teva pharmaceuticals usa, inc. - Medication Listings

Etodolac extended-release tablets, USP contain etodolac USP, which is a member of the pyranocarboxylic acid group of non-steroidal anti-inflammatory drugs (NSAIDs). Each tablet contains etodolac USP, for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. It is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. It has the following structural formula: C 17 H 21 NO 3 M.W. 287.37 The inactive ingredients in etodolac extended-release tablets, USP are calcium phosphate dibasic anhydrous, carbomer 934P, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium lauryl sulfate, and titanium dioxide. In addition, the following colorants are used: 400 mg tablets - D&C Yellow #10 Lake, FD&C Red #40, and FD&C Yellow #6; 500 mg tablets - D&C Yellow #10 Lake, FD&C Blue No. 2 Indigo Carmine Aluminum Lake, and iron oxide black; 600 mg tablets - FD&C Blue No. 2 Indigo Carmine Lake, iron oxide black, and iron oxide yellow. chemical structure for etodolac

Etonogestrel and ethinyl estradiol vaginal ring is a non-biodegradable, flexible, transparent, colorless to almost colorless, combination contraceptive vaginal ring containing two active components, a progestin, etonogestrel (13-ethyl-17-hydroxy-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-3-one) and an estrogen, ethinyl estradiol (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol). When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week period of use. Etonogestrel and ethinyl estradiol vaginal ring is made of ethylene vinylacetate copolymers (28% and 9% vinylacetate) and magnesium stearate and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. Etonogestrel and ethinyl estradiol vaginal ring is not made with natural rubber latex. Etonogestrel and ethinyl estradiol vaginal ring has an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. The molecular weights for etonogestrel and ethinyl estradiol are 324.46 and 296.40, respectively. The structural formulas are as follows: structural formula

Everolimus tablets are a kinase inhibitor. The chemical name of everolimus, USP is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0 4,9 ]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C 53 H 83 NO 14 and the molecular weight is 958.2. The structural formula is: Everolimus tablets for oral administration contain 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus, USP and the following inactive ingredients: butylated hydroxytoluene, crospovidone, hypromellose 2910, lactose anhydrous, lactose monohydrate, and magnesium stearate. 1

Famciclovir Tablets, USP contain famciclovir, USP, an orally administered prodrug of the antiviral agent penciclovir. Chemically, famciclovir, USP is known as 2-[2-(2-amino-9 H -purin-9-yl)ethyl]-1,3-propanediol diacetate. It is a synthetic acyclic guanine derivative and has the following structure: C 14 H 19 N 5 O 4 M.W. 321.3 Famciclovir, USP is a white to pale yellow solid. It is freely soluble in acetone and methanol, and sparingly soluble in ethanol and isopropanol. At 25°C famciclovir, USP is freely soluble (greater than 25% w/v) in water initially, but rapidly precipitates as the sparingly soluble (2% to 3% w/v) monohydrate. Famciclovir, USP is not hygroscopic below 85% relative humidity. Partition coefficients are: octanol/water (pH 4.8) P = 1.09 and octanol/phosphate buffer (pH 7.4) P = 2.08. Each white, film-coated tablet contains famciclovir, USP. The 125 mg and 250 mg tablets are round; the 500 mg tablets are capsule-shaped. Inactive ingredients consist of croscarmellose sodium, hydroxypropyl cellulose, hypromellose, polydextrose, polyethylene glycol, silicified microcrystalline cellulose, sodium starch glycolate, sodium stearyl fumarate, titanium dioxide, and triacetin. Product meets USP Dissolution Test 2. Chemical Structure for Famciclovir

The active ingredient in Famotidine Tablets USP is a histamine-2 (H 2 ) receptor antagonist. Famotidine, USP is [1-Amino-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio] propylidene] sulfamide and has the following structural formula: C 8 H 15 N 7 O 2 S 3 M.W. 337.45 Each Famotidine Tablet USP for oral administration contains either 20 mg or 40 mg of famotidine, USP and has the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized corn starch, sodium starch glycolate, talc, titanium dioxide, yellow iron oxide. In addition the 20 mg contains lactose monohydrate, red iron oxide and triacetin and the 40 mg contains FD&C blue No. 2 aluminum lake and FD&C yellow No. 6 aluminum lake. Famotidine, USP is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol. Structural Formula

Oral Transmucosal Fentanyl Citrate (OTFC) (fentanyl citrate) oral transmucosal lozenge is a solid formulation of fentanyl, an opioid agonist, intended for oral transmucosal administration. OTFC is formulated as a white to off-white solid drug matrix on a handle that is fracture resistant (ABS plastic) under normal conditions when used as directed. OTFC is designed to be dissolved slowly in the mouth to facilitate transmucosal absorption. The handle allows the OTFC unit to be removed from the mouth if signs of excessive opioid effects appear during administration. Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. The compound has the following structural formula: Inactive Ingredients: Hydrated dextrates, citric acid, dibasic sodium phosphate, artificial berry flavor, magnesium stearate, and edible glue (modified food starch and confectioner’s sugar). chemical-structure

Finasteride USP, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). Finasteride, USP is 4-azaandrost-1-ene-17-carboxamide, N -(1,1-dimethylethyl)-3-oxo-,(5α,17β)-. Its structural formula is: C 23 H 36 N 2 O 2 M.W. 372.55 Finasteride, USP is a white to off-white crystalline powder with a melting point near 250°C. It is freely soluble in chloroform and in lower alcohol solvents, but is practically insoluble in water. Finasteride tablets, USP for oral administration are film-coated tablets that contain 5 mg of finasteride, USP and the following inactive ingredients: FD&C Blue No. 2 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch, sodium lauryl sulfate, sodium starch glycolate type A potato, and titanium dioxide. Chemical Structure

