glenmark pharmaceuticals inc., usa - Medication Listings

Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/ 0.03 mg provide an oral contraceptive regimen consisting of 28 film-coated tablets that contain the ingredients specified for each tablet below: • 21 light yellow to yellow tablets each containing 3 mg DRSP and 0.03 mg EE • 7 inert white to off-white tablets The inactive ingredients in the light yellow to yellow tablets are corn starch, crospovidone, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide. The white to off-white inert film-coated tablets contain anhydrous lactose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide. Drospirenone, USP (6R, 7R, 8R, 9S, 10R, 13S, 14S, 15S, 16S, 17S)-1,3’,4’,6, 6a, 7, 8, 9, 10, 11, 12, 13, 14, 15, 15a, 16-hexadecahydro10, 13-dimethylspiro-[17H-dicyclopropa-[6 ,7:15, 16] cyclopenta[a]phenanthrene-17, 2’(5H)-furan]-3, 5’(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.49 and a molecular formula of C 24 H 30 O 3 . Ethinyl estradiol, USP (19-nor-17α-pregna 1,3,5(10)-triene-20-yne-3, 17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C 20 H 24 O 2 . The structural formulas are as follows: Drospirenone, USP Ethinyl Estradiol, USP USP Dissolution Test pending. drospirenone structure ethinylestradiolstructure

Epinephrine Injection USP, 1 mg/mL is supplied as a sterile aqueous solution with a pH range of 2.2 to 5.0, that is colorless and nonpyrogenic. Each milliliter contains 1 mg epinephrine, sodium chloride 8.6 mg (for isotonicity), hydrochloric acid 6 mg as a dissolution agent, hydrochloric acid for pH adjustment, and water for injection, USP, q.s. Contains no preservatives or sulfites. Solution must be diluted prior to intravenous or ocular use. Epinephrine, USP is a sympathomimetic catecholamine (adrenergic agent) designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula: The molecular weight of epinephrine is 183.2. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. epinephrine-spl-structure

Epinephrine Injection, USP is a clear, colorless, sterile solution containing 1 mg/mL epinephrine. 10 mL Multiple-Dose Vial: 10 mL multiple-dose amber glass vial containing 10 mg/10 mL (1 mg/mL) epinephrine as a sterile, nonpyrogenic, clear and colorless solution. In the 10 mL vial, each 1 mL of Epinephrine Injection, USP solution contains 1 mg epinephrine, 5.25 mg chlorobutanol hemihydrate as preservative, 7.5 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid for pH adjustment and water for injection. The pH range is 2.2 to 5.0. 30 mL Multiple Dose Vial: 30 mL multiple dose amber glass vial containing 30 mg/30 mL epinephrine as a sterile, nonpyrogenic, clear and colorless solution. In the 30 mL vial, each 1 mL of Epinephrine Injection USP solution contains 1 mg epinephrine, 5.25 mg chlorobutanol hemihydrate as preservative, 7.5 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid for pH adjustment and water for injection. The pH range is 2.2 to 5.0. Epinephrine is a sympathomimetic catecholamine. The chemical name of epinephrine is: 1,2-Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]-, or (-)-3,4-Dihydroxy-α-[2- (methylamino)ethyl]benzyl alcohol. The chemical structure of epinephrine is: The molecular weight of epinephrine is 183.2. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. structure.jpg

Eribulin mesylate injection contains eribulin mesylate, a microtubule dynamics inhibitor. Eribulin mesylate is a synthetic analogue of halichondrin B, a product isolated from the marine sponge Halichondria okadai . The chemical name for eribulin mesylate is 11,15:18,21:24,28- Triepoxy-7,9-ethano-12,15-methano-9 H ,15 H -furo[3,2- i ]furo[2',3':5,6]pyrano[4,3- b ][1,4]dioxacyclopentacosin-5(4 H )-one, 2-[(2 S )-3-amino-2-hydroxypropyl]hexacosahydro-3-methoxy-26-methyl-20,27-bis(methylene)-, (2 R ,3 R ,3a S ,7 R ,8a S ,9 S ,10a R ,11 S ,12 R ,13a R ,13b S ,15 S ,18 S ,21 S ,24 S ,26 R ,28 R ,29a S )-, methanesulfonate (salt). It has a molecular weight of 826.0 (729.9 for free base). The empirical formula is C 40 H 59 NO 11 •CH 4 O 3 S. Eribulin mesylate has the following structural formula: Eribulin mesylate injection is a clear, colorless, sterile solution for intravenous administration. Each single-dose vial contains 1 mg of eribulin mesylate in 2 mL of solution. Each mL of solution contains 0.5 mg of eribulin mesylate (equivalent to 0.44 mg eribulin) in dehydrated alcohol (5% v/v) and water for injection (95% v/v). Sodium hydroxide or hydrochloric acid may be used for pH adjustment. image1

Estradiol vaginal inserts, USP 10 mcg are white to off-white, round, film-coated, bi-convex vaginal inserts, debossed with ‘G’ on one side and ‘94’ on the other side and containing 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. Each estradiol vaginal insert, USP 10 mcg contains the following excipients: colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, and magnesium stearate. The film coating contains hypromellose and polyethylene glycol. Each estradiol vaginal insert, USP is 6 mm in diameter and is placed in a disposable applicator. Each insert-filled applicator is packaged separately in a blister pack. Estradiol vaginal inserts, USP, 10 mcg are used intravaginally. When the insert comes in contact with the vaginal mucosa, estradiol, USP is released into the vagina. Estradiol hemihydrate, USP is a white, almost white, crystalline powder, chemically described as (8R,9S,13S,14S,17S)-13-methyl-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta[a]phenanthrene-3,17-diol. The chemical formula is C 18 H 24 O 2 • ½ H 2 O with a molecular weight of 281.39. The structural formula is: USP Dissolution Test Pending. structure

