate

Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate capsules, USP are available as 15 mg, 25 mg and 50 mg sprinkle capsules for oral administration as whole capsules or opened and sprinkled onto soft food. Topiramate, USP is a white to off-white crystalline powder with bitter taste. It is freely soluble in dichloromethane. Topiramate has the molecular formula C 12 H 21 NO 8 S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula: Each topiramate tablet, USP intended for oral administration contains 25 mg or 50 mg or 100 mg or 200 mg of topiramate. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide. Each topiramate capsule, USP intended for oral administration contains 15 mg or 25 mg or 50 mg of topiramate. In addition, each capsule contains the following inactive ingredients: cellulose acetate, gelatin, hypromellose, povidone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide and water. Each capsule is printed with black pharmaceutical ink and contains the following inactive ingredients: shellac, propylene glycol, black iron oxide and potassium hydroxide. Topiramate Capsules, USP meet USP dissolution test 2. Structured product formula for Topiramate

Topiramate is a sulfamate-substituted monosaccharide. Topiramate extended-release capsules, USP are available as 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg capsules for oral administration as whole capsules or opened and sprinkled onto a spoonful of soft food. Topiramate, USP is a white to off white crystalline powder. Topiramate is freely soluble in dichloromethane. Topiramate has the molecular formula C 12 H 21 NO 8 S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula: Each topiramate extended-release capsule, USP contains extended-release pellets of topiramate in a capsule. Each capsule contains active ingredient topiramate USP, 25 mg or 50 mg or 100 mg or 150 mg or 200 mg and following inactive ingredients: ethyl cellulose, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, talc and triethyl citrate. Each capsule shell contains hypromellose and titanium dioxide. Additionally, each 25 mg capsule shell contains red iron oxide, 50 mg capsule shell contains yellow iron oxide, 100 mg capsule shell contains black iron oxide, red iron oxide and yellow iron oxide and 200 mg capsule shell contains black iron oxide and yellow iron oxide. The capsule is imprinted with black pharmaceutical ink and contains following inactive ingredients: ferrosoferric oxide, potassium hydroxide, propylene glycol, purified water and shellac. FDA approved dissolution test specifications differ from USP. Image

Topiramate is a sulfamate-substituted monosaccharide. Topiramate extended-release capsules, USP are available as 25 mg, 50 mg, 100 mg and 200 mg capsules for oral administration. Topiramate, USP is a white to off-white crystalline powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12 H 21 NO 8 S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula: Topiramate extended-release capsules, USP contain 25 mg, 50 mg ,100 mg or 200 mg of topiramate. Additionally, each capsule contains the following inactive ingredients: ethyl cellulose, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, talc and triethyl citrate. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide and water. All capsule shells are imprinted with black pharmaceutical ink that contains black iron oxide, potassium hydroxide, propylene glycol and shellac. FDA approved dissolution test specifications differ from USP. Image

Triazolam Tablets contain triazolam, a triazolobenzodiazepine. Triazolam, USP is a white crystalline powder, practically odorless, soluble in chloroform; slightly soluble in alcohol; practically insoluble in ether and in water. It has a molecular weight of 343.2. The chemical name for triazolam is 8-chloro-6-(o-chlorophenyl)-1-methyl-4H-s-triazolo-[4,3-α][1,4] benzodiazepine. The structural formula is represented below: Each triazolam tablet USP, for oral administration, contains 0.125 mg or 0.25 mg of triazolam, USP and contains following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulphate. Additionally, each 0.25 mg tablets contain the FD&C Blue #1 and D&C Red #27. Image

Ursodiol Tablets, USP 250 mg is available as a film-coated tablet for oral administration. Ursodiol Tablets, USP 500 mg is available as a scored film-coated tablet for oral administration. Ursodiol (ursodeoxycholic acid, UDCA) is a naturally occurring bile acid found in small quantities in normal human bile and in larger quantities in the biles of certain species of bears. It is a bitter-tasting white powder consisting of crystalline particles freely soluble in ethanol and glacial acetic acid, slightly soluble in chloroform, sparingly soluble in ether, and practically insoluble in water. The chemical name of ursodiol is 3α,7ß-dihydroxy-5ß-cholan-24-oic (C 24 H 40 O 4 ). Ursodiol has a molecular weight of 392.56. Its structure is shown below. Inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, polyethylene glycol, sodium lauryl sulfate, sodium starch glycolate. The inert ingredients in film coating material are: hypromellose, polyethylene glycol, titanium dioxide. Image