Finzala ® (norethindrone acetate and ethinyl estradiol tablets USP, 1 mg/20 mcg and ferrous fumarate tablets) provide an oral contraceptive regimen consisting of 24 white active chewable tablets that contain the active ingredients, followed by 4 brown non-hormonal placebo tablets as specified below: 24 white, round, flat-faced, beveled-edge, unscored tablets each containing 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP. 4 brown, round, flat-faced, beveled-edge, unscored tablets each containing 75 mg ferrous fumarate, USP. Each white active chewable tablet also contains the following inactive ingredients: acacia, confectioner’s sugar, lactose monohydrate, magnesium stearate, maltodextrin, pregelatinized corn starch, silicon dioxide, spearmint oil, sucralose, and talc. Each brown placebo tablet contains ferrous fumarate USP, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose, povidone, sodium starch glycolate type A, silicon dioxide, spearmint oil, and sucralose. The ferrous fumarate tablets do not serve any therapeutic purpose. Ferrous fumarate tablets are not USP for dissolution and assay. The structural formula of ethinyl estradiol, USP is: C 20 H 24 O 2 MW: 296.40 The chemical name of ethinyl estradiol, USP is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. The structural formula of norethindrone acetate, USP is: C 22 H 28 O 3 MW: 340.46 The chemical name of norethindrone acetate, USP is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]. FDA approved dissolution test specifications differ from USP. 1 1

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The topical corticosteroids are intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene) bis(oxy)]-,(6α, 11β, 16α)-. It has the following structural formula: C 26 H 32 F 2 0 7 M.W. 494.5 Each gram of Fluocinonide Cream USP, 0.05% (Emulsified Base) contains: 0.5 mg fluocinonide, USP in a water-washable aqueous emollient base of stearyl alcohol, cetyl alcohol, mineral oil, propylene glycol, sorbitan monostearate, polysorbate 60, citric acid monohydrate and purified water. Each gram of Fluocinonide Cream USP, 0.05% contains: 0.5 mg fluocinonide, USP in a specially formulated cream base consisting of stearyl alcohol, polyethylene glycol 8000, propylene glycol, 1,2,6-hexanetriol and citric acid monohydrate. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophilic properties. In this formulation, the active ingredient is totally in solution. Each gram of Fluocinonide Ointment USP, 0.05% contains: 0.5 mg fluocinonide, USP in an ointment base consisting of white petrolatum, castor oil, and sorbitan sesquioleate. It provides the occlusive and emollient effects desirable in an ointment. In this formulation, the active ingredient is totally in solution. fluocinonide structure

Fluticasone Propionate/Salmeterol MDPI 55 mcg/14 mcg, 113 mcg/14 mcg and 232 mcg/14 mcg are combinations of fluticasone propionate and salmeterol. Fluticasone Propionate One active component of this product is fluticasone propionate, a corticosteroid having the chemical name S -(fluoromethyl) 6α,9-difluoro-11ß,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17ß-carbothioate, 17-propionate, and the following chemical structure: Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C 25 H 31 F 3 O 5 S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. Salmeterol Xinafoate The other active component of this product is salmeterol xinafoate, a beta 2 –adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1‑hydroxy‑2‑naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α -[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure: Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C 25 H 37 NO 4 •C 11 H 8 O 3 . It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Fluticasone Propionate/Salmeterol MDPI Fluticasone Propionate/Salmeterol MDPI is a multidose dry powder inhaler (MDPI) for oral inhalation only. It contains fluticasone propionate, salmeterol xinafoate, and lactose monohydrate (which may contain milk proteins). The opening of the mouthpiece cover meters 5.5 mg of the formulation from the device reservoir, which contains 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate, and 14 mcg of salmeterol base (equivalent to 20.3 mcg of salmeterol xinafoate). Patient inhalation through the mouthpiece causes the deagglomeration and aerosolization of the drug particles as the formulation moves through the cyclone component of the device. This is followed by dispersion into the airstream. Under standardized in vitro test conditions, the Fluticasone Propionate/Salmeterol MDPI delivers 49 mcg, 100 mcg, or 202 mcg of fluticasone propionate and 12.75 mcg of salmeterol base (equivalent to 18.5 mcg of salmeterol xinafoate), with lactose from the mouthpiece when tested at a flow rate of 85 L/min for 1.4 seconds. The amount of drug delivered to the lung will depend on patient factors such as inspiratory flow profiles. In adult subjects (N=50, aged 18 to 45 years) with asthma, mean peak inspiratory flow (PIF) through the Fluticasone Propionate/Salmeterol MDPI was 108.28 L/min (range: 70.37 to 129.24 L/min). In adolescent subjects (N=50, aged 12 to 17 years) with asthma, mean peak inspiratory flow (PIF) through the Fluticasone Propionate/Salmeterol MDPI was 106.72 L/min (range: 73.64 to 125.51 L/min). FP chem structure Salmeterol chem structure

Fluticasone propionate and salmeterol inhalation powder USP, 100 mcg/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg are combinations of fluticasone propionate, USP and salmeterol xinafoate, USP. One active component of fluticasone propionate and salmeterol inhalation powder, USP is fluticasone propionate USP, a corticosteroid having the chemical name S- (fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure: Fluticasone propionate, USP is a white powder with a molecular weight of 500.57, and the empirical formula is C 25 H 31 F 3 O 5 S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of fluticasone propionate and salmeterol inhalation powder, USP is salmeterol xinafoate USP, a beta 2 -adrenergic bronchodilator. Salmeterol xinafoate, USP is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α 1 -[[[6-(4-phenylbutoxy)hexyl]amino] methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure: Salmeterol xinafoate, USP is a white powder with a molecular weight of 603.75, and the empirical formula is C 25 H 37 NO 4 •C 11 H 8 O 3 . It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Fluticasone propionate and salmeterol inhalation powder, USP is supplied in a green plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone propionate, USP (100, 250, or 500 mcg) and micronized salmeterol xinafoate, USP salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, fluticasone propionate and salmeterol inhalation powder inhaler delivers 93, 233, and 465 mcg of fluticasone propionate, USP and 45 mcg of salmeterol base, per blister from fluticasone propionate and salmeterol inhalation powder USP, 100 mcg/50 mcg, fluticasone propionate and salmeterol inhalation powder USP, 250 mcg/50 mcg, and fluticasone propionate and salmeterol inhalation powder USP, 500 mcg/50 mcg, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV 1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile. 1 1