Eszopiclone is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-4-Methylpiperazine-1-carboxylic acid 6-(5-chloro-2-pyridyl)-7-oxo-6, 7-dihydro-5 H-pyrrolo [3,4-b]pyrazin-5(S)-yl ester. Its molecular weight is 388.81 g/mol, and its empirical formula is C 17 H 17 ClN 6 O 3 . Eszopiclone has a single chiral center with an ( S )-configuration. It has the following chemical structure: Eszopiclone is a white to light yellow powder. Eszopiclone is slightly soluble in acetone, methanol and alcohol; practically insoluble in water. Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone Tablets, USP contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2. eszopiclone-chemical-structure

Ezetimibe is in a class of lipid‑lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. The chemical name of ezetimibe, USP is 1‑(4‑fluorophenyl)‑3(R)‑[3‑(4‑fluorophenyl)‑3(S)‑ hydroxypropyl]‑4(S)‑(4‑hydroxyphenyl)‑2‑azetidinone. The empirical formula is C 24 H 21 F 2 NO 3 . Its molecular weight is 409.4 and its structural formula is: Ezetimibe, USP is a white crystalline powder that is freely soluble in ethanol, methanol, and acetone and practically insoluble in water. Ezetimibe, USP has a melting point of about 163°C and is stable at ambient temperature. Ezetimibe Tablets, USP is available as a tablet for oral administration containing 10 mg of ezetimibe, USP and the following inactive ingredients: lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate, and sodium starch glycolate. FDA approved dissolution test specifications differ from USP. structure

Ezetimibe and Simvastatin Tablets contain ezetimibe, a dietary cholesterol absorption inhibitor and simvastatin, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C 24 H 21 F 2 NO 3 and its molecular weight is 409.44 g/mol. Ezetimibe is a white, crystalline powder that is freely soluble in ethanol, methanol and acetone and practically insoluble in water. Its structural formula is: Simvastatin, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H -pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S -[1α,3α,7α,8α(2 S* ,4 S* ),-8aβ]]. The molecular formula of simvastatin is C 25 H 38 O 5 and its molecular weight is 418.57 g/mol. Simvastatin is a white to off-white, nonhygroscopic powder that is freely soluble in chloroform, methanol and alcohol, sparingly soluble in propylene glycol, very slightly soluble in hexane and practically insoluble in water. Its structural formula is: Ezetimibe and Simvastatin Tablets are available for oral use as tablets containing 10 mg of ezetimibe, and 10 mg of simvastatin (Ezetimibe and Simvastatin Tablets 10 mg/10 mg), 20 mg of simvastatin (Ezetimibe and Simvastatin Tablets 10 mg/20 mg), 40 mg of simvastatin (Ezetimibe and Simvastatin Tablets 10 mg/40 mg), or 80 mg of simvastatin (Ezetimibe and Simvastatin Tablets 10 mg/80 mg). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propyl gallate, and sodium lauryl sulfate. ezetimibe-structure simva-structure

Felodipine extended-release tablets USP are a calcium antagonist (calcium channel blocker). Felodipine is a dihydropyridine derivative that is chemically described as ± ethyl methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate. Its molecular formula is C 18 H 19 Cl 2 NO 4 and its structural formula is: Felodipine USP is a slightly yellowish, crystalline powder with a molecular weight of 384.26. It is insoluble in water and is freely soluble in dichloromethane and ethanol. Felodipine is a racemic mixture. Felodipine extended-release tablets provide extended-release of felodipine. They are available as tablets containing 2.5 mg, 5 mg, or 10 mg of felodipine for oral administration. In addition to the active ingredient felodipine, the felodipine extended-release tablets 2.5 mg, 5 mg and 10 mg contain the following inactive ingredients: hydroxypropyl cellulose, hypromellose, kaolin, lactose monohydrate, microcrystalline cellulose, polyoxyl 40 hydrogenated castor oil, sodium stearyl fumarate, Opadry Green 20B51525 (2.5 mg), Opadry Pink 20B84706 (5 mg) and Opadry Red 20B55372 (10 mg). Opadry Green 20B51525 consists of hypromellose, hydroxypropyl cellulose, macrogol, titanium dioxide, D&C Yellow No. 10 Aluminium Lake, FD&C Blue No. 2 Aluminium Lake and ferric oxide yellow. Opadry Pink 20B84706 consists of hypromellose, hydroxypropyl cellulose, macrogol, titanium dioxide, ferric oxide red and ferric oxide yellow. Opadry Red 20B55372 consists of hypromellose, hydroxypropyl cellulose, macrogol, titanium dioxide, ferric oxide red and ferric oxide yellow. structure

Fenofibrate, USP (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate, USP. The chemical name for fenofibrate, USP is Isopropyl 2-[ p -( p -chlorobenzoyl)phenoxy]-2-methylpropanoate with the following structural formula: The molecular formula is C 20 H 21 Cl O 4 and the molecular weight is 360.83 g/mol. Fenofibrate, USP is practically insoluble in water, very soluble in methylene chloride and slightly soluble in alcohol. The melting point is 79°C to 82°C. Fenofibrate, USP is a white or almost white, crystalline powder which is stable under ordinary conditions. Each 67 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: black iron oxide, colloidal silicon dioxide, crospovidone, D&C Red #28, FD&C Blue #1, FD&C Red #40, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, povidone, pregelatinized starch, shellac, sodium lauryl sulfate, talc and titanium dioxide. Each 134 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: black iron oxide, colloidal silicon dioxide, crospovidone, D&C Red #28, FD&C Blue #1, gelatin, lactose monohydrate, magnesium stearate, potassium hydroxide, povidone, pregelatinized starch, shellac, sodium lauryl sulfate, talc and titanium dioxide. Each 200 mg fenofibrate capsule, USP (micronized) contains the following inactive ingredients: black iron oxide, colloidal silicon dioxide, crospovidone, D&C Red #28, FD&C Red #40, gelatin, iron oxide yellow, lactose monohydrate, magnesium stearate, potassium hydroxide, povidone, pregelatinized starch, shellac, sodium lauryl sulfate, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP. structure

Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod hydrochloride is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below: Fingolimod hydrochloride, USP is a white to off-white powder that is freely soluble in alcohol, soluble in methanol, water and propylene glycol. It has a molecular weight of 343.93 g/mol. Fingolimod Capsules are provided as 0.5 mg hard gelatin capsules for oral use. Each 0.5 mg capsule contains 0.56 mg of fingolimod hydrochloride, USP equivalent to 0.5 mg fingolimod. Each fingolimod 0.5 mg capsule contains the following inactive ingredients: magnesium stearate and pregelatinized starch. The capsule shell contains gelatin, iron oxide yellow and titanium dioxide. The imprinting ink contains iron oxide black, potassium hydroxide and shellac. structure

Fluconazole, USP the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole, USP is designated chemically as 2,4-difluoro-1 ’ ,1 ’ -bis(1 H -1,2,4-triazol-1-ylmethyl)benzyl alcohol with an empirical formula of C 13 H 12 F 2 N 6 O and molecular weight of 306.27. The structural formula is: Fluconazole, USP is a white or almost white crystalline powder which is freely soluble in methanol; soluble in alcohol and in acetone; sparingly soluble in isopropanol and in chloroform; slightly soluble in water; very slightly soluble in toluene. Fluconazole Tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Red No. 40, magnesium stearate, microcrystalline cellulose and povidone K-30. structure

Fluocinolone Acetonide Oil, 0.01% (Ear Drops) contain fluocinolone acetonide, USP {(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone}, a synthetic corticosteroid. Chemically, fluocinolone acetonide, USP is C 24 H 30 F 2 O 6 . It has the following structural formula: Fluocinolone acetonide, USP in Fluocinolone Acetonide Oil, 0.01% (Ear Drops) has a molecular weight of 452.49. It is a white or almost white, crystalline powder and melts at 270°C with decomposition; practically insoluble in water and heptane, soluble in methanol, anhydrous ethanol and acetone, slightly soluble in ether and chloroform. Each gram of Fluocinolone Acetonide Oil, 0.01% (Ear Drops) contains approximately 0.11 mg of fluocinolone acetonide, USP in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. structure.jpg

Fluocinolone Acetonide Topical Oil, 0.01% contains fluocinolone acetonide, USP (6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene) bis-(oxy)]-pregna-1,4-diene-3,20-dione, a synthetic corticosteroid for topical dermatologic use. This formulation is also marketed as Fluocinolone Acetonide Topical Oil, 0.01%, fluocinolone acetonide for use as body oil for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older and as fluocinolone acetonide oil, 0.01% for chronic eczematous external otitis. Chemically, fluocinolone acetonide, USP is C 24 H 30 F 2 O 6 . It has the following structural formula: Fluocinolone acetonide, USP in Fluocinolone Acetonide Topical Oil, 0.01% has a molecular weight of 452.49. It is a white to almost white, crystalline powder and melts at about 270°C with decomposition; practically insoluble in water and heptane, soluble in methanol, anhydrous ethanol and acetone, slightly soluble in ether and chloroform. Each gram of Fluocinolone Acetonide Topical Oil, 0.01% contains approximately 0.11 mg of fluocinolone acetonide, USP in a blend of oils, which contains anhydrous citric acid, isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil. Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic. chemical-structure

Fluocinonide cream USP, 0.1% contains fluocinonide USP, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide USP has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is C 26 H 32 F 2 O 7 and it has a molecular weight of 494.52. It has the following chemical structure: Fluocinonide is a white powder. It is sparingly soluble in acetone and inchloroform; slightly soluble in alcohol, methanol, dioxane, acetonitrile and ethyl acetate; very slightly soluble inether; and practically insoluble in water. Each gram of fluocinonide cream USP, 0.1%contains 1 mg micronized fluocinonide USP in a cream base of propylene glycol, diethylene glycol monoethyl ether, glyceryl stearate (and) PEG-100 stearate, glyceryl monostearate, purified water, carbomer, diisopropanolamine and anhydrous citric acid. structure

Fluphenazine hydrochloride, USP is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. The chemical designation is 4-[3-[2-(trifluoromethyl) phenothiazin-10-yl] propyl]-1-piperazine-ethanol dihydrochloride. The structural formula is represented below: Molecular Formula: C 22 H 26 F 3 N 3 OS·2HCl Molecular Weight: 510.44 Fluphenazine Hydrochloride Tablets, USP, for oral administration, contain 1 mg, 2.5 mg, 5 mg, or 10 mg fluphenazine hydrochloride, USP per tablet. Each tablet also contains colloidal silicon dioxide, croscarmellose sodium, D&C Red No. 27 (2.5 mg tablet), D&C Yellow No. 10 (1 mg and 5 mg tablet), FD&C Blue No. 2 (1 mg, 2.5 mg and 5 mg tablet), FD&C Red No. 40 (10 mg tablet), FD&C Yellow No. 6 (1 mg, 5 mg and 10 mg tablet), hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, purified water, and titanium dioxide. checmicalstructure