Ursodiol is a bile acid available as 300 mg capsules suitable for oral administration. Ursodiol, USP (ursodeoxycholic acid), is a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. It is a white or almost white crystalline powder, freely soluble in alcohol and glacial acetic acid; slightly soluble in chloroform and ether; and practically insoluble in water. The chemical name for ursodiol is 3α,7β-dihydroxy-5β-cholan-24-oic acid (C 24 H 40 O 4 ). Ursodiol, USP has a molecular weight of 392.6 g/mol. Its structure is shown below: Inactive Ingredients: Hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide and sodium starch glycolate type A. Capsule contains gelatin, FD & C Blue 1, FD & C Red 3 and titanium dioxide. The capsule is printed with black pharmaceutical ink which contains black iron oxide, potassium hydroxide and shellac. FDA approved dissolution method differ from the USP. Image

Vardenafil tablets, USP are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil hydrochloride is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula: Vardenafil hydrochloride trihydrate, USP is white or slightly brown or yellow powder. It is slightly soluble in water, freely soluble in anhydrous ethanol and practically insoluble in heptane. Each tablet contains active ingredient vardenafil 2.5 mg (equivalent to 2.963 mg vardenafil hydrochloride trihydrate) or 5 mg (equivalent to 5.926 mg vardenafil hydrochloride trihydrate) or 10 mg (equivalent to 11.852 mg vardenafil hydrochloride trihydrate) or 20 mg (equivalent to 23.705 mg vardenafil hydrochloride trihydrate) and inactive ingredients: colloidal silicon dioxide, hypromellose, iron oxide red (5 mg, 10 mg and 20 mg), iron oxide yellow (5 mg, 10 mg and 20 mg), microcrystalline cellulose, polyethylene glycol, pregelatinized starch (corn-zea mays), sodium stearyl fumarate, titanium dioxide. Vardenafil tablets

Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α 4 β 2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a white to off-white to slightly yellow powder with the following chemical name: 7,8,9,10-Tetrahydro-6,10-methano-6 H -pyrazino[2,3- h ][3]benzazepine, (2 R ,3 R )-2,3-dihydroxybutanedioate (1:1). It is soluble in water, sparingly soluble in dimethylsulfoxide and slightly soluble in methanol and N,N -dimethylformamide. Varenicline tartrate has a molecular weight of 361.35, and a molecular formula of C 13 H 13 N 3 . C 4 H 6 O 6 . The chemical structure is: Varenicline tablets are supplied for oral administration in two strengths: a 0.5 capsule shaped, biconvex, white to off-white, film-coated tablet debossed with "ZV1" on one side and plain on the other side and a 1 mg capsule shaped, biconvex, light blue to blue, film-coated tablet debossed with "ZV2" on one side and plain on the other side. Each film-coated tablet contains 0.855 mg or 1.71 mg of varenicline tartrate equivalent to 0.5 mg or 1 mg of varenicline free base, respectively. Each tablet contains following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. Additionally, each 1 mg tablet contains FD&C blue #1 aluminum lake. Image

Venlafaxine Extended Release Tablets are extended-release tablets for oral administration that contain venlafaxine hydrochloride, a structurally novel antidepressant. Venlafaxine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated 1-[2-(Dimethylamino)-1-(4-methoxyphenyl)ethyl] Cyclohexanol Hydrochloride salt or (±)-1-[α-[(Dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C 17 H 27 NO 2 HCl. Its molecular weight is 313.86. The structural formula is shown below. Venlafaxine hydrochloride, USP is a white to off-white crystalline powder soluble in methanol and in water. Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine Extended Release Tablets are formulated as extended-release tablet for once-a-day oral administration. Venlafaxine Extended Release Tablets use osmotic pressure to deliver venlafaxine hydrochloride at a controlled rate over approximately 24 hours. The system, which resembles a conventional tablet in appearance, comprises an osmotically active core surrounded by a semipermeable membrane. The unitary tablet core is composed of the drug and excipients (including the osmotically active components). There is a precision-laser drilled orifice in the semipermeable membrane on the side of the tablet. In an aqueous environment, such as the gastrointestinal tract, water permeates through the membrane into the tablet core, causing the drug to dissolve and the osmotic components to expand. This expansion pushes the drug out through the orifice. The semipermeable membrane controls the rate at which water permeates into the tablet core, which in turn controls the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. The function of Venlafaxine Extended Release Tablets depends on the existence of an osmotic gradient between the contents of the core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the feces as an insoluble shell. Each tablets contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, 150 mg or 225 mg venlafaxine. In addition, each tablet contains the following inactive ingredients: cellulose acetate, colloidal silicon dioxide, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol and povidone. The tablet is imprinted with black ink and contains following inactive ingredients: black iron oxide, propylene glycol and shellac. Image