Fluvastatin sodium, USP is a water-soluble cholesterol lowering agent which acts through the inhibition of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase. Fluvastatin sodium, USP is [ R *, S *-( E )]-(±)-7-[3-(4-fluorophenyl)-1-(1-methylethyl)-1 H -indol-2-yl]-3,5-dihydroxy-6-heptenoic acid, monosodium salt. Its structural formula is: C 24 H 25 FNNaO 4 M.W. 433.45 This molecular entity is the first entirely synthetic HMG-CoA reductase inhibitor, and is in part structurally distinct from the fungal derivatives of this therapeutic class. Fluvastatin sodium, USP (hydrated form) is a white to pale yellow, brownish-pale yellow, or reddish-pale yellow, hygroscopic powder soluble in water, ethanol, and methanol. Fluvastatin Capsules, USP contain fluvastatin sodium, USP (hydrated form), equivalent to 20 mg or 40 mg of fluvastatin, for oral administration. Active Ingredient: fluvastatin sodium, USP (hydrated form) Inactive Ingredients: ammonium hydroxide, black iron oxide, colloidal silicon dioxide, crospovidone, gelatin, lactose monohydrate, magnesium stearate, propylene glycol, red iron oxide, shellac, titanium dioxide, and yellow iron oxide. Structural formula for fluvastatin

Fluvastatin sodium, USP inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Fluvastatin sodium, USP is [ R * , S * -( E )]-(±)-7-[3-(4-fluorophenyl)-1-(1-methylethyl)-1 H- indol-2-yl]-3,5-dihydroxy-6-heptenoic acid, monosodium salt. The structural formula is: C 24 H 25 FNNaO 4 M.W. 433.46 Fluvastatin sodium, USP (hydrated form) is a white to pale yellow, brownish-pale yellow, or reddish-pale yellow hygroscopic powder soluble in water, ethanol and methanol. Fluvastatin Sodium Extended-Release Tablets contains 84.24 mg of fluvastatin sodium, USP (hydrated form), equivalent to 80 mg of fluvastatin, for oral use. Fluvastatin sodium extended-release tablets contain the following inactive ingredients: crospovidone, hydroxyethyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol partially hydrolyzed, talc, and titanium dioxide. fluvastatin sodium structural formula

Formoterol fumarate inhalation solution is supplied as 2 mL of formoterol fumarate inhalation solution packaged in a 3 mL single-dose low-density polyethylene vial and overwrapped in a foil pouch. Each vial contains 2 mL of a clear, colorless solution composed of formoterol fumarate dihydrate, USP equivalent to 20 mcg of formoterol fumarate in an isotonic, sterile aqueous solution containing sodium chloride, water, pH adjusted to 5.0 with citric acid and sodium citrate. The active component of formoterol fumarate inhalation solution is formoterol fumarate dihydrate, USP, a racemate. Formoterol fumarate dihydrate, USP is a beta 2 -adrenergic bronchodilator. Its chemical name is (±)-2´-Hydroxy-5´-[( R * )-1-hydroxy-2-[[( R * )- p -methoxy- α -methylphenethyl]amino]ethyl]formanilide fumarate (2:1) (salt), dihydrate; its structural formula is: Formoterol fumarate dihydrate, USP has a molecular weight of 840.91 and its molecular formula is (C 19 H 24 N 2 O 4 ) 2 •C 4 H 4 O 4 •2H 2 O. Formoterol fumarate dihydrate, USP is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether. Formoterol fumarate inhalation solution does not require dilution prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors and the nebulization system used and its performance. Using the PARI-LC Plus ® nebulizer (with a facemask or mouthpiece) connected to a PRONEB ® Ultra compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 7.3 mcg (37% of label claim). The mean nebulizer flow rate was 4 LPM and the nebulization time was 9 minutes. Formoterol fumarate inhalation solution should be administered from a standard jet nebulizer at adequate flow rates via a facemask or mouthpiece. 1

Zinc acetate as the dihydrate is a salt of zinc used to inhibit the absorption of copper in patients with Wilson's disease. Its structural formula is: C 4 H 6 O 4 Zn•2H 2 O M.W. 219.51. Zinc acetate occurs as white crystals or granules, freely soluble in water and in boiling alcohol, and slightly soluble in alcohol. GALZIN ® (Zinc Acetate) Capsules contain the equivalent of 25 or 50 mg of zinc, in addition to corn starch and magnesium stearate in gelatin capsules. The 25 mg capsule shells contain titanium dioxide and the 50 mg capsule shells contain titanium dioxide, methylparaben and propylparaben. The 25 mg capsule shells contain FD&C Blue #1; the 50 mg capsule shells contain FD&C Red #40, D&C Red #28, and D&C Yellow #10. chemical structure