Fluticasone propionate lotion USP, 0.05% contains fluticasone propionate USP S -Fluoromethyl 6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxyandrosta-1,4-diene-17β-carbothioate, a synthetic fluorinated corticosteroid, for topical use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Chemically, fluticasone propionate USP is C 25 H 31 F 3 O 5 S. It has the following structural formula: Fluticasone propionate USP is a white or almost white powder with a molecular weight of 500.6 g/mol. It is freely soluble in dimethylformamide; slightly soluble in alcohol; sparingly soluble in acetone and in dichloromethane; insoluble in water. Each gram of fluticasone propionate lotion USP contains 0.5 mg fluticasone propionate USP in a base of cetostearyl alcohol, polyoxyl 20 cetostearyl ether, citric acid anhydrous, dimethicone 360, isopropyl myristate, light mineral oil, propylene glycol, sodium citrate anhydrous, sorbitan monostearate, and purified water, with imidurea, methylparaben, and propylparaben as preservatives. chemical-structure

Fosphenytoin sodium injection, USP is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium USP is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg phenytoin sodium equivalents (PE). The amount and concentration of fosphenytoin is always expressed in terms of mg PE . The pharmacological class of the fosphenytoin sodium is hydantoin derivative, and the therapeutic class is anticonvulsant. Fosphenytoin sodium injection, USP is marketed in 2 mL vials containing a total of 100 mg PE/2mL (50 mg PE/mL) and 10 mL vials containing a total of 500 mg PE/10mL (50 mg PE/mL), for intravenous or intramuscular administration. The concentration of each vial is 50 mg PE/mL. Fosphenytoin sodium injection, USP is supplied in vials as a sterile solution in Water for Injection, USP, and Tromethamine, USP (TRIS) (12 mg/mL), buffer adjusted to pH 8.6 to 9.0 with either Hydrochloric Acid, NF, or Sodium Hydroxide, NF. Fosphenytoin sodium injection, USP is a clear, colorless to pale yellow, sterile solution. The chemical name of fosphenytoin is 5,5-diphenyl-3-[(phosphonooxy)methyl]-2,4-imidazolidinedione disodium salt. The molecular structure of fosphenytoin is: The molecular weight of fosphenytoin is 406.24. structure

Fosphenytoin sodium injection, USP is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium USP is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg phenytoin sodium equivalents (PE). The amount and concentration of fosphenytoin is always expressed in terms of mg PE . The pharmacological class of the fosphenytoin sodium is hydantoin derivative, and the therapeutic class is anticonvulsant. Fosphenytoin sodium injection, USP is marketed in 10 mL vials containing a total of 500 mg PE/10mL (50 mg PE/mL), for intravenous or intramuscular administration. The concentration of each vial is 50 mg PE/mL. Fosphenytoin sodium injection, USP is supplied in vials as a sterile solution in Water for Injection, USP, and Tromethamine, USP (TRIS) (12 mg/mL), buffer adjusted to pH 8.6 to 9.0 with either Hydrochloric Acid, NF, or Sodium Hydroxide, NF. Fosphenytoin sodium injection, USP is a clear, colorless to pale yellow, sterile solution. The chemical name of fosphenytoin is 5,5-diphenyl-3-[(phosphonooxy)methyl]-2,4-imidazolidinedione disodium salt. The molecular structure of fosphenytoin is: The molecular weight of fosphenytoin is 406.24. structure

Frovatriptan succinate tablets contain frovatriptan succinate, a selective 5-hydroxytryptamine1 (5-HT 1B / 1D ) receptor subtype agonist, as the active ingredient. Frovatriptan succinate is chemically designated as R-(+) 3-methylamino-6-carboxamido-1,2,3,4-tetrahydrocarbazole monosuccinate monohydrate and it has the following structure: The molecular formula is C 18 H 23 N 3 O 5 .H 2 O, representing a molecular weight of 379.4 g/mol. Frovatriptan succinate is a white to off-white powder that is soluble in water and very slightly soluble in methanol. Each frovatriptan succinate tablet for oral administration contains 3.91 mg frovatriptan succinate, equivalent to 2.5 mg of frovatriptan base. Each tablet also contains the inactive ingredients anhydrous lactose, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate (potato), talc, titanium dioxide and triacetin. structure

Hailey ® 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP) is a progestogen-estrogen combinations. Hailey 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP) provides a continuous dosage regimen consisting of 21 light green to green oral contraceptive tablets. Each light green to green tablet, for oral administration, contains 1.5 mg norethindrone acetate, USP [(17α)-17-(acetyloxy)-19-norpregn-4-en-20-yn-3-one] and 30 mcg ethinyl estradiol, USP [19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol]. The tablets also contain the following inactive ingredients: acacia, corn starch, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, lactose monohydrate, magnesium stearate, sucrose, and talc. The structural formulas are as follows: Norethindrone Acetate, USP Ethinyl Estradiol, USP norethindrone eestructure

Hailey ® 24 Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets, USP) is a combination oral contraceptive for oral administration consisting of active tablets containing norethindrone acetate, USP, a progestin, and ethinyl estradiol, USP, an estrogen, and placebo tablets containing ferrous fumarate, USP which serve no therapeutic purpose. • Each active white to off-white tablet contains 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP. Inactive ingredients include acacia, corn starch, lactose monohydrate, magnesium stearate, sucrose and talc. • Each placebo brown to dark brown tablet contains 75 mg ferrous fumarate, microcrystalline cellulose, magnesium stearate, povidone, sodium starch glycolate, corn starch and talc. The ferrous fumarate tablets do not serve any therapeutic purpose. The chemical name of ethinyl estradiol, USP is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. The empirical formula of ethinyl estradiol, USP is C 20 H 24 O 2 and the structural formula is: The chemical name of norethindrone acetate, USP is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]. The empirical formula of norethindrone acetate, USP is C 22 H 28 O 3 and the structural formula is: image-01 image-02

