teva pharmaceuticals usa, inc. - Medication Listings

CAMRESE (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) is an extended-cycle oral contraceptive consisting of 84 light blue-green tablets each containing 0.15 mg of levonorgestrel, a synthetic progestogen and 0.03 mg of ethinyl estradiol, and 7 yellow tablets containing 0.01 mg of ethinyl estradiol. 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 light blue-green tablet contains the following inactive ingredients : anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6/Sunset yellow aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. Each yellow tablet contains the following inactive ingredients : anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6/Sunset yellow aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide. Levonorgestrel Structural Formula Ethinyl Estradiol Structural Formula

CAMRESE LO (levonorgestrel/ethinyl estradiol and ethinyl estradiol tablets) is an extended-cycle oral contraceptive regimen of 84 orange tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, followed by 7 yellow tablets each containing 0.01 mg ethinyl estradiol. 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)-. Inactive ingredients for the orange tablets: FD&C Yellow # 6 (Sunset Yellow) aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, corn starch, titanium dioxide and triacetin. Inactive ingredients for the yellow tablets: anhydrous lactose, FD&C Yellow # 10 aluminum lake, FD&C Yellow # 6 (Sunset Yellow) aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide. Structural formula of levonorgestrel Structural formula of ethinyl estradiol

Capecitabine, USP is a nucleoside metabolic inhibitor. The chemical name is 5’-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine and has a molecular formula of C 15 H 22 FN 3 O 6 and a molecular weight of 359.35. Capecitabine, USP has the following structural formula: Capecitabine, USP is a white to off-white crystalline powder with an aqueous solubility of 26 mg/mL at 20°C. Capecitabine tablets, USP are supplied as oblong, film-coated, biconvex, unscored tablets for oral administration. Each peach to light peach-colored tablet contains 150 mg or 500 mg capecitabine, USP. The inactive ingredients are as follows: anhydrous lactose, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, talc, titanium dioxide, and yellow iron oxide. 1

Carbamazepine USP is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as chewable tablets of 100 mg and tablets of 200 mg. Its chemical name is 5 H -dibenz[ b,f ]azepine-5-carboxamide, and its structural formula is: C 15 H 12 N 2 O M.W. 236.27 Carbamazepine, USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Carbamazepine Tablets, USP 200 mg contain the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, ethylcellulose, glycerin, lactose monohydrate, magnesium stearate, and sodium starch glycolate. Carbamazepine Tablets, USP (chewable) 100 mg contain the inactive ingredients acacia, colloidal silicon dioxide, croscarmellose sodium, ethylcellulose, FD&C Red #40 aluminum lake, flavoring, glycerin, lactose monohydrate, magnesium stearate, pregelatinized corn starch, and sucrose. Carbamazepine Tablets, USP 200 mg meet USP Dissolution Test 3. Carbamazepine Tablets, USP (chewable) 100 mg meet USP Dissolution Test 1. Image of Carbamazepine Structural Formula

Carbidopa and levodopa tablets, USP are a combination product for the treatment of Parkinson's disease and syndrome. Carbidopa, USP an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C 10 H 14 N 2 O 4 •H 2 O, and its structural formula is: Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23. Levodopa, USP an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C 9 H 11 NO 4 , and its structural formula is: Carbidopa and Levodopa Tablets, USP for oral administration, are supplied in three strengths: 10 mg/100 mg, containing 10 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/100 mg, containing 25 mg of carbidopa, USP and 100 mg of levodopa, USP. 25 mg/250 mg, containing 25 mg of carbidopa, USP and 250 mg of levodopa, USP. In addition, each tablet contains the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize). In addition, the 25 mg/100 mg strength contain D&C yellow #10 aluminum lake and FD&C yellow #6 aluminum lake (sunset yellow lake). The 10 mg/100 mg and 25 mg/250 mg strengths contain FD&C blue #2 aluminum lake. 67944b5f-figure-01 67944b5f-figure-02

Cefaclor, USP, the active ingredient in cefaclor extended-release tablets USP, is a semisynthetic cephalosporin antibiotic for oral administration. Cefaclor, USP, is chemically designated as 3-chloro-7-D­(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. The cefaclor extended-release tablets formulation of cefaclor differs pharmacokinetically from the immediate-release formulation of cefaclor. C 15 H 14 ClN 3 O 4 S • H 2 O M.W. 385.82 Each cefaclor extended-release tablet contains cefaclor monohydrate equivalent to 500 mg (1.36 mmol) anhydrous cefaclor. In addition, each extended-release tablet contains the following inactive ingredients: FD&C Blue #2 - indigo carmine lake, hypromellose, magnesium stearate, mannitol, polyethylene glycol, povidone and titanium dioxide. cefaclor structural formula

Cefadroxil capsules, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. Cefadroxil monohydrate is a white to yellowish-white crystalline powder. It is soluble in water and it is acid-stable. It is chemically designated as 5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[amino(4-hydroxyphenyl)acetyl]amino]-3-methyl-8-oxo-, monohydrate, [6 R -[6α,7β ( R *)]]-. It has the following structural formula: C 16 H 17 N 3 O 5 S•H 2 O M.W. 381.40 Cefadroxil capsules, USP contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Yellow #10 Aluminum Lake, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40, FD&C Red #40 Aluminum Lake, gelatin, iron oxide black, magnesium stearate, propylene glycol, shellac glaze, sodium lauryl sulfate, and titanium dioxide. Chemical Structure

Cefadroxil, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is a white to off-white crystalline powder. It is soluble in water and it is acid-stable. It is chemically designated as (6 R ,7 R )-7-[( R )-2-amino-2-( p -hydroxyphenyl)acetamido]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate. It has the following structural formula: C 16 H 17 N 3 O 5 S•H 2 O M.W. 381.40 Cefadroxil tablets, USP are available in a 1,000 mg strength and contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. Cefadroxil chemical structure