Glipizide and metformin hydrochloride tablets, USP contain 2 oral antihyperglycemic drugs used in the management of type 2 diabetes, glipizide, USP and metformin hydrochloride, USP. Glipizide, USP is an oral antihyperglycemic drug of the sulfonylurea class. The chemical name for glipizide, USP is 1-cyclohexyl-3-[[ p -[2-(5-methylpyrazinecarboxamido)ethyl]phenyl]sulfonyl]urea. Glipizide, USP is a whitish, odorless powder with a pK a of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. The structural formula is represented below. C 21 H 27 N 5 O 4 S M.W. 445.55 Metformin hydrochloride, USP is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride, USP ( N , N- dimethylimidodicarbonimidic diamide monohydrochloride) is not chemically or pharmacologically related to sulfonylureas, thiazolidinediones, or α-glucosidase inhibitors. It is a white to off-white crystalline compound. Metformin hydrochloride, USP is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK a of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride, USP is 6.68. The structural formula is as shown: C 4 H 12 ClN 5 M.W. 165.63 Glipizide and metformin hydrochloride tablets, USP for oral administration contain 2.5 mg glipizide, USP with 250 mg metformin hydrochloride, USP, 2.5 mg glipizide, USP with 500 mg metformin hydrochloride, USP, and 5 mg glipizide, USP with 500 mg metformin hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, povidone, talc, and titanium dioxide. Additionally, 2.5 mg/250 mg and 5 mg/500 mg tablets contain iron oxide black, iron oxide red, and iron oxide yellow. The tablets are film-coated, which provides color differentiation. Structural formula for glipizide structural formula for metformin hydrochloride

Glyburide tablets, USP contain micronized (smaller particle size) glyburide, USP which is an oral blood-glucose-lowering drug of the sulfonylurea class. Glyburide, USP is a white, crystalline compound. Each tablet, for oral administration, contains 1.5 mg, 3 mg, or 6 mg of glyburide, USP. Inactive ingredients: microcrystalline cellulose, pregelatinized corn starch, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate. In addition, the 3 mg and 6 mg strengths contain FD&C Blue No. 1 Aluminum Lake and FD&C Blue No. 2 Aluminum Lake. The chemical name for glyburide, USP is 1-[[ p -[2-(5-Chloro- o -anisamido)ethyl]phenyl]sulfonyl]-3-cyclohex-ylurea. The structural formula is represented below: C 23 H 28 ClN 3 O 5 S M.W. 494.00 Glyburide Tablets, USP meet USP Dissolution Test 2. structural formula - glyburide, USP

Glyburide tablets USP contain glyburide, USP, which is an oral blood-glucose-lowering drug of the sulfonylurea class. Glyburide, USP is a white, crystalline compound. The chemical name for glyburide, USP is 1-[[p-[2-(5-chloro-o-anisamido)ethyl]phenyl]-sulfonyl]-3-cyclohexylurea. It has the following structural formula: C 23 H 28 ClN 3 O 5 S M.W. 493.99 Each tablet, for oral administration, contains 1.25 mg, 2.5 mg or 5 mg of glyburide, USP. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized corn starch, sodium starch glycolate, colloidal silicon dioxide, and magnesium stearate. In addition, the 2.5 mg contains FD&C yellow No. 6 aluminum lake and the 5 mg contains D&C yellow No. 10 aluminum lake, and FD&C blue No. 1 aluminum lake. chemical structure for glyburide

Glyburide is an oral blood-glucose-lowering drug of the sulfonylurea class. It is a white, crystalline compound, formulated as tablets of 1.25 mg, 2.5 mg, and 5 mg strengths for oral administration. Glyburide tablets USP contain the active ingredient glyburide and the following inactive ingredients: dibasic calcium phosphate USP, magnesium stearate NF, microcrystalline cellulose NF, sodium alginate NF, talc USP. Glyburide 2.5 mg tablets USP also contain FD&C Red #40 Aluminum Lake. Glyburide 5 mg tablets USP also contain FD&C Blue #1 Aluminum Lake. Chemically, Glyburide is identified as 1-[[p-[2-(5-Chloro-o-anisamido)ethyl]phenyl]sulfonyl]-3-cyclohexylurea. The CAS Registry Number is 10238-21-8. The structural formula is: The molecular weight is 493.99. The aqueous solubility of Glyburide increases with pH as a result of salt formation. Chemical Structure

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 M.W. 196.64 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°C, with decomposition. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, USP. Tablets also contain anhydrous lactose, FD&C yellow no. 6 aluminum lake, microcrystalline cellulose, sodium starch glycolate, and stearic acid. Chem structure

Hydroxychloroquine sulfate, USP is an antimalarial and antirheumatic drug, chemically described as (±)-2-[[4-[(7-Chloro-4-quinolyl) amino]pentyl] ethylamino] ethanol sulfate (1:1) (salt). Its structural formula is: C 18 H 26 ClN 3 O•H 2 SO 4 Molecular Weight: 433.95 Hydroxychloroquine sulfate, USP is a white to almost white, crystalline powder, freely soluble in water; practically insoluble in alcohol, chloroform, and ether. Hydroxychloroquine sulfate tablets, USP for oral administration contain 200 mg hydroxychloroquine sulfate, USP (equivalent to 155 mg of hydroxychloroquine) and the following inactive ingredients: dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, starch 1500 partially pregelatinized maize starch, titanium dioxide, and triacetin. 2

Hydroxyurea Capsules, USP are an antimetabolite available for oral use as capsules containing 500 mg hydroxyurea, USP. Inactive ingredients: anhydrous citric acid, black iron oxide, D&C red no. 28, D&C yellow no. 10 aluminum lake, dibasic sodium phosphate anhydrous, FD&C blue no. 1, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40, FD&C red no. 40 aluminum lake, gelatin, lactose monohydrate, magnesium stearate, propylene glycol, red iron oxide, shellac glaze, sodium lauryl sulfate, and titanium dioxide. Hydroxyurea, USP is a white to off-white crystalline powder. It is hygroscopic and freely soluble in water, but practically insoluble in alcohol. Its structural formula is: CH 4 N 2 O 2 M.W. 76.05 chemical structure

Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-( p -Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy] ethanol dihydrochloride. C 21 H 27 ClN 2 O 2 · 2HCl M.W. 447.83 Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine hydrochloride, USP. Inactive ingredients include anhydrous lactose, carnauba wax, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, titanium dioxide and triacetin. structural formula