Hailey ® Fe 1/20 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets, USP) is a progestogen-estrogen combination. Hailey Fe 1/20 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets, USP): provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each white to off-white tablet contains norethindrone acetate, USP [(19-Norpregn-4-en-20-yn-3-one,17-(acetyloxy)-, (17α)], 1 mg; ethinyl estradiol, USP [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-], 20 mcg. Also contains acacia, lactose monohydrate, magnesium stearate, corn starch, sucrose and talc. The structural formulas are as follows: Norethindrone Acetate, USP Ethinyl Estradiol, USP Each brown to dark brown tablet contains microcrystalline cellulose, ferrous fumarate, magnesium stearate, povidone, sodium starch glycolate, corn starch and talc. The ferrous fumarate tablets do not serve any therapeutic purpose. NorStructure eestructure

Hailey ® Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets, USP) is a progestogen-estrogen combination. Hailey Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets, USP): provides a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each light green to green tablet, for oral administration, contains 1.5 mg norethindrone acetate, USP [(17α)-17-(acetyloxy)-19-norpregn-4-en-20-yn-3-one] and 30 mcg ethinyl estradiol, USP [19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol]. The tablets also contain the following inactive ingredients: acacia, corn starch, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, lactose monohydrate, magnesium stearate, sucrose, and talc. The structural formulas are as follows: Norethindrone Acetate, USP Ethinyl Estradiol, USP Each brown to dark brown tablet for oral administration contains ferrous fumarate, acacia, corn starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, sucralose, and talc. The ferrous fumarate tablets do not serve any therapeutic purpose. norstructure eestructure

Each pale yellow HEATHER tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone, USP daily, and the inactive ingredients include corn starch, lactose monohydrate, magnesium stearate, povidone, talc, D&C Yellow No. 10 aluminium lake and FD&C Yellow No. 6 aluminium lake. The chemical name for norethindrone, USP is 17-Hydroxy-19-Nor-17α-pregn-4-en-20-yn-3-one. The structural formula follows: Norethindrone, USP Therapeutic class = oral contraceptive Structure of Norethindrone

Hydralazine Hydrochloride Tablets, USP is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is: C 8 H 8 N 4 •HCl Hydralazine hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275 o C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, USP. Tablets also contain mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid and FDC Yellow No. 6. Structural Formula for Hydralazine

Hydrocortisone Valerate Ointment USP, 0.2% contains hydrocortisone valerate, USP, pregn-4-ene-3,20-dione, 11,21-dihydroxy-17-[(1-oxopentyl)oxy]-, (11β)-;cortisol 17-valerate or 11β,17,21-Trihydroxypregn-4-ene-3,20-dione 17-valerate, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, hydrocortisone valerate, USP is C 26 H 38 O 6 . It has the following structural formula: Hydrocortisone valerate, USP has a molecular weight of 446.58. It is a white or almost white crystalline powder, freely soluble in acetone and dichloromethane; soluble in alcohol; insoluble in water. Each gram of Hydrocortisone Valerate Ointment, USP, 0.2% contains 2 mg hydrocortisone valerate, USP in a hydrophilic base composed of citric acid monohydrate, methyl paraben, mineral oil, polyoxyl stearyl ether, propylene glycol, sepineo P 600, steareth 100, stearyl alcohol, sodium lauryl sulfate, white petrolatum and purified water. structure

Imiquimod cream USP is an immune response modifier for topical administration. Each gram contains 50 mg of imiquimod, USP in an off-white oil-in-water vanishing cream base consisting of benzyl alcohol, cetyl alcohol, glycerin, isostearic acid, methylparaben, polysorbate 60, propylparaben, purified water, sorbitan monostearate, stearyl alcohol, white petrolatum and xanthan gum. Chemically, imiquimod, USP is 1-(2-methylpropyl)-1 H-imidazo[4,5-c]quinolin-4-amine. Imiquimod, USP has a molecular formula of C 14 H 16 N 4 and a molecular weight of 240.3 g/mol. Its structural formula is: structure.jpg

Indomethacin Extended-Release Capsules, USP are non-steroidal anti-inflammatory drugs, available as capsules containing 75 mg of indomethacin, USP, administered for oral use. The chemical name is 1-(p-chlorobenzoyl)-5-methoxy-2-methylindole-3-acetic acid. The molecular weight is 357.79 g/mol. Its molecular formula is C 19 H 16 ClNO 4 . The structural formula is: Indomethacin, USP is a white to yellow crystalline powder. It is practically insoluble in water; sparingly soluble in alcohol, chloroform, and ether. A pKa of 4.5 for the carboxyl group of indomethacin, USP was calculated from the aqueous solubility data. Potentiometric titration data in 50 % methanol-water yielded pKa of 4.5 using a correction factor for the solvent. The inactive ingredients in Indomethacin Extended-Release Capsules, USP 75 mg include: black iron oxide, D&C yellow No. 10, ethylcellulose, FD&C blue No. 1, FD&C red No. 40, gelatin, hypromellose, lactose monohydrate, polyethylene glycol, potassium hydroxide, shellac, sodium lauryl sulfate, sugar spheres, talc and titanium dioxide. This product meets USP Dissolution Test 2. structure

Indomethacin Capsules, USP are nonsteroidal anti-inflammatory drugs, available as capsules containing 25 mg and 50 mg of indomethacin, USP, administered for oral use. The chemical name is 1-( p -chlorobenzoyl)-5-methoxy-2-methylindole-3-acetic acid. The molecular weight is 357.79 g/mol. Its molecular formula is C 19 H 16 ClNO 4 , and it has the following chemical structure. Indomethacin, USP is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol, chloroform, and in ether. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in Indomethacin Capsules, USP 25 mg and 50 mg include: colloidal silicon dioxide, FD&C Blue No. 1, FD&C Yellow No. 5, gelatin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide. The imprinting ink contains: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Struture.jpg

Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1 H -pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in Figure 1. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40. Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, 4.35 mg, and 8.70 mg, respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color. ketrolac-spl-structure

11.1 Lacosamide Tablets The chemical name of lacosamide, USP the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide, USP is a functionalized amino acid. Its molecular formula is C 13 H 18 N 2 O 3 and its molecular weight is 250.3 g/mol. The chemical structure is: Lacosamide, USP is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol. Lacosamide Tablets, USP for oral administration contain lacosamide, USP and the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and dye pigments as specified below: Lacosamide Tablets, USP are supplied as debossed tablets and contain the following coloring agents: 50 mg tablets: red iron oxide, black iron oxide, FD&C Blue #2/indigo carmine aluminum lake 100 mg tablets: yellow iron oxide 150 mg tablets: yellow iron oxide, red iron oxide, black iron oxide 200 mg tablets: FD&C Blue #2/indigo carmine aluminum lake. chemical-structure

Lamotrigine, USP, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as -triazine, its molecular formula is C 9 H 7 N 5 Cl 2 , and its molecular weight is 256.09 g/mol. Lamotrigine, USP is a white powder and has a pKa of 5.7. Lamotrigine, USP is slightly soluble in 0.1 N hydrochloric acid, in acetone, in methanol, and in water. The structural formula is: Lamotrigine tablets for oral suspension (chewable, dispersible tablets), 5 mg and 25 mg are supplied for oral administration. The tablets contain 5 mg (white to off-white) or 25 mg (white to off-white) of lamotrigine, USP and the following inactive ingredients: aspartame, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone K-25, sodium starch glycolate and strawberry guarana 586997 AP 0551. FDA approved dissolution test specifications differ the USP for Lamotrigine tablets for oral suspension, USP (chewable, dispersible tablets), 5 mg and 25 mg. sturcture

Leucovorin is one of several active, chemically reduced derivatives of folic acid. It is useful as an antidote to drugs which act as folic acid antagonists. Also known as folinic acid, Citrovorum factor, or 5-formyl-5,6,7,8-tetrahydrofolic acid, this compound has the chemical designation of Calcium N -[p-[[[(6 RS )-2-amino-5-formyl-5,6,7,8-tetrahydro-4-hydroxy-6-pteridinyl]methyl]amino]benzoyl]-L-glutamate (1:1). The structural formula of leucovorin calcium is: - C 20 H 21 CaN 7 O 7 M.W.=511.51 Leucovorin Calcium for Injection, USP is a sterile product indicated for intramuscular (IM) or intravenous (IV) administration and is supplied in 350 mg vial. Each 350 mg vial of Leucovorin Calcium for Injection, USP, when reconstituted with 17.5 mL of sterile diluent, contains leucovorin (as the calcium salt) 20 mg/mL. In each dosage form, one milligram of leucovorin calcium, USP contains 0.002 mmol of leucovorin and 0.002 mmol of calcium. This lyophilized product contain no preservative. The inactive ingredient is Sodium Chloride, added to adjust tonicity. Sodium hydroxide may be added for pH adjustment. pH adjusted to 7.0 to 8.5. Reconstitute with Bacteriostatic Water for Injection, which contains benzyl alcohol (see WARNINGS section), or with Sterile Water for Injection. structure

Levocetirizine dihydrochloride, USP the active component of Levocetirizine Dihydrochloride Tablets, USP is an orally active H 1 -receptor antagonist. The chemical name is (-)2-[2-[4-[(4-chlorophenyl) phenyl methyl] piperazin-1-yl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride, USP is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The empirical formula of levocetirizine dihydrochloride, USP is C 21 H 25 C1N 2 O 3 •2HCl. The molecular weight is 461.81 g/mol and the chemical structure is shown below: Levocetirizine dihydrochloride, USP is a white to off-white crystalline powder and soluble in methanol and in water. Levocetirizine Dihydrochloride Tablets, USP 5 mg are formulated as immediate release, white, oval, film-coated, biconvex tablets, one side embossed with ‘G’ break line ‘G’ and the other side plain for oral administration. Inactive ingredients are: colloidal silicon dioxide, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The film coating contains hypromellose, macrogol 400, and titanium dioxide. structure

Twenty-eight (28) brownish peach to light brown tablets each containing 0.09 mg of levonorgestrel, USP (18, 19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-(-) (-)-13-Ethyl –hydroxy-18, 19 dinor-17α-pregn-4-en-20-yn-3-one, and 0.02 mg of ethinyl estradiol, USP, 19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, polacrilin potassium, talc, hypromellose, titanium dioxide, polyethylene glycol, iron oxide red and iron oxide yellow. image-01

Levonorgestrel and Ethinyl Estradiol Tablets, USP are an extended-cycle combination oral contraceptive consisting of 84 light blue to blue active tablets each containing 0.15 mg of levonorgestrel, USP, a synthetic progestin and 0.03 mg of ethinyl estradiol, USP, an estrogen, and 7 white to off-white inert tablets (without hormones). The structural formulas for the active components are: Levonorgestrel, USP C 21 H 28 O 2 MW: 312.45 Levonorgestrel, USP is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol, USP C 20 H 24 O 2 MW: 296.4 Ethinyl Estradiol, USP is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. • Each light blue to blue active tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, hypromellose, anhydrous lactose, talc, magnesium stearate, titanium dioxide, triacetin, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6 aluminum lake, D&C yellow no. 10 aluminum lake. • Each white to off-white inert tablet contains the following inactive ingredients: lactose monohydrate, anhydrous lactose, microcrystalline cellulose, hypromellose, polacrilin potassium, magnesium stearate. levonorgestrel eestructure