Cefdinir for oral suspension, USP contains the active ingredient cefdinir monohydrate, USP, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir monohydrate, USP is (6 R ,7 R )-7-[[(2Z)-(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate. Cefdinir monohydrate, USP is a white to light yellow crystalline powder. Its solubility is 19.56 mg/mL in 0.1 M pH 7 phosphate buffer. Cefdinir monohydrate, USP has the structural formula shown below: C 14 H 13 N 5 O 5 S 2 •H 2 O M.W. 413.44 Cefdinir for oral suspension, USP, after reconstitution, contains 125 mg or 250 mg cefdinir per 5 mL and the following inactive ingredients: artificial cherry-mixed fruit flavor, anhydrous citric acid, colloidal silicon dioxide, guar gum, magnesium stearate, sodium benzoate, sodium citrate (anhydrous), sucrose, and xanthan gum. Structural formula for cedfinir monohydrate

Cefdinir Capsules USP contain the active ingredient cefdinir, USP an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is (6 R ,7 R )-7-[[(2Z)-(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Cefdinir,USP is a white to light yellow crystalline powder. Its solubility is 19.56 mg/mL in 0.1 M pH 7.0 phosphate buffer. Cefdinir has the structural formula shown below: C 14 H 13 N 5 O 5 S 2 M.W. 395.41 Cefdinir Capsules USP contain 300 mg cefdinir, USP and the following inactive ingredients: carboxymethylcellulose calcium, colloidal silicon dioxide, croscarmellose sodium, D&C red #28, D&C yellow #10, D&C yellow #10 aluminum lake, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C green #3, FD&C red #40, FD&C red #40 aluminum lake, gelatin, iron oxide black, magnesium stearate, polyoxyl 40 stearate, propylene glycol, shellac glaze, sodium lauryl sulfate, and titanium dioxide. Chemical Structure for cefdinir

Cefprozil, USP is a semi-synthetic broad-spectrum cephalosporin antibiotic. Cefprozil, USP is a cis and trans isomeric mixture (≥ 90% cis). The chemical name for the monohydrate is (6 R ,7 R )-7-[( R )-2-amino-2-(p-hydroxyphenyl)acetamido]-8-oxo-3-propenyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate, and the structural formula is: C 18 H 19 N 3 O 5 S•H 2 O M.W. 407.45 Cefprozil, USP is a white to yellowish powder. Cefprozil Tablets USP are intended for oral administration. Cefprozil Tablets USP contain cefprozil, USP equivalent to 250 mg or 500 mg of anhydrous cefprozil. In addition, each tablet contains the following inactive ingredients: hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide. The 250 mg tablets also contain D&C Yellow No. 10 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, and FD&C Yellow No. 6 Aluminum Lake. Structural formula for cefprozil.

Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid, monohydrate. Cephalexin, USP has the following structural formula: C 16 H 17 N 3 O 4 S•H 2 O M.W. 365.41 The nucleus of cephalexin, USP is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin, USP in water is approximately 4.5 to 5. The crystalline form of cephalexin, USP which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin, USP has a D -phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin monohydrate, USP equivalent to 250 mg (720 μmol) or 500 mg (1,439 μmol) of cephalexin. Inactive Ingredients: CAPSULES: magnesium stearate, silicon dioxide, and sodium starch glycolate. Capsule Shell and Print Constituents: black iron oxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, gelatin, pharmaceutical glaze modified in SD-45, silicon dioxide or carboxymethylcellulose sodium, sodium lauryl sulfate, titanium dioxide and may contain propylene glycol. In addition, the 250 mg capsule shell contains yellow iron oxide. After mixing, each 5 mL of cephalexin for oral suspension USP will contain cephalexin monohydrate, USP equivalent to 125 mg (360 μmol) or 250 mg (720 μmol) of cephalexin. Inactive Ingredients: SUSPENSION: FD&C Red #40, cherry mixed fruit flavor (artificial flavors, benzyl alcohol, maltodextrin, and modified corn starch), silicon dioxide, sodium benzoate, sugar (fruit granulated), and xanthan gum. structure

Cephalexin tablets, USP contain the active ingredient cephalexin, which is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α- amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid, monohydrate. Cephalexin, USP has the molecular formula C 16 H 17 N 3 O 4 S•H 2 O and the molecular weight is 365.40. Cephalexin, USP has the following structural formula: The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin, USP has a D -phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each tablet contains cephalexin monohydrate equivalent to 250 mg or 500 mg of cephalexin. The tablets also contain magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. In addition, the 250 mg contains hypromellose and polysorbate 80. The 500 mg contains polyvinyl alcohol-part hydrolyzed and talc. cephalexin structural formula

Chlordiazepoxide hydrochloride, USP is the prototype for the benzodiazepine compounds. It is a versatile therapeutic agent of proven value for the relief of anxiety. Chlordiazepoxide hydrochloride, USP is among the safer of the effective psychopharmacologic compounds available, as demonstrated by extensive clinical evidence. Chlordiazepoxide hydrochloride, USP is 7-chloro-2-(methylamino)-5-phenyl-3 H -1,4-benzodiazepine 4-oxide hydrochloride. A white to practically white crystalline substance, it is soluble in water. It is unstable in solution and the powder must be protected from light. The structural formula is: C 16 H 14 ClN 3 O • HCl M.W. 336.22 Each capsule, for oral administration, contains either 5 mg, 10 mg or 25 mg of chlordiazepoxide hydrochloride, USP and has the following inactive ingredients: anhydrous lactose, D&C yellow no. 10, FD&C blue no. 1, gelatin, hydrogenated vegetable oil, microcrystalline cellulose, pharmaceutical glaze, and titanium dioxide. The 5 mg and 25 mg also contain 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, and synthetic black iron oxide. In addition, the 5 mg contains D&C red no. 33 and the 10 mg also contains FD&C red no. 40, povidone, propylene glycol, and sodium hydroxide. The 5 mg and 25 mg may also contain propylene glycol. Chlordiazepoxide hydrochloride structural formula