Hydroxyzine pamoate, USP is designated chemically as 1-(p-chlorobenzhydryl) 4-[2-(2-hydroxyethoxy) ethyl] diethylenediamine salt of 1,1′-methylene bis (2 hydroxy-3-naphthalene carboxylic acid). It has the following structural formula: C 21 H 27 ClN 2 O 2 •C 23 H 16 O 6 M.W. 763.27 Hydroxyzine pamoate capsules, USP are administered in doses equivalent to 25 mg, 50 mg or 100 mg of hydroxyzine hydrochloride. In addition, each capsule contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, and pregelatinized corn starch. The 25 mg also contains anhydrous lactose. The 50 mg and 100 mg also contain lactose monohydrate. The capsule shell ingredients for the 25 mg capsule are D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 50 mg capsule shell contains D&C Red No. 33, D&C Yellow No. 10, FD&C Yellow No. 6, gelatin, and titanium dioxide. The 100 mg capsule shell contains D&C Red No. 28, D&C Red No. 33, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, gelatin, and titanium dioxide. The edible imprinting ink on the 25 mg, 50 mg and 100 mg capsules contains black iron oxide, D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, propylene glycol, and shellac glaze. Structural Formula

Icatibant is a synthetic decapeptide with five non-proteinogenic amino acids. The chemical structure of icatibant acetate is presented in Figure 1. Figure 1 Chemical Structure Chemical name: D-Arginyl-L-arginyl-L-prolyl-L[(4R)-4-hydroxyprolyl]-glycyl-L[3-(2-thienyl)alanyl]-L‑seryl-D-(1,2,3,4-tetrahydroisoquinolin-3-ylcarbonyl)-L[(3aS,7aS)-octahydroindol-2-ylcarbonyl]-L‑arginine, acetate salt Icatibant Injection is provided as a sterile, isotonic, and buffered solution of icatibant acetate in a single-dose, prefilled syringe for subcutaneous administration. Each mL of the solution contains 10 mg of icatibant (free base) which is equivalent to 11.38 mg of icatibant acetate. Each prefilled syringe delivers 3 mL of solution equivalent to a 30 mg icatibant dose. The solution is clear and colorless. The solution also contains sodium chloride (isotonicity reagent), glacial acetic acid (pH adjuster), sodium hydroxide (pH adjuster) and water for injection with a pH of approximately 5.5. The solution does not contain preservatives. Pharmacological class: Icatibant is a bradykinin B2 receptor antagonist. 1

Imatinib is a small molecule kinase inhibitor. Imatinib mesylate film-coated tablets are supplied as 100 mg and 400 mg tablets for oral administration. Each 100 mg tablet contains 119.5 mg of imatinib mesylate equivalent to 100 mg of imatinib free base. Each 400 mg tablet contains 478 mg of imatinib mesylate equivalent to 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate and its structural formula is: Imatinib mesylate is a white to off-white to brownish or yellowish powder. Its molecular formula is C 29 H 31 N 7 O • CH 4 SO 3 and its molecular weight is 589.7 g/mol. Imatinib mesylate is soluble in aqueous buffers less than or equal to pH 5.5 but is very slightly soluble to insoluble in neutral/alkaline aqueous buffers. In non-aqueous solvents, the drug substance is freely soluble to very slightly soluble in dimethyl sulfoxide, methanol, and ethanol, but is insoluble in n-octanol, acetone, and acetonitrile. Inactive Ingredients: colloidal silicon dioxide anhydrous, croscarmellose sodium, crospovidone, FD&C Yellow #6 Sunset Yellow FCF aluminum lake, hydroxypropyl cellulose, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium stearyl fumarate, talc, and titanium dioxide. new

Imiquimod Cream, 3.75% is for topical administration. Each gram contains 37.5 mg of imiquimod, respectively, in a white to faintly yellow oil-in-water 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 is 1-(2-methylpropyl)-1 H -imidazol[4,5-c]quinolin-4-amine. Imiquimod has a molecular formula of C 14 H 16 N 4 and a molecular weight of 240.3. Its structural formula is: chem structure

Irbesartan and Hydrochlorothiazide Tablets USP are a combination of an angiotensin II receptor antagonist (AT 1 subtype), irbesartan, USP and a thiazide diuretic, hydrochlorothiazide (HCTZ), USP. Irbesartan, USP is a non-peptide compound, chemically described as a 2-Butyl-3-[ p -( o -1 H -tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its structural formula is: C 25 H 28 N 6 O M.W. 428.5 Irbesartan, USP is a white to off-white crystalline powder. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan, USP is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Hydrochlorothiazide, USP is 6-Chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its structural formula is: C 7 H 8 ClN 3 O 4 S 2 M.W. 297.7 Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. Hydrochlorothiazide, USP is very slightly soluble in water and freely soluble in sodium hydroxide solution. Irbesartan and Hydrochlorothiazide Tablets USP are available for oral administration in film-coated tablets containing either 150 mg or 300 mg of irbesartan, USP combined with 12.5 mg of hydrochlorothiazide, USP. Inactive ingredients include: colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, povidone, pregelatinized corn starch and titanium dioxide. image 1 image 2

Isoniazid, USP is an antibacterial available as 100 mg and 300 mg tablets for oral administration. Each tablet also contains as inactive ingredients: colloidal silicon dioxide, crospovidone, hydrogenated vegetable oil, microcrystalline cellulose, pregelatinized corn starch and talc. Isoniazid, USP is chemically known as isonicotinyl hydrazine or isonicotinic acid hydrazide. It has the following structural formula: C 6 H 7 N 3 O M.W. 137.14 Isoniazid, USP is odorless, and occurs as a colorless or white crystalline powder or as white crystals. It is freely soluble in water, sparingly soluble in alcohol and slightly soluble in chloroform and in ether. Isoniazid, USP is slowly affected by exposure to air and light. Isoniazid Structure