Lidocaine Ointment USP, 5% contains a local anesthetic agent and is administered topically. See INDICATIONS AND USAGE for specific uses. Lidocaine Ointment USP, 5% contains lidocaine USP, which is chemically designated as acetamide, 2-(diethylamino)- N -(2,6-dimethylphenyl)-, and has the following structural formula: Composition of lidocaine ointment USP, 5%: acetamide, 2-(diethylamino)- N -(2,6-dimethylphenyl)-, (lidocaine, USP) 5% in a water miscible ointment vehicle containing polyethylene glycols. structure

Each capsule for oral administration contains lithium carbonate, USP 150 mg, 300 mg or 600 mg and the following inactive ingredients: colloidal silicon dioxide, gelatin, sodium lauryl sulfate, talc, titanium dioxide, FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No. 10, and the imprinting ink contains shellac, propylene glycol, potassium hydroxide, and black iron oxide. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an emission line at 671 nm on the flame photometer. Lithium Carbonate, USP is a white, crystalline powder with molecular formula Li 2 CO 3 and molecular weight 73.89.

Lithium Carbonate Extended-Release Tablets, USP contain lithium carbonate, USP a white crystalline powder with molecular formula Li 2 CO 3 and molecular weight 73.89. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an emission line at 671 nm on the flame photometer. Each light pink to pink colored circular, biconvex, coated, extended-release tablet contains 300 mg of lithium carbonate, USP. This slowly dissolving film-coated tablet is designed to give lower serum lithium peak concentrations than obtained with conventional oral lithium dosage forms. Inactive ingredients consist of sodium chloride, povidone, sorbitol, sodium starch glycolate, sodium lauryl sulfate, calcium stearate, hypromellose, titanium dioxide, polyethylene glycol and iron oxide red. Product meets USP Dissolution Test 1.

Lithium Carbonate Extended-Release Tablets USP, contain lithium carbonate USP, a white, crystalline powder with molecular formula Li 2 CO 3 and molecular weight 73.89 g/mol. Lithium is an element of the alkali‑metal group with atomic number 3, atomic weight 6.94 and an emission line at 671 nm on the flame photometer. Lithium Carbonate Extended-Release Tablets USP Each off-white to pale yellow, circular, beveled edged, biconvex uncoated tablets with ‘224’ debossed on one side, ‘G’ and a break line debossed on the other side, contains lithium carbonate, 450 mg. Inactive ingredients consist of ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, sodium alginate, sodium starch glycolate and talc. Product meets USP Dissolution Test 2. Lithium Carbonate Extended-Release Tablets USP, 450 mg are designed to release a portion of the dose initially and the remainder gradually; the release pattern of the controlled release tablets reduces the variability in lithium blood levels seen with the immediate release dosage forms.

MARLISSA ® (levonorgestrel and ethinyl estradiol tablets) is a combination oral contraceptive (COC) consisting of 21 light orange to orange color MARLISSA ® (levonorgestrel and ethinyl estradiol tablets), each containing 0.15 mg of levonorgestrel, USP, a totally synthetic progestogen, and 0.03 mg of ethinyl estradiol, USP, an estrogen and 7 light pink to pink inert tablets (without hormones). The structural formulas for the active components are: Levonorgestrel, USP C 21 H 28 O 2 MW: 312.4 Levonorgestrel, USP is chemically d(-)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one Ethinyl Estradiol, USP C 20 H 24 O 2 MW: 296.4 Ethinyl Estradiol, USP is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol. Each light orange to orange color active tablet contains the following inactive ingredients: FD&C Yellow no. 6, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, povidone and talc. In addition, the film-coating contains hypromellose and macrogol. Each light pink to pink inert tablet contains the following inactive ingredients: D&C Red no. 30, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, povidone and talc. StructureLevonorgestrel.jpg StructureEE.jpg

Metronidazole Vaginal Gel is the intravaginal dosage form of the synthetic antibacterial agent, metronidazole, USP at a concentration of 0.75%. Metronidazole is a member of the imidazole class of antibacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is a 2-methyl-5-nitroimidazole-1-ethanol. It has a chemical formula of C 6 H 9 N 3 O 3 , a molecular weight of 171.15 g/mol, and has the following structure: Metronidazole Vaginal Gel is a gelled, purified water solution, containing metronidazole, USP at a concentration of 7.5 mg/g (0.75%). The gel is formulated at pH 4.0. The gel also contains carbomer 974P, edetate disodium, methylparaben, propylparaben, propylene glycol, and sodium hydroxide. Each applicator full of 5 grams of vaginal gel contains approximately 37.5 mg of metronidazole, USP. Structure.jpg

Micafungin for Injection, USP is a sterile, lyophilized product for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin) synthesized by a chemical modification of a fermentation product of Coleophoma empetri F-11899. Micafungin inhibits the synthesis of 1,3-beta-D-glucan, an integral component of the fungal cell wall. Each single-dose vial contains 50 mg micafungin (equivalent to 50.86 mg micafungin sodium) or 100 mg micafungin (equivalent to 101.73 mg micafungin sodium), 200 mg lactose monohydrate, with citric acid and/or sodium hydroxide (used for pH adjustment). Micafungin for Injection, USP must be diluted with 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP [see Dosage and Administration ( 2 )] . Following reconstitution with 0.9% Sodium Chloride Injection, USP, the resulting pH of the solution is between 5 to 7. Micafungin sodium is chemically designated as: Pneumocandin A0,1-[(4 R ,5 R )-4,5-dihydroxy- N 2 -[4-[5-[4-(pentyloxy) phenyl]-3-isoxazolyl]benzoyl]-L-ornithine]-4-[(4 S )-4-hydroxy-4-[4-hydroxy-3-(sulfooxy)phenyl]-L-threonine]-, monosodium salt. The chemical structure of micafungin sodium is: The empirical/molecular formula is C 56 H 70 N 9 NaO 23 S and the formula weight is 1292.26. Micafungin sodium is a light-sensitive, hygroscopic white powder that is freely soluble in water, isotonic sodium chloride solution, N,N-dimethylformamide and dimethylsulfoxide, slightly soluble in methyl alcohol, and practically insoluble in acetonitrile, ethyl alcohol (95%), acetone, diethyl ether and n-hexane. Structure Formula of Micafungin Sodium