Cilostazol, USP is a quinolinone derivative that inhibits cellular phosphodiesterase (more specific for phosphodiesterase III). Cilostazol, USP is 6-[4-(1-cyclohexyl-1 H -tetrazol-5-yl)butoxy]-3,4-dihydro-2(1 H )-quinolinone, CAS-73963-72-1. The structural formula is: C 20 H 27 N 5 O 2 M.W. 369.46 Cilostazol, USP occurs as white to off-white crystals or as a crystalline powder that is slightly soluble in methanol and ethanol, and is practically insoluble in water, 0.1 N HCl, and 0.1 N NaOH. Cilostazol tablets, USP for oral administration are available in 50 mg pillow-shaped and 100 mg round, white to off-white debossed tablets. Each tablet, in addition to the active ingredient, contains the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, magnesium stearate, microcrystalline cellulose, and povidone. Meets USP Dissolution Test 3. Chemical Structure for Cilostazol

Cimetidine is a histamine H 2 -receptor antagonist. Chemically it is N” -cyano- N -methyl- N’ -[2-[[(5-methyl-1 H -imidazol-4-yl)methyl]thio]-ethyl], guanidine. The molecular formula for cimetidine is C 10 H 16 N 6 S; and the molecular weight is 252.35. The structural formula for cimetidine is: Cimetidine contains an imidazole ring, and is chemically related to histamine. Cimetidine has a bitter taste and characteristic odor. 1 Solubility Characteristics Cimetidine is soluble in alcohol, slightly soluble in water, very slightly soluble in chloroform and insoluble in ether. Each tablet, for oral administration, contains 300 mg, 400 mg, or 800 mg cimetidine, USP. In addition, each tablet contains the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and sodium starch glycolate. The coating for the tablets contains: carnauba wax, hypromellose, polyethylene glycol, polysorbate 80, talc, titanium dioxide, and triethyl citrate. The coating for the 300 mg and 400 mg tablets also contains D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, and FD&C Yellow No. 6 Aluminum Lake.

Isotretinoin, USP a retinoid, is available as Claravis ™ (isotretinoin capsules USP), in 10 mg, 20 mg, 30 mg and 40 mg hard gelatin capsules for oral administration. Chemically, isotretinoin is 13- cis -retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder. The structural formula is: C 20 H 28 O 2 Molecular Weight: 300.44 Each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium, gelatin, hydrogenated vegetable oil, polysorbate 80, soybean oil, titanium dioxide, white wax (beeswax), and vitamin E. In addition, the 10 mg capsule contains black iron oxide and FD&C yellow no. 6. The 20 mg capsule contains black iron oxide, red iron oxide and yellow iron oxide. The 30 mg capsule contains red iron oxide and yellow iron oxide. The 40 mg capsule contains FD&C yellow no. 6. The edible imprinting ink contains: 10 mg strength, D&C red no. 7 calcium lake, FD&C yellow no. 6 aluminum lake, propylene glycol, shellac glaze, and titanium dioxide; 20 mg strength, ammonium hydroxide, propylene glycol, shellac glaze, simethicone and titanium dioxide; 30 mg strength, 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, iron oxide black, propylene glycol, and shellac glaze; 40 mg strength, ammonium hydroxide, iron oxide black, propylene glycol, and shellac glaze. Meets dissolution test 2. Chemical Structure

Clemastine belongs to the benzhydryl ether group of antihistaminic compounds. The chemical name is (+)-(2 R )-2-[2-[[( R )- p -Chloro-α-methyl-α-phenylbenzyl]-oxy]ethyl]-1-methylpyrrolidine fumarate (1:1). C 21 H 26 C1NO . C 4 H 4 O 4 M.W. 459.97 Each tablet for oral administration contains 2.68 mg of clemastine fumarate, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, povidone, pregelatinized starch and stearic acid. chemical structure for clemastine

Each tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg of clonazepam USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP, 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP, 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, clonazepam, USP is 5-( o -chlorophenyl)-1,3-dihydro-7-nitro-2 H -1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C 15 H 10 ClN 3 O 3 M.W. 315.72 chem structure

Clonazepam orally disintegrating tablets, USP a benzodiazepine, contains 0.125 mg, 0.25 mg, 0.5 mg, 1 mg or 2 mg clonazepam, USP. Each orally disintegrating tablet also contains the following inactive ingredients: aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, sodium stearyl fumarate, strawberry flavor and xylitol. Chemically, clonazepam, USP is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2 H -1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C 15 H 10 CIN 3 O 3 M.W. 315.72 Molecular Structure

Clozapine, USP an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5 H -dibenzo [ b , e ] [1,4] diazepine. The structural formula is: C 18 H 19 CIN 4 M.W. 326.82 Clozapine Orally Disintegrating Tablets (referred to as Clozapine ODT) is available as yellow, orally disintegrating tablets of 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg for oral administration without water. Clozapine Orally Disintegrating Tablets may be chewed. Each orally disintegrating tablet contains clozapine, USP, equivalent to 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. The active component of Clozapine Orally Disintegrating Tablets is clozapine, USP. Inactive ingredients include aspartame powder, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate and xylitol. Clozapine ODT contains aspartame [ see Warnings and Precautions (5.18)] . Phenylalanine is a component of aspartame. Each 12.5 mg, orally disintegrating tablet contains 2.5 mg aspartame, thus, 1.4 mg phenylalanine. Each 25 mg, orally disintegrating tablet contains 5 mg aspartame, thus, 2.8 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 20 mg aspartame, thus, 11.2 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 30 mg aspartame, thus, 16.8 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 40 mg aspartame, thus, 22.4 mg phenylalanine. 1