Venlafaxine hydrochloride is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C 17 H 27 NO 2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride Venlafaxine hydrochloride, USP is a white to off-white crystalline powder. It is soluble in methanol and in water. Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Each venlafaxine tablet, USP intended for oral administration contains venlafaxine hydrochloride equivalent to 25 mg or 37.5 mg or 50 mg or 75 mg or 100 mg of venlafaxine. In addition, each tablet contains the following inactive ingredients: ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Structured formula for venlafaxine

Venlafaxine hydrochloride extended-release capsule, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C 17 H 27 NO 2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows: Venlafaxine hydrochloride, USP is a white to off-white crystalline powder; soluble in methanol and in water. Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Venlafaxine hydrochloride extended-release capsules, USP intended for oral administration contains 37.5 mg, 75 mg and 150 mg of venlafaxine. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, cetostearyl alcohol, gelatin, hypromellose, microcrystalline cellulose, polyacrylate dispersion, sodium lauryl sulfate, talc and titanium dioxide. Additionally each 37.5 mg capsule shell contains black iron oxide and each 75 mg and 150 mg capsule shell contains red iron oxide. The capsule is printed with black pharmaceutical ink which contains black iron oxide as coloring agent. The product complies with USP dissolution test 7. Image

Venlafaxine hydrochloride extended-release capsule, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a SNRI. Venlafaxine is designated 1-[2-(Dimethylamino)-1-(4-methoxyphenyl)ethyl] Cyclohexanol Hydrochloride salt or (±)-1-[α- [(dimethylamino)methyl]-pmethoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C 17 H 27 NO 2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows: Venlafaxine hydrochloride, USP is a white to off-white crystalline powder; soluble in methanol and in water. Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Venlafaxine hydrochloride extended-release capsules, USP intended for oral administration contains 37.5 mg, 75 mg and 150 mg of venlafaxine. In addition, each capsule contains the following inactive ingredients: ethyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol and talc. The capsule shell contains gelatin, purified water, sodium lauryl sulfate and titanium dioxide. Additionally each 37.5 mg capsule shell contains iron oxide black and each 75 mg and 150 mg capsule shell contains iron oxide red. The capsule is imprinted with black pharmaceutical ink and contains following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac. Venlafaxine Hydrochloride Extended-Release Capsules, USP meets USP dissolution test 13. Image

Verapamil hydrochloride is a calcium antagonist or slow-channel inhibitor. Verapamil hydrochloride injection, USP is a sterile, nonpyrogenic solution containing verapamil hydrochloride USP 2.5 mg/mL and sodium chloride USP 8.5 mg/mL in water for injection USP. The solution contains no bacteriostat or antimicrobial agent and is intended for single-dose intravenous administration. May contain hydrochloric acid NF or sodium hydroxide NF for pH adjustment; pH is 4.0 to 6.0. The chemical name of verapamil hydrochloride USP is benzeneacetonitrile, α-[3-[{2-(3,4-dimethoxyphenyl)ethyl} methylamino] propyl]-3,4-dimethoxy-α-(1-methylethyl) monohydrochloride. Verapamil hydrochloride USP is a white or practically white crystalline powder. It is practically odorless and has a bitter taste. It is soluble in water; freely soluble in chloroform; sparingly soluble in alcohol; practically insoluble in ether. It has the following structural formula: Molecular weight: 491.06 Molecular formula: C 27 H 38 N 2 O 4 • HCl Verapamil hydrochloride is not chemically related to other antiarrhythmic drugs. Image

Verapamil hydrochloride is a calcium antagonist or slow-channel inhibitor. Verapamil hydrochloride injection, USP is a sterile, nonpyrogenic solution containing verapamil hydrochloride USP 2.5 mg/mL and sodium chloride USP 8.5 mg/mL in water for injection USP. The solution contains no bacteriostat or antimicrobial agent and is intended for single-dose intravenous administration. May contain hydrochloric acid NF or sodium hydroxide NF for pH adjustment; pH is 4.0 to 6.0. The chemical name of verapamil hydrochloride USP is benzeneacetonitrile, α-[3-[{2-(3,4-dimethoxyphenyl)ethyl} methylamino] propyl]-3,4-dimethoxy-α-(1-methylethyl) monohydrochloride. Verapamil hydrochloride USP is a white or practically white crystalline powder. It is practically odorless and has a bitter taste. It is soluble in water; freely soluble in chloroform; sparingly soluble in alcohol; practically insoluble in ether. It has the following structural formula: Molecular weight: 491.06 Molecular formula: C 27 H 38 N 2 O 4 • HCl Verapamil hydrochloride is not chemically related to other antiarrhythmic drugs. Image