Isradipine is a calcium antagonist available for oral administration in capsules containing 2.5 mg or 5 mg. The structural formula of isradipine is: Chemically, isradipine is 3,5-Pyridinedicarboxylic acid, 4-(4-benzofurazanyl)-1,4-dihydro-2,6-dimethyl-, methyl 1-methylethyl ester. Isradipine is a yellow, fine crystalline powder which is odorless or has a faint characteristic odor. Isradipine is practically insoluble in water (<10 mg/L at 37ºC), but is soluble in ethanol and freely soluble in acetone, chloroform and methylene chloride. Active Ingredient: isradipine Inactive Ingredients: colloidal silicon dioxide, red iron oxide (2.5 mg capsule only), yellow iron oxide, gelatin, anhydrous lactose, magnesium stearate, sodium lauryl sulfate, starch (corn), titanium dioxide, black ink: black iron oxide, shellac, potassium hydroxide and propylene glycol. formula

Jinteli ® (norethindrone acetate and ethinyl estradiol tablets, USP) are a continuous dosage regimen of a progestin-estrogen combination for oral administration. Each white tablet contains 1 mg norethindrone acetate, USP [19-Norpregn-4-en-20-yn-3-one,7(acetyloxy)-, (17α)-] and 5 mcg ethinyl estradiol, USP [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. Each tablet also contains the following inactive ingredients: calcium stearate, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate. The structural formulas are as follows: Norethindrone Acetate, USP Ethinyl Estradiol, USP C 22 H 28 O 3 M.W. 340.46 C 20 H 24 O 2 M.W. 296.40 new

JOLESSA (levonorgestrel and ethinyl estradiol tablets) is an extended-cycle combination oral contraceptive consisting of 84 pink active tablets each containing 0.15 mg of levonorgestrel, a synthetic progestin and 0.03 mg of ethinyl estradiol, an estrogen, and 7 white inert tablets (without hormones). The structural formulas for the active components are: Levonorgestrel C 21 H 28 O 2 MW: 312.4 Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol C 20 H 24 O 2 MW: 296.4 Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Each pink active tablet contains the following inactive ingredients: anhydrous lactose NF, FD&C blue no. 1, FD&C red no. 40, hydroxypropyl methylcellulose USP, microcrystalline cellulose NF, polyethylene glycol NF, magnesium stearate NF, polysorbate 80 NF, and titanium dioxide USP. Each white inert tablet contains the following inactive ingredients: anhydrous lactose NF, hydroxypropyl methylcellulose USP, microcrystalline cellulose NF, and magnesium stearate NF. levonorgestrel ethinyl estradiol

Junel ® 21 and Junel ® Fe 28 are progestogen-estrogen combinations. Junel ® Fe 1/20 and 1.5/30: Each 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 yellow tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 20 mcg. Each light yellow tablet contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each pink tablet contains norethindrone acetate, USP (17α-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl estradiol, USP (17α-ethinyl-1,3,5(10)-estratriene-3, 17β-diol), 30 mcg. Each pink tablet contains the following inactive ingredients: acacia, compressible sugar, FD&C red no. 40 aluminum lake HT, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each brown tablet contains the following ingredients: crospovidone, ferrous fumarate, hydrogenated vegetable oil, NF Type I and microcrystalline cellulose. Norethindrone Acetate, USP C 22 H 28 O 3 M.W. 340.46 Ethinyl Estradiol, USP C 20 H 24 O 2 M.W. 296.40 Norethindrone Acetate, USP Structural Formula Ethinyl Estradiol, USP Structural Formula

Junel ® Fe 24 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets) 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 inert tablets containing ferrous fumarate, which serve no therapeutic purpose. Each active light yellow tablet contains 1 mg norethindrone acetate, USP and 0.02 mg ethinyl estradiol, USP. Each light yellow tablet also contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch. Each inert brown tablet contains 75 mg ferrous fumarate, crospovidone, hydrogenated vegetable oil and microcrystalline cellulose. The ferrous fumarate tablets do not serve any therapeutic purpose. Ferrous fumarate tablets are not USP for dissolution and assay. The chemical name of ethinyl estradiol, USP is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol, and the structural formula is: C 20 H 24 O 2 M.W. 296.40 The chemical name of norethindrone acetate, USP is 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one acetate, and the structural formula is: C 22 H 28 O 3 M.W. 340.46 ethinyl estradiol image norethindrone acetate image

Kariva ® (desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP) provides an oral contraceptive regimen of 21 white, round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol), 0.02 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive ingredients which include colloidal silicon dioxide, hypromellose, lactose monohydrate, polyethylene glycol, povidone, pregelatinized corn starch, stearic acid, and vitamin E, followed by 2 inert light-green, round tablets with the following inactive ingredients: FD&C blue no. 1 aluminum lake, FD&C yellow no. 6 aluminum lake, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch. Kariva ® also contains 5 light-blue, round tablets containing 0.01 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol) and inactive ingredients which include colloidal silicon dioxide, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, hypromellose, lactose monohydrate, polydextrose, polyethylene glycol, povidone, pregelatinized corn starch, stearic acid, titanium dioxide, triacetin and vitamin E. The structural formulas are as follows: DESOGESTREL C 22 H 30 O M.W. 310.48 ETHINYL ESTRADIOL, USP C 20 H 24 O 2 M.W. 296.40 The 21 white tablets meet USP Dissolution Test 2. 1 Ethinyl Estradiol, USP

Kelnor ® 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP): Each light yellow tablet contains 1 mg of ethynodiol diacetate, USP and 35 mcg of ethinyl estradiol, USP. The inactive ingredients include anhydrous lactose, D&C yellow no. 10 aluminum lake, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and povidone. Each white tablet is a placebo containing only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The chemical name for ethynodiol diacetate, USP is 19-nor-17α-pregn-4-en-20-yne-3β, 17-diol diacetate, and for ethinyl estradiol, USP it is 19-nor-17α-pregna-1, 3, 5 (10)-trien-20-yne-3, 17-diol. The structural formulas are as follows: Ethynodiol Diacetate, USP C 24 H 32 O 4 M.W. 384.51 Ethinyl Estradiol, USP C 20 H 24 O 2 M.W. 296.40 Ethynodiol Diacetate structural formula Ethinyl Estradiol structural formula