The active ingredient of cromolyn sodium inhalation solution, USP is cromolyn sodium, USP. It is an inhaled anti-inflammatory agent for the preventive management of asthma. Cromolyn sodium, USP is chemically designated as disodium 5,5'- [(2-hydroxytrimethylene)dioxy] bis [4-oxo-4 H -1-benzopyran-2-carboxylate]. The molecular formula is C 23 H 14 Na 2 O 11 ; the molecular weight is 512.34. Cromolyn sodium, USP is a water-soluble, odorless, white, hydrated crystalline powder. It is tasteless at first, but leaves a slightly bitter aftertaste. Cromolyn sodium inhalation solution USP is clear, colorless to pale yellow, sterile and has a target pH of 5.5. The structural formula is: Each 2 mL vial for oral inhalation use only contains 20 mg cromolyn sodium, USP in water for injection, USP. structure

Cryselle ® is a combination oral contraceptive containing the progestational compound norgestrel, USP and the estrogenic compound ethinyl estradiol, USP. Norgestrel is designated as (2) (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each white active Cryselle tablet contains 0.3 mg norgestrel, USP and 0.03 mg ethinyl estradiol, USP. The inactive ingredients present are hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol and pregelatinized corn starch. The light-green inactive tablets also contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. Norgestrel, USP C 21 H 28 O 2 MW: 312.45 Ethinyl Estradiol, USP C 20 H 24 O 2 MW: 296.40 Norgestrel Strustural Formula Ethinyl Estradiol Structural Formula

Cyclosporine oral solution, USP MODIFIED is an oral formulation of cyclosporine, USP that immediately forms an emulsion in an aqueous environment. Cyclosporine, USP, the active principle in cyclosporine oral solution, USP MODIFIED, is a cyclic polypeptide immunosuppressant agent consisting of 11 amino acids. It is produced as a metabolite by the fungus species Tolypocladium inflatum . Chemically, cyclosporine, USP is designated as [ R -[ R *, R *-( E )]]-cyclic-(L-alanyl-D-alanyl- N -methyl-L-leucyl- N -methyl-L-leucyl- N -methyl-L-valyl-3-hydroxy- N ,4-dimethyl-L-2-amino-6-octenoyl-L-α-amino-butyryl- N -methylglycyl- N -methyl-L-leucyl-L-valyl- N -methyl-L-leucyl) and has the following structural formula: Each mL of cyclosporine oral solution, USP MODIFIED contains 100 mg/mL cyclosporine, USP and 15.3% v/v (12.18% wt/vol) dehydrated alcohol, USP and has the following inactive ingredients: polyoxyl 40 hydrogenated castor oil, polyglycerol (3) oleate and polyglycerol (10) oleate. Cyclosporine Chemical Structure

Cyclosporine capsules, USP MODIFIED are an oral formulation of cyclosporine, USP that immediately forms an emulsion in an aqueous environment. Cyclosporine, USP, the active principle in cyclosporine capsules, USP MODIFIED, is a cyclic polypeptide immunosuppressant agent consisting of 11 amino acids. It is produced as a metabolite by the fungus species Tolypocladium inflatum . Chemically, cyclosporine, USP is designated as [ R -[ R *, R *-( E )]]-cyclic-(L-alanyl-D-alanyl- N -methyl-L-leucyl- N -methyl-L-leucyl- N -methyl-L-valyl-3-hydroxy- N ,4-dimethyl-L-2-amino-6-octenoyl-L-α-amino-butyryl- N -methylglycyl- N -methyl-L-leucyl-L-valyl- N -methyl-L-leucyl) and has the following structural formula: Each soft gelatin capsule for oral administration contains either 25 mg, 50 mg or 100 mg of cyclosporine, USP MODIFIED and 15.8% v/v (12.4% wt./vol) dehydrated alcohol and has the following inactive ingredients: DL-alpha-tocopherol, gelatin, glycine, glycerol 99%, glyceryl monolinoleate, polyoxyl 40 hydrogenated castor oil, propylene glycol, sorbitol solution and titanium dioxide. In addition, the 25 mg and 50 mg contain ferric oxide (yellow) and the 100 mg contains ferric oxide (brown). structural formula

Danazol, USP is a synthetic steroid derived from ethisterone. It is a white to pale yellow crystalline powder, practically insoluble or insoluble in water, and sparingly soluble in alcohol. Chemically, danazol, USP is 17α-Pregna-2,4-dien-20-yno [2,3- d ]-isoxazol-17-ol, which has the following structural formula: C 22 H 27 NO 2 M.W. 337.46 Danazol capsules, USP for oral administration, contain 50 mg, 100 mg or 200 mg of danazol, USP. In addition, each capsule contains the following inactive ingredients: black iron oxide, D&C yellow no. 10, 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, gelatin, lactose monohydrate, magnesium stearate, pharmaceutical glaze, propylene glycol, sodium starch glycolate, stearic acid and titanium dioxide The 50 mg and 100 mg capsule shells also contain FD&C yellow no. 6. The 200 mg capsule shell also contains FD&C red no. 40 and D&C red no. 28. Structural Formula