Vigabatrin, USP is an oral antiepileptic drug and is available as a white to off-white granular powder for oral solution in packets of 500 mg. The chemical name of vigabatrin USP, a racemate consisting of two enantiomers, is (±) 4-amino-5-hexenoic acid. The molecular formula is C 6 H 11 NO 2 and the molecular weight is 129.16. It has the following structural formula: Vigabatrin, USP is a white or almost white powder which is freely soluble in water and slightly soluble in methanol. The pH of a 1% aqueous solution is about 6.9. The n-octanol/water partition coefficient of vigabatrin, USP is about 0.011 (log P=- 1.96) at physiologic pH. Vigabatrin, USP melts with decomposition in a 3-degree range within the temperature interval of 171°C to 176°C. The dissociation constants (pKa) of vigabatrin, USP are 4 and 9.7 at room temperature (25°C). Vigabatrin for oral solution, USP is available as a white to off-white granular powder. Each packet contains 500 mg of vigabatrin, USP. The inactive ingredient is povidone. Image

Vigabatrin Tablets, USP is an oral antiepileptic drug and is available as a white to off-white film-coated 500 mg tablets. The chemical name of vigabatrin USP, a racemate consisting of two enantiomers, is (±) 4-amino-5-hexenoic acid. The molecular formula is C 6 H 11 NO 2 and the molecular weight is 129.16. It has the following structural formula: Vigabatrin, USP is a white or almost white powder which is freely soluble in water, slightly soluble in methanol; practically insoluble in methylene chloride. The pH of a 1% aqueous solution is about 6.9. The noctanol/ water partition coefficient of vigabatrin, USP is about 0.011 (log P=-1.96) at physiologic pH. Vigabatrin, USP melts with decomposition in a 3-degree range within the temperature interval of 171°C to 176°C. The dissociation constants (pKa) of vigabatrin, USP are 4 and 9.7 at room temperature (25°C). Each vigabatrin tablet contains 500 mg of vigabatrin, USP. The inactive ingredients are hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide. FDA approved dissolution test specifications differ from USP. Image

Zinc Sulfate Injection, USP is a sterile, non-pyrogenic, clear, colorless, and odorless solution intended for use as a trace element and an additive to intravenous solutions for parenteral nutrition. 10 mg/10 mL Pharmacy Bulk Package vial : Each mL contains 1 mg of zinc present as 2.47 mg of zinc sulfate and water for injection q.s. 30 mg/10 mL Pharmacy Bulk Package vial : Each mL contains 3 mg of zinc present as 7.41 mg of zinc sulfate and water for injection q.s. 25 mg/5 mL Pharmacy Bulk Package vial : Each mL contains 5 mg of zinc present as 12.34 mg of zinc sulfate and water for injection q.s. All presentations do not contain preservatives. The pH range is 2 to 4; pH may be adjusted with sulfuric acid. 1 mg/mL of Zinc Sulfate Injection contains no more than 1,500 mcg/L of aluminum and has a calculated osmolarity of 33 mOsmol/L. 3 mg/mL of Zinc Sulfate Injection contains no more than 2,500 mcg/L of aluminum and has a calculated osmolarity of 96.5 mOsmol/L. 5 mg/mL of Zinc Sulfate Injection contains no more than 2,500 mcg/L of aluminum and has a calculated osmolarity of 157.2 mOsmol/L. Zinc sulfate heptahydrate has a molecular weight of 287.54 g/mol and a formula of ZnSO 4 ·7H 2 O. Image Image

ZITUVIMET (sitagliptin and metformin HCl) tablets for oral use contain sitagliptin and metformin HCl. Sitagliptin Sitagliptin is an orally-active inhibitor of DPP-4 enzyme. Sitagliptin is present in ZITUVIMET tablets in the form of sitagliptin free base. Sitagliptin free base is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3 (trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine with an empirical formula of C 16 H 15 F 6 N 5 O and a molecular weight of 407.31. The structural formula is: Sitagliptin free base is a white to off-white, non-hygroscopic powder. It is soluble in methanol and slightly soluble in water. Metformin HCl USP Metformin HCl, USP ( N,N -dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. Metformin HCl, 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 HCl is freely soluble in water, slightly soluble in ethanol (95%), practically insoluble in acetone and in methylene chloride. The pKa of metformin HCl is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is as shown: ZITUVIMET is available as film-coated tablets containing: 50 mg of sitagliptin and 389.93 mg of metformin equivalent to 500 mg metformin HCl (ZITUVIMET 50/500). 50 mg of sitagliptin and 779.86 mg of metformin equivalent to 1,000 mg metformin HCl (ZITUVIMET 50/1,000). Each film-coated tablet of ZITUVIMET contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, low substituted hydroxypropylcellulose, magnesium stearate, malic acid, microcrystalline cellulose, povidone, and sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. The film coating of 50 mg/1,000 mg also contains: FD&C yellow #6 aluminum lake, iron oxide red, and iron oxide yellow. Structure Structure