Moexipril hydrochloride USP, the hydrochloride salt of moexipril, has the empirical formula C 27 H 34 N 2 O 7 •HCl and a molecular weight of 535.04. It is chemically described as [3S-[2[R*(R*)],3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]- 1,2,3,4-tetrahydro-6,7-dimethoxy-3-iso-quinolinecarboxylic acid, monohydrochloride. It is a non-sulfhydryl containing precursor of the active angiotensin-converting enzyme (ACE) inhibitor moexiprilat and its structural formula is: Moexipril hydrochloride USP is a fine white to off-white powder. It is soluble (about 10% weight-to-volume) in distilled water at room temperature. Moexipril hydrochloride tablets USP are supplied as scored, coated tablets containing 7.5 mg and 15 mg of moexipril hydrochloride USP for oral administration. In addition to the active ingredient, moexipril hydrochloride USP, the tablet core contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium oxide, magnesium stearate and povidone. The film coating contains: hypromellose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 6000, magnesium stearate, ferric oxide red, ferric oxide black and ferric oxide yellow (15 mg tablet only). structuralformula

Mometasone Furoate Cream USP, 0.1% contains mometasone furoate, USP for topical use. Mometasone furoate, USP is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate, USP is 9α,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C 27 H 30 Cl 2 O 6 , a molecular weight of 521.43 and the following structural formula: Mometasone furoate, USP is a white to off-white powder, soluble in acetone and methylene chloride. Each gram of Mometasone Furoate Cream USP, 0.1% contains: 1 mg mometasone furoate, USP in a cream base of aluminum starch octenyl succinate (Dry-Flo Plus (Pure)), hexylene glycol, phospholipon 90 H, phosphoric acid, purified water, titanium dioxide, white petrolatum, and white wax. mometasone-furoate-structure

Mometasone Furoate Ointment USP, 0.1% contains mometasone furoate, USP for topical use. Mometasone furoate, USP is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate, USP is 9α,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C 27 H 30 Cl 2 O 6 , a molecular weight of 521.43 and the following structural formula: Mometasone furoate, USP is a white or almost white powder, practically insoluble in water, freely soluble in acetone and in methylene chloride, slightly soluble in alcohol. Each gram of mometasone furoate Ointment USP, 0.1% contains: 1 mg mometasone furoate, USP in an ointment base of hexylene glycol, phosphoric acid, propylene glycol monopalmitostearate, purified water, white petrolatum, and white wax. mometasone-structure

Mometasone Furoate Topical Solution USP, 0.1% (Lotion) contains mometasone furoate, USP for topical use. Mometasone furoate, USP is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate, USP is 9α, 21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C 27 H 30 Cl 2 O 6 , a molecular weight of 521.43 g/mol and the following structural formula: Mometasone furoate, USP is a white to off-white powder soluble in acetone and methylene chloride. Each gram of Mometasone Furoate Topical Solution USP, 0.1% (Lotion) contains: 1 mg mometasone furoate, USP in a lotion base of hydroxypropyl cellulose, isopropyl alcohol (40%), propylene glycol, sodium phosphate monobasic monohydrate and purified water. Also contains phosphoric acid used to adjust the pH to approximately 4.5. chemical-structure

Mupirocin Cream USP, 2% contains the dihydrate crystalline calcium hemi-salt of the RNA synthetase inhibitor antibacterial, mupirocin. Chemically, it is (α E, 2 S ,3 R ,4 R ,5 S )-5-[(2 S ,3 S ,4 S ,5 S )-2,3-epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2 H -pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid, calcium salt (2:1), dihydrate. The molecular formula of mupirocin calcium, USP is (C 26 H 43 O 9 ) 2 Ca•2H 2 O, and the molecular weight is 1075.3 g/mol. The molecular weight of mupirocin free acid is 500.6 g/mol. The structural formula of mupirocin calcium, USP is: Figure 1. Structure of Mupirocin Cream, USP Mupirocin Cream USP is a white cream that contains 20 mg (2% w/w) of mupirocin equivalent to 21.5 mg (2.15% w/w) of mupirocin calcium, USP in an oil- and water-based emulsion. The inactive ingredients are benzyl alcohol, glycerol monostearate, mineral oil, phenoxyethanol, polyoxyl 20 cetostearyl ether, purified water and xanthan gum. Structure

Mupirocin Ointment USP, 2% contains the RNA synthetase inhibitor antibacterial, mupirocin, USP. The chemical name is ( E )-(2 S ,3 R ,4 R ,5 S )-5-[(2 S ,3 S ,4 S ,5 S )-2,3-epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4dihydroxy-β-methyl-2 H -pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin, USP is C 26 H 44 O 9 , and the molecular weight is 500.6 g/mol. The structural formula of mupirocin, USP is: Figure 1. Structure of Mupirocin, USP Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin, USP in a water-miscible ointment base (polyethylene glycol ointment, N.F.) consisting of polyethylene glycol 400 and polyethylene glycol 3350. Structure