Dexmethylphenidate hydrochloride extended-release capsules contain dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each dexmethylphenidate hydrochloride extended-release capsule contains a single type multilayered beads having half the dose as immediate-release component and half as enteric-coated, delayed-release component, thus providing an immediate-release of dexmethylphenidate and a second delayed-release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release capsules are intended for oral administration and are available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg strengths. Chemically, dexmethylphenidate hydrochloride is (2R, 2’R)-(+)-threo-methyl α-phenyl-2- piperidineacetate hydrochloride. Its structural formula is: C 14 H 19 NO 2 •HCl M.W. 269.77 Note* = asymmetric carbon center Dexmethylphenidate hydrochloride is a white crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in chloroform, sparingly soluble in ethanol, and very slightly soluble in acetone. Inactive ingredients: ammonio methacrylate copolymer, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2/indigo carmine aluminum lake, FD&C red no. 40 aluminum lake, gelatin, hypromellose, iron oxide black, methacrylic acid copolymer, non-pareil seeds (which contain corn starch and sucrose), polyethylene glycol, propylene glycol, shellac glaze, talc, titanium dioxide, and triethyl citrate. Additionally, 5 mg and 25 mg capsules contain FD&C blue no. 1; 10 mg and 30 mg capsules contain D&C yellow no. 10; 15 mg capsules contain FD&C green no. 3; 35 mg capsules contain D&C yellow no. 10 and FD&C blue no. 1; and 40 mg capsules contain FD&C blue no. 1 and FD&C green no. 3. chemical structure for dexmethylphenidate hydrochloride

A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate. EACH TABLET CONTAINS 5 mg 7.5 mg 10 mg 12.5 mg 15 mg 20 mg 30 mg Dextroamphetamine Saccharate 1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg Amphetamine Aspartate Monohydrate Equivalent 1.25 mg 1 1.875 mg 2 2.5 mg 3 3.125 mg 4 3.75 mg 5 5 mg 6 7.5 mg 7 Dextroamphetamine Sulfate, USP 1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg Amphetamine Sulfate, USP 1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg Total Amphetamine Base Equivalence 3.13 mg 4.7 mg 6.3 mg 7.8 mg 9.4 mg 12.6 mg 18.8 mg 1 1.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as supplied 2 1.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as supplied 3 2.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as supplied 4 3.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925 mg Amphetamine Aspartate (Anhydrous) as supplied 5 3.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as supplied 6 5 mg of Amphetamine Aspartate Monohydrate equivalent to 4.6 mg Amphetamine Aspartate (Anhydrous) as supplied 7 7.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as supplied In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, compressible sugar (sucrose and maltodextrin), corn starch, magnesium stearate, microcrystalline cellulose and saccharin sodium. The 5 mg, 7.5 mg and 10 mg also contain FD&C Blue #1 Aluminum Lake. The 12.5 mg, 15 mg, 20 mg and 30 mg also contain FD&C Yellow #6 Aluminum Lake.

Dextroamphetamine sulfate, USP is the dextro isomer of the compound d,l -amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d -alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate, USP as the neutral sulfate. The structural formula is as follows: (C 9 H 13 N) 2 ∙H 2 SO 4 M.W. 368.49 structural formula Inactive Ingredients Calcium sulfate, colloidal silicon dioxide, compressible sugar, corn starch, magnesium stearate, and microcrystalline cellulose. The 5 mg also contains D&C yellow no. 10 aluminum lake and FD&C red no. 40 aluminum lake. The 10 mg also contains FD&C red no. 40 aluminum lake and FD&C yellow no. 6 aluminum lake.

Diazepam tablets, USP are a benzodiazepine derivative. The chemical name of diazepam, USP is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is an off-white to yellow crystalline powder, insoluble in water. The structural formula is as follows: C 16 H 13 ClN 2 O M.W. 284.74 Diazepam tablets, USP are available as 2 mg, 5 mg, or 10 mg tablets for oral administration containing the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide; colorants: 5 mg only (D&C Yellow No. 10 aluminum lake and FD&C Yellow No. 6); 10 mg only (FD&C Blue No. 1 aluminum lake); magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate. Diazepam Structural Formula

DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is a nonsteroidal anti-inflammatory drug, available for topical application. DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is a 10 cm × 14 cm topical system comprised of an adhesive material containing 1.3% diclofenac epolamine which is applied to a non-woven polyester felt backing and covered with a polypropylene film release liner. The release liner is removed prior to topical application to the skin. The chemical name of diclofenac epolamine is 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, (2-(pyrrolidin-1-yl) ethanol salt, with a molecular formula of C 20 H 24 Cl 2 N 2 O 3, and molecular weight 411.3, an n-octanol/water partition coefficient of 8 at pH 8.5, and the following chemical structure: Each adhesive topical system contains 180 mg of diclofenac epolamine (13 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: butylene glycol, carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, fragrance (Dalin PH), gelatin, kaolin, methylparaben, polysorbate 80, povidone, propylene glycol, propylparaben, sodium polyacrylate, sorbitol solution, tartaric acid, titanium dioxide, and purified water. Chemical Structure

Diclofenac potassium tablets, USP are a benzeneacetic acid derivative. Diclofenac potassium tablets USP, 50 mg are available as orange, film-coated tablets for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monopotassium salt. The structural formula is: C 14 H 10 Cl 2 KNO 2 M.W. 334.24 g/mol Diclofenac potassium, USP is a faintly yellowish white to light beige, virtually odorless, slightly hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol and water, and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. It has a single dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each tablet, for oral administration, contains 50 mg of diclofenac potassium. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 4000, povidone, sodium starch glycolate, titanium dioxide, and tricalcium phosphate. 1