ZITUVIMET XR tablets for oral use contain two antihyperglycemic medications: sitagliptin and metformin hydrochloride. Sitagliptin Sitagliptin is an orally-active inhibitor of the DPP-4 enzyme. Sitagliptin free base drug substance is used to manufacture ZITUVIMET XR. Sitagliptin free base is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-α]pyrazine with an empirical formula of C 16 H 15 F 6 N 5 O and a molecular weight of 407.31. The structural formula is: Sitagliptin free base is a white to off-white, non-hygroscopic powder. It is soluble in methanol and slightly soluble in water. Metformin HCl Metformin HCl ( N , N -dimethylimidodicarbonimidic diamide HCl) 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 HCl is freely soluble in water, slightly soluble in ethanol (95%), practically insoluble in acetone and in methylene chloride. The pK a of metformin HCl is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is as shown: ZITUVIMET XR ZITUVIMET XR is available as film-coated tablets containing: 50 mg sitagliptin and 389.93 mg of metformin equivalent to 500 mg metformin HCl (ZITUVIMET XR 50/500). 50 mg sitagliptin and 779.86 mg of metformin equivalent to 1,000 mg metformin HCl (ZITUVIMET XR 50/1,000). 100 mg sitagliptin and 779.86 mg of metformin equivalent to 1,000 mg metformin HCl (ZITUVIMET XR 100/1,000). All doses of ZITUVIMET XR contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate anhydrous, ferric oxide yellow, hypromellose, magnesium stearate, malic acid, microcrystalline cellulose, povidone, pregelatinized starch (maize) and sodium stearyl fumarate. In addition, the film-coating for all doses contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, iron oxide yellow, talc and titanium dioxide. Additionally, ZITUVIMET XR 50 mg/500 mg and 100 mg/1,000 mg tablets film-coating contain the inactive ingredient red iron oxide and 50 mg/1,000 mg and 100 mg/1,000 mg tablets film-coating contain the FD&C yellow#6 Aluminum Lake. Image Image

ZITUVIO Tablets contain sitagliptin free base, an orally active inhibitor of the DPP-4 enzyme. Sitagliptin free base is described chemically as 7-[(3 R )-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3- a ]pyrazine. The empirical formula is C 16 H 15 F 6 N 5 O and the molecular weight is 407.31. The structural formula is: Sitagliptin free base is a white to off-white, non-hygroscopic powder. Sitagliptin free base is soluble in methanol and slightly soluble in water. Each film coated tablet of ZITUVIO contains sitagliptin free base 25 mg, 50 mg, or 100 mg as active ingredient and the following inactive ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, malic acid, magnesium stearate, microcrystalline cellulose, and povidone. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. The 50 mg tablet's film coating also contains ferrosoferric oxide and iron oxide yellow. The 100 mg tablet's film coating also contains FD&C Yellow #6 Aluminum Lake and iron oxide yellow. Image

Zolmitriptan orally disintegrating tablets contain zolmitriptan, which is a selective 5-hydroxytryptamine 1B/1D (5 -HT 1B/1D ) receptor agonist. Zolmitriptan is chemically designated as (S)-4-[[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]methyl]-2-oxazolidinone and has the following chemical structure: The molecular formula is C 16 H 21 N 3 O 2 , representing a molecular weight of 287.36. Zolmitriptan, USP is white to off-white crystalline powder that is freely soluble to soluble in methanol and soluble in water, sparingly soluble in dichloromethane, practically insoluble in toluene. Each zolmitriptan orally disintegrating tablet USP, intended for oral administration,contains 2.5 mg or 5 mg of zolmitriptan USP. In addition, each tablet contains the following inactive ingredients: anhydrous citric acid, aspartame, colloidal silicon dioxide, crospovidone, gelatin, magnesium stearate,mannitol, microcrystalline cellulose, orange flavor, polacrilin potassium and sodium stearyl fumarate. Structural Formula