Kelnor ® 1/50 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP). Each pink tablet contains 1 mg of ethynodiol diacetate, USP and 50 mcg of ethinyl estradiol, USP and the inactive ingredients include anhydrous lactose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, and povidone. In addition, the coloring agents are D&C Red No. 30 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake. Each white tablet in the Kelnor 1/50 package is a placebo containing no active ingredients, and the inactive ingredients include anhydrous lactose, magnesium stearate and microcrystalline cellulose. The chemical name for ethynodiol diacetate, USP is 19-nor-17α-pregn-4-en-20-yne-3β, 17-diol diacetate, and for ethinyl estradiol, USP it is 19-nor-17α-pregna-1, 3, 5 (10)-trien-20-yne-3, 17-diol. The structural formulas are as follows: Ethynodiol Diacetate, USP C 24 H 32 O 4 M.W. 384.51 Ethinyl Estradiol, USP C 20 H 24 O 2 M.W. 296.40 Therapeutic class: Oral contraceptive. Ethynodiol Diacetate Structure Formula Ethinyl Estradiol structural formula

Ketoconazole Cream, 2% contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%. Each gram, for topical administration, contains ketoconazole 20 mg and is formulated in an aqueous cream vehicle consisting of propylene glycol, purified water, cetyl alcohol, stearyl alcohol, isopropyl myristate, sorbitan monostearate, polysorbate 60, polysorbate 80, and sodium sulfite, anhydrous: Ketoconazole is cis -1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1 H -imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine and has the following structural formula: C 26 H 28 Cl 2 N 4 O 4 M.W. 531.44 new

Ketorolac tromethamine tablets, USP are a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine, USP is (±)-5-benzoyl-2,3-dihydro-1 H -pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). The structural formula is: C 15 H 13 NO 3 . C 4 H 11 NO 3 M.W. 376.40 Ketorolac tromethamine, USP is a racemic mixture of [-]S and [+]R ketorolac tromethamine, USP. Ketorolac tromethamine, USP may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine, USP has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. Ketorolac tromethamine tablets, USP are white, round, convex, unscored, film-coated tablets. Each tablet, for oral administration, contains 10 mg ketorolac tromethamine, USP, the active ingredient. In addition, each tablet contains the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. ketorolac tromethamine structural formula

The active ingredient in Lansoprazole Delayed-Release Orally Disintegrating Tablets is lansoprazole USP, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C 16 H 14 F 3 N 3 O 2 S with a molecular weight of 369.36. Lansoprazole, USP has the following structure: Lansoprazole, USP is a white to brownish crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole, USP is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole, USP is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole, USP is supplied in a Delayed-Release Orally Disintegrating Tablet for oral administration. Lansoprazole Delayed-Release Orally Disintegrating Tablets are available in two dosage strengths: 15 mg and 30 mg of lansoprazole, USP per tablet. Each delayed-release orally disintegrating tablet contains enteric-coated pellets consisting of 15 mg or 30 mg of lansoprazole, USP (active ingredient) and the following inactive ingredients: aspartame*, crospovidone, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium carbonate, magnesium stearate, maize starch, methacrylic acid copolymer type c, microcrystalline cellulose, strawberry flavor (cis-3-hexan-1-ol, cis-3-hexen-1-yl acetate, cis-3-hexenyl butyrate, cis-3-hexenyl hexanoate, ethyl butyrate, ethyl isovalerate, ethyl valerate, ethyl-2-methylbutyrate, gamma-decalactone, hexyl hexanoate, gum arabic, lactose, maltodextrin, methyl cinnamate, triethyl citrate), talc, titanium dioxide, and triethyl citrate. * Phenylketonurics: Contains Phenylalanine 4.05 mg per 15 mg Tablet and 8.11 mg per 30 mg Tablet. Chemical Structure

The active ingredient in lansoprazole delayed-release capsules, USP is lansoprazole, USP, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Lansoprazole, USP has the following structure: C 16 H 14 F 3 N 3 O 2 S M.W. 369.36 Lansoprazole, USP is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole, USP is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole, USP is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5 and approximately 18 hours at pH 7. The lansoprazole delayed-release capsules, USP for oral administration are available in two dosage strengths: 15 mg and 30 mg of lansoprazole, USP per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole, USP (active ingredient) and the following inactive ingredients: black iron oxide, gelatin, hypromellose, magnesium carbonate, methacrylic acid copolymer dispersion, propylene glycol, red iron oxide, shellac, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. Additionally, 15 mg capsule contains brilliant blue FCF - FD&C blue 1. structure

Lanthanum carbonate chewable tablets contain lanthanum carbonate with molecular formula La 2 (CO 3 ) 3 xH 2 O (on average x=4 to 5 moles of water) and molecular weight 457.8 (anhydrous mass). Lanthanum carbonate is described as white to almost-white powder. Lanthanum carbonate is practically insoluble in water and is insoluble in organic solvents; it dissolves in dilute mineral acids with effervescence. Each white to off-white, lanthanum carbonate chewable tablet contains lanthanum carbonate hydrate equivalent to 500 mg, 750 mg, or 1,000 mg of elemental lanthanum and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dextrates (hydrated), and magnesium stearate.