Dicloxacillin sodium, USP is an antibacterial agent of the isoxazolyl penicillin series. It is a penicillinase resistant, acid resistant semisynthetic penicillin suitable for oral administration. It is monosodium (2 S ,5 R ,6 R )-6-[3-(2,6-dichlorophenyl)-5-methyl-4-isoxazolecarboxamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0]heptane-2-carboxylate monohydrate, and has following structural formula: C 19 H 16 Cl 2 N 3 NaO 5 S·H 2 O MW 510.32 Each capsule for oral administration contains dicloxacillin sodium, USP equivalent to 250 mg or 500 mg of dicloxacillin. The inactive ingredient is Magnesium Stearate. The capsule shells and print constituents contains D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #1, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, D&C Yellow #10, Gelatin, Shellac, Sodium Lauryl Sulfate, Sorbitan Monolaurate, Black Iron Oxide, Titanium Dioxide, Propylene Glycol. Structural formula for dicloxacillin sodium

Diflunisal, USP is 2',4'-difluoro-4-hydroxy-3-biphenylcarboxylic acid. Its structural formula is: C 13 H 8 F 2 O 3 M.W. 250.20 Diflunisal, USP is a stable, white, crystalline compound with a melting point of 211° to 213°C. It is practically insoluble in water at neutral or acidic pH. Because it is an organic acid, it dissolves readily in dilute alkali to give a moderately stable solution at room temperature. It is soluble in most organic solvents including ethanol, methanol, and acetone. Each tablet, for oral administration, contains 500 mg diflunisal, USP. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, FD&C Blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol 3350, polyvinyl alcohol-part hydrolyzed, pregelatinized starch, sodium stearyl fumarate, talc, and titanium dioxide. Chemical structure for diflunisal

Diltiazem hydrochloride tablets, USP are a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride, USP is 1,5-Benzothiazepin-4(5 H )-one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)- cis -. The structural formula is: C 22 H 26 N 2 O 4 S•HCl M.W. 450.98 Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. Each tablet for oral administration contains 30 mg, 60 mg, 90 mg, or 120 mg of diltiazem hydrochloride, USP. Each tablet also contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, titanium dioxide and FD&C yellow No. 6 aluminum lake. structural formula

Disopyramide phosphate, USP is an antiarrhythmic drug available for oral administration in capsules containing 100 mg or 150 mg of disopyramide base, present as the phosphate. The base content of the phosphate salt is 77.6%. The structural formula of disopyramide phosphate, USP is: C 21 H 29 N 3 O•H 3 PO 4 M.W. 437.47 α-[2-(diisopropylamino) ethyl]-α-phenyl-2-pyridineacetamide phosphate Disopyramide phosphate, USP is freely soluble in water, and the free base (pKa 10.4) has an aqueous solubility of 1 mg/mL. The chloroform:water partition coefficient of the base is 3.1 at pH 7.2. Disopyramide phosphate, USP is a racemic mixture of d - and l -isomers. This drug is not chemically related to other antiarrhythmic drugs. Inactive Ingredients: lactose monohydrate, magnesium stearate and sodium starch glycolate. Capsule shell and ink ingredients: black iron oxide, D&C Red #28, D&C Red #33, D&C Yellow #10, FD&C Blue #1, gelatin, propylene glycol, shellac, sodium lauryl sulfate and titanium dioxide. 1

Doxazosin mesylate, USP is a quinazoline compound that is a selective inhibitor of the alpha 1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate, USP is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. It has the following structure: C 23 H 25 N 5 O 5 •CH 4 O 3 S M.W. 547.58 Doxazosin mesylate, USP is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. Each Doxazosin Tablet USP, for oral administration, contains doxazosin mesylate equivalent to 1 mg, 2 mg, 4 mg, or 8 mg of doxazosin as the free base. The inactive ingredients for all tablets are: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, sodium lauryl sulfate, and sodium starch glycolate. structure

Doxepin hydrochloride cream, 5% is a topical cream. Each gram contains: 50 mg of doxepin hydrochloride, USP (equivalent to 44.3 mg of doxepin). Doxepin hydrochloride, USP is one of a class of agents known as dibenzoxepin tricyclic antidepressant compounds. It is an isomeric mixture of N,N-dimethyldibenz[ b,e ]oxepin-∆ 11(6H),γ -propylaminehydrochloride. Doxepin hydrochloride, USP has a molecular formula of C 19 H 21 NO•HCl and a molecular weight of 315.84. Doxepin hydrochloride cream, 5% is a white cream and contains the following inactive ingredients: sorbitol solution, cetyl alcohol, isopropyl myristate, glyceryl stearate, PEG-100 stearate, white petrolatum, benzyl alcohol, titanium dioxide, and purified water. 1

Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing EFV USP, FTC, and TDF. EFV, USP is a non-nucleoside reverse transcriptase inhibitor (NNRTI). FTC is a synthetic nucleoside analog of cytidine. TDF, which is converted in vivo to tenofovir, is an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration. Each tablet contains 600 mg of EFV USP, 200 mg of FTC, and 300 mg of TDF (equivalent to 245 mg of tenofovir disoproxil) as active ingredients. The tablets include the following inactive ingredients: carmine, colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, poloxamer, polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, povidone, sodium starch glycolate, talc, and titanium dioxide. Efavirenz, USP: EFV, USP is chemically described as (4 S )-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2 H -3,1-benzoxazin-2-one. Its structural formula is: C 14 H 9 ClF 3 NO 2 M.W. 315.68 Efavirenz, USP is a white to slightly pink crystalline powder. It is freely soluble in methanol and practically insoluble in water (less than 10 mcg/mL). Emtricitabine: The chemical name of FTC is 5-fluoro-1- [ (2 R ,5 S )-2-(hydroxymethyl)-1,3-oxathiolan-5-yl ] cytosine. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has the following structural formula: C 8 H 10 FN 3 O 3 S M.W. 247.24 Emtricitabine is a white to off-white colored crystalline powder. It is freely soluble in water and in methanol. Tenofovir DF: TDF is a fumaric acid salt of the bis -isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of TDF is 9- [ ( R )-2 [[ bis [[ (isopropoxycarbonyl)oxy ] -methoxy ] phosphinyl ] methoxy ] propyl ] adenine fumarate. It has the following structural formula: C 19 H 30 N 5 O 10 P•C 4 H 4 O 4 M.W. 635.52 TDF is a white to off-white crystalline powder. It is practically insoluble in water. efavirenz structural formula emtricitabine structural formula tenofovir disoproxil fumarate structural formula

Eletriptan hydrobromide tablets contain eletriptan hydrobromide, which is a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D ) receptor agonist. Eletriptan hydrobromide is chemically designated as (R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole monohydrobromide, and it has the following chemical structure: C 22 H 26 N 2 O 2 S•HBr M.W. 463.43 Eletriptan hydrobromide is a white to light pale colored powder that is readily soluble in water. Each Eletriptan Hydrobromide Tablet for oral administration contains 24.2 or 48.5 mg of eletriptan hydrobromide equivalent to 20 mg or 40 mg of eletriptan, respectively. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, FD&C Yellow No. 6 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose FCC, polyethylene glycol, titanium dioxide, and triacetin. 1

Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine, USP (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine, USP: The chemical name of FTC is 5-fluoro-1-(2 R ,5 S )-[2-(hydroxymethyl)-1,3-oxathiolan-5­yl]cytosine. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has the following structural formula: C 8 H 10 FN 3 O 3 S M.W. 247.25 FTC is a white to off-white crystalline powder with a solubility of approximately 112 mg/mL in water at 25°C. The partition coefficient (log p) for emtricitabine is −0.43 and the pKa is 2.65. Tenofovir Disoproxil Fumarate: TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[( R )-2[[bis[[(isopropoxycarbonyl)oxy]- methoxy]phosphinyl]methoxy]propyl]adenine fumarate. It has the following structural formula: C 19 H 30 N 5 O 10 P • C 4 H 4 O 4 M.W. 635.52 Tenofovir disoproxil fumarate is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in water at 25°C. The partition coefficient (log p) for tenofovir disoproxil is 1.25 and the pKa is 3.75. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration. Each film-coated tablet contains 200 mg of emtricitabine, USP and 300 mg of tenofovir DF (which is equivalent to 245 mg of tenofovir disoproxil), as active ingredients. The tablets also include the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, mannitol, polyethylene glycol, polyvinyl alcohol, povidone, talc, and titanium dioxide. Emtricitabine Structure Tenofovir Disoproxil Fumarate

Epinephrine Injection USP, 0.3 mg and Epinephrine Injection USP, 0.15 mg are single-dose auto-injectors and combination products containing drug and device components. Each Epinephrine Injection USP, 0.3 mg (Auto-Injector) delivers a single dose of 0.3 mg epinephrine, USP from epinephrine injection USP, 0.3 mg/0.3 mL in a sterile solution. Each Epinephrine Injection USP, 0.15 mg (Auto-Injector) delivers a single dose of 0.15 mg epinephrine, USP from epinephrine injection USP, 0.15 mg/0.3 mL in a sterile solution. Each 0.3 mL in the Epinephrine Injection USP, 0.3 mg (Auto-Injector) contains 0.3 mg epinephrine USP, 1.8 mg sodium chloride, 0.4 mg sodium metabisulfite, 0.4 mg sodium tartrate (dihydrate), hydrochloric acid to adjust pH, and water for injection. The pH range is 2.2 to 5.0. Each 0.3 mL in the Epinephrine Injection USP, 0.15 mg (Auto-Injector) contains 0.15 mg epinephrine USP, 1.8 mg sodium chloride, 0.4 mg sodium metabisulfite, 0.2 mg sodium tartrate (dihydrate), hydrochloric acid to adjust pH, and water for injection. The pH range is 2.2 to 5.0. Epinephrine, USP is a sympathomimetic catecholamine. Chemically, epinephrine, USP is (-)-3,4-Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure: Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace Epinephrine Injection USP, 0.3 mg and Epinephrine Injection USP, 0.15 mg if the epinephrine solution appears discolored (pinkish or darker than slightly yellow), cloudy, or if it contains a precipitate. Thoroughly review the patient instructions and operation of Epinephrine Injection USP, 0.3 mg or Epinephrine Injection USP, 0.15 mg with patients and caregivers prior to use [ see Patient Counseling Information ( 17 ) ]. structure

Epitol (carbamazepine tablets, USP), is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as tablets of 200 mg. Its chemical name is 5 H -dibenz[ b,f ]azepine-5-carboxamide, and its structural formula is: C 15 H 12 N 2 O M.W. 236.27 Carbamazepine, USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Epitol (carbamazepine tablets, USP) 200 mg contain the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, ethylcellulose, glycerin, lactose monohydrate, magnesium stearate, and sodium starch glycolate. Epitol 200 mg tablets meet USP Dissolution Test 3. Chemical Image.jpg

Eculizumab-aagh, a complement inhibitor, is a recombinant humanized monoclonal IgG2/4 κ antibody produced in a Chinese Hamster Ovary cell line expression system and purified by standard bioprocess technology . Eculizumab-aagh contains human constant regions from human IgG2 sequences and human IgG4 sequences and murine complementarity-determining regions grafted onto the human framework light- and heavy-chain variable regions. Eculizumab-aagh is composed of two 448 amino acid heavy chains and two 214 amino acid light chains and has a molecular weight of approximately 148 kDa. EPYSQLI (eculizumab-aagh) injection is a sterile, preservative-free, clear to slightly opalescent and colorless solution for intravenous infusion and is supplied in a 30 mL single-dose vial. Each mL contains 10 mg of eculizumab-aagh, dibasic sodium phosphate (0.77 mg), monobasic sodium phosphate (0.55 mg), polysorbate 80 (0.22 mg) (vegetable origin), trehalose (86 mg), and Water for Injection, USP. The pH is 7.