Each cycle of Lessina ® 28 (levonorgestrel and ethinyl estradiol tablets USP) consists of 21 pink active tablets each containing 0.1 mg levonorgestrel, USP and 0.02 mg ethinyl estradiol, USP; and seven white inert tablets. The inactive ingredients include anhydrous lactose, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, corn starch, and titanium dioxide. Each white tablet contains only inert ingredients as follows: anhydrous lactose, hypromellose, microcrystalline cellulose, and magnesium stearate. The structural formulas are as follows: Levonorgestrel, USP C 21 H 28 O 2 Molecular Weight: 312.4 Ethinyl Estradiol, USP C 20 H 24 O 2 Molecular Weight: 296.4 levonorgestrel structural formula ethinyl estradiol

Letrozole tablets, USP for oral administration contain 2.5 mg of letrozole USP, a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis). It is chemically described as 4,4'-(1 H -1,2,4-triazol-1-ylmethylene)dibenzonitrile, and its structural formula is: C 17 H 11 N 5 M.W. 285.31 Letrozole, USP is a white to yellowish fine powder, freely soluble in dichloromethane, slightly soluble in ethanol, and practically insoluble in water. It has a melting range of 184° to 185°C. Letrozole tablets, USP are available as 2.5 mg tablets for oral administration. Inactive Ingredients: colloidal silicon dioxide, FD&C blue #2 aluminum lake, FD&C yellow #5 aluminum lake, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, corn starch, talc, and titanium dioxide. Sturctural Formula of Letrozole

Leucovorin calcium tablets, USP contain either 5 mg or 25 mg leucovorin as the calcium salt of N -[4-[[(2-amino-5-formyl-1, 4, 5, 6, 7, 8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]- L -glutamic acid. This is equivalent to 5.4 mg or 27.01 mg of anhydrous leucovorin calcium, respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The 25 mg tablet also contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake. Leucovorin is a water soluble form of reduced folate in the folate group; it is useful as an antidote to drugs which act as folic acid antagonists. These tablets are intended for oral administration only. The structural formula is as follows: C 20 H 21 CaN 7 O 7 M.W. 511.5 structural formula

Levalbuterol Inhalation Solution USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta 2 -adrenergic receptor agonist [see Clinical Pharmacology (12) ]. The chemical name for levalbuterol HCl is (R)-α 1 -[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows: The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C 13 H 21 NO 3 •HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 188°C and is soluble in water and slightly soluble in ethanol. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. Levalbuterol Inhalation Solution USP is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg (0.0103%) of levalbuterol (as 0.36 mg of levalbuterol HCl) or 0.63 mg (0.021%) of levalbuterol (as 0.73 mg of levalbuterol HCl) or 1.25 mg (0.042%) of levalbuterol (as 1.44 mg of levalbuterol HCl), sodium chloride to adjust tonicity, 0.33 mg of edetate disodium dihydrate, 6 mg of trisodium citrate dihydrate and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5). chemical structure

Levocetirizine dihydrochloride, USP, the active component of Levocetirizine Dihydrochloride Tablets USP, is an orally active H 1 -receptor antagonist. The chemical name is R-(+)-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 chemical structure is shown below: C 21 H 25 ClN 2 O 3 •2HCl M.W. 461.8 Levocetirizine dihydrochloride, USP is a white or almost white powder and is freely soluble in water, practically insoluble in acetone and in methylene chloride. Levocetirizine dihydrochloride tablets USP, 5 mg are formulated as immediate-release white to off-white, film-coated, oval-shaped, scored tablets for oral administration. One side of the tablet is scored in half and debossed with the number "9" on one side of the score and "3" on the other. The other side of the tablet is debossed with the number "7701." Inactive ingredients are: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. levocetirizine dihydrochloride structural formula

Liothyronine Sodium Tablets USP contains the active ingredient, liothyronine (L-triiodothyronine or LT3), a synthetic form of a thyroid hormone liothyronine in sodium salt form. It is chemically designated as L-Tyrosine, O -(4-hydroxy-3-iodophenyl)-3,5-diiodo-, monosodium salt. The molecular formula, molecular weight and structural formula of liothyronine sodium, USP are given below. C 15 H 11 I 3 NNaO 4 MW 672.96 Liothyronine Sodium Tablets USP contains liothyronine sodium, USP equivalent to liothyronine in 5 mcg, 25 mcg, and 50 mcg. Inactive ingredients consist of corn starch (pregelatinized), edetate disodium, magnesium stearate, and microcrystalline cellulose. structure

Liraglutide injection contains liraglutide, an analog of human GLP-1 and acts as a GLP-1 receptor agonist. The peptide precursor of liraglutide, produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae, has been engineered to be 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34. Liraglutide is made by attaching a C-16 fatty acid (palmitic acid) with a glutamic acid spacer on the remaining lysine residue at position 26 of the peptide precursor. The molecular formula of liraglutide is C 172 H 265 N 43 O 51 and the molecular weight is 3751.2 Daltons. The structural formula ( Figure 1 ) is: Figure 1. Structural Formula of Liraglutide Liraglutide injection is a sterile, aqueous, clear, colorless or almost colorless solution for subcutaneous use. Each 1 mL of liraglutide injection solution contains 6 mg of liraglutide and the following inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection. Liraglutide injection has a pH of approximately 8.15, hydrochloric acid or sodium hydroxide may be added to adjust pH. Each prefilled pen contains a 3 mL solution of liraglutide equivalent to 18 mg liraglutide (free-base, anhydrous). figure-1

Loperamide hydrochloride is a white to slightly yellow powder and is freely soluble in methanol, isopropyl alcohol, chloroform and slightly soluble in water. Loperamide hydrochloride, 4-(p-chlorophenyl)-4-hydroxy-N,N-dimethyl-α,α-diphenyl-1-piperidinebutyramide monohydrochloride, is a synthetic antidiarrheal for oral use. Its structural formula is: C 29 H 33 ClN 2 O 2 •HCl M.W. 513.51 Loperamide hydrochloride is available in 2 mg capsules. The inactive ingredients: dimethylpolysiloxane, gelatin, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, pregelatinized corn starch, magnesium stearate, shellac, and titanium dioxide. Structural formula for loperaminde hydrochloride