Erlotinib Tablets, a kinase inhibitor, is a quinazolinamine with the chemical name N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine. Erlotinib Tablets contain erlotinib as the hydrochloride salt that has the following structural formula: C 22 H 23 N 3 O 4 •HCl M.W. 429.90 The molecule has a pK a of 5.42 at 25°C. Erlotinib hydrochloride is very slightly soluble in water, slightly soluble in methanol and practically insoluble in acetonitrile, acetone, ethyl acetate and hexane. Aqueous solubility of erlotinib hydrochloride is dependent on pH with increased solubility at a pH of less than 5 due to protonation of the secondary amine. Over the pH range of 1.4 to 9.6, maximal solubility of approximately 0.4 mg/mL occurs at a pH of approximately 2. Erlotinib Tablets for oral administration are available in three dosage strengths containing erlotinib hydrochloride (27.3 mg, 109.3 mg and 163.9 mg) equivalent to 25 mg, 100 mg and 150 mg erlotinib and the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide, and triacetin. erlotinib hydrochloride structural formula

Erythromycin tablets, USP are an antibacterial product containing erythromycin USP, in a unique, nonenteric film coating for oral administration. Erythromycin tablets, USP are available in two strengths containing either 250 mg or 500 mg of erythromycin, USP base. Erythromycin, USP is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus ) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin, USP is a white or slightly yellow crystal, slightly soluble in water, and soluble in alcohol, chloroform, and ether. Erythromycin, USP is known chemically as (3 R *, 4 S *, 5 S *, 6 R *, 7 R *, 9 R *, 11 R *, 12 R *, 13 S *, 14 R *)-4-[(2,6-Dideoxy-3- C -methyl-3- O -methyl-α-L- ribo -hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D- xylo -hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C 37 H 67 NO 13 , and the molecular weight is 733.94. The structural formula is: FDA approved dissolution test specifications differ from USP 1 Inactive Ingredients Colloidal silicon dioxide, croscarmellose sodium, crospovidone type B, FD&C Red No. 40, hydroxypropyl cellulose, hypromellose 2910, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, povidone K30, propylene glycol, sorbic acid, talc, titanium dioxide, and tri-sodium citrate dihydrate.

Estradiol Tablets, USP for oral administration contains 0.5, 1 or 2 mg of micronized estradiol, USP per tablet. Estradiol, USP (17β-estradiol) is a white, crystalline solid, chemically described as estra-1,3,5,(10)-triene-3, 17β-diol. The structural formula is: C 18 H 24 O 2 M.W. 272.38 Inactive Ingredients: Colloidal silicon dioxide, corn starch, dibasic calcium phosphate, lactose monohydrate, magnesium stearate, and sodium starch glycolate. In addition, the 1 mg also contains FD&C blue no. 1 aluminum lake and D&C red no. 27 aluminum lake. The 2 mg also contains FD&C blue no. 1 aluminum lake and FD&C yellow no. 5 (tartrazine) aluminum lake. structual formula

Each gram of estradiol vaginal cream, USP, 0.01% contains 0.1 mg estradiol in a nonliquefying base containing purified water, propylene glycol, stearyl alcohol, white ceresin wax, mono- and di-glycerides, hypromellose 2208 (4000 cps), sodium lauryl sulfate, methylparaben, edetate di-sodium and tertiary -butylhydroquinone. Estradiol is chemically described as estra-1,3,5(10)-triene-3, 17(beta)-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.37. The structural formula is: structural formula

Estradiol vaginal inserts USP, 10 mcg are white to off-white, round, film-coated, unscored, biconvex inserts containing 10.3 mcg of estradiol hemihydrate, USP equivalent to 10 mcg of estradiol. Each 10 mcg estradiol vaginal insert contains the following excipients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, and polyethylene glycol. Each estradiol vaginal insert 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 are used intravaginally. When the insert comes in contact with the vaginal mucosa, estradiol is released into the vagina. Estradiol hemihydrate, USP is white to practically white crystals or powder and chemically described as estra1,3,5 (10)-triene-3,17β-diol, hydrate (2:1). The structural formula is: C 18 H 24 O 2 . 1/2 H 2 O M.W. 281.4 (Estradiol hemihydrate, USP) FDA approved dissolution test specifications differ from USP. Chemical structure

Eszopiclone, USP is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone, USP is (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1-carboxylate. Eszopiclone, USP has a single chiral center with an ( S )-configuration. It has the following chemical structure: C 17 H 17 ClN 6 O 3 M.W. 388.81 Eszopiclone, USP is a white to slightly yellowish crystalline powder. Eszopiclone, USP is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2). Eszopiclone, USP is formulated as film-coated tablets for oral administration. Eszopiclone Tablets, USP contain 1 mg, 2 mg, or 3 mg of eszopiclone, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, anhydrous hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Additionally, the 1 mg tablet contains FD&C blue #1/aluminum lake; the 2 mg tablet contains polysorbate 80; and the 3 mg tablet contains FD&C blue #2/aluminum lake. Molecular structure