ani pharmaceuticals, inc. - Medication Listings

Hydrochlorothiazide, USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula: Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. The molecular formula is C 7 H 8 ClN 3 O 4 S 2 and the molecular weight is 297.74. INZIRQO (hydrochlorothiazide) is supplied in one strength as an off-white to light-brown colored powder for oral suspension. When reconstituted with 66 mL of water, the total volume of the suspension is 80 mL containing 10 mg/mL of hydrochlorothiazide, USP. In addition, INZIRQO contains the following inactive ingredients: anhydrous citric acid, caramel flavor (artificial flavor, caramel, maltodextrin, molasses, propylene glycol, salt and sucrose), cellulose, peppermint flavor (acacia and natural flavor), potassium sorbate, sucrose, talc and xanthan gum. structure

Sertraline HCl Capsules contain sertraline HCl, a selective serotonin reuptake inhibitor (SSRI). Sertraline HCl has a molecular weight of 342.7 and has the following chemical name: (1S,4S)-4-(3,4-dichlorophenyl)­N-methyl-tetralin-1-amine hydrochloride. The empirical formula C 17 H 17 Cl 2 N • HCl is represented by the following structural formula: Sertraline HCl is a white to almost white crystalline powder that is slightly soluble in water, acetone and isopropyl alcohol. Sertraline HCl Capsules are for oral administration and contain 168 mg and 224 mg sertraline HCl, equivalent to 150 mg and 200 mg sertraline, and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, and microcrystalline cellulose. The capsule shells contain titanium dioxide, gelatin, purified water. Additionally, the 150 mg capsules contain D&C Yellow No. 10 and FD&C Red No. 40 as color additives, the 200 mg capsules contain D&C Yellow No. 10 and FD&C Blue No. 1 as color additives. The imprinting ink contains shellac, black iron oxide, potassium hydroxide, and propylene glycol. Structure

Prednisone Tablets, USP contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione, 17,21-dihydroxy-. The structural formula is represented below: Molecular Formula: C 21 H 26 O 5 Molecular Weight: 358.44 Prednisone is a white or almost white crystalline powder. It is slightly soluble in acetone, ethanol, ethylacetate and methanol. Prednisone Tablets, USP 1 mg are available for oral administration containing 1 mg of prednisone, USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and sodium starch glycolate. Meets USP Dissolution Test 2. structure

Prednisone Tablets, USP are available for oral administration containing 2.5 mg, 5 mg, 10 mg, 20 mg and 50 mg of prednisone, USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and sodium starch glycolate. Prednisone Tablets, USP contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione, 17,21-dihydroxy-. The structural formula is represented below: Molecular Formula: C21H26O5 Molecular Weight: 358.44 Prednisone is a white or almost white crystalline powder. It is slightly soluble in acetone, ethanol, ethylacetate and methanol. Meets USP Dissolution Test 2. structure

Fluoxetine oral solution, USP is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy] propylamine hydrochloride and has the empirical formula of C 17 H 18 F 3 NO∙HCl. Its molecular weight is 345.79. The structural formula is: Fluoxetine Hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. The oral solution contains Fluoxetine Hydrochloride, USP equivalent to 20 mg per 5 mL (64.7 μmol) of fluoxetine. It also contains the following inactive ingredients: glycerin, purified water, sodium benzoate, artificial cherry flavor, and sucrose, and contains hydrochloric acid to adjust the pH. structure

Meloxicam capsules are a nonsteroidal anti-inflammatory drug, available as white capsules containing 5 mg or 10 mg for oral administration. The chemical name is 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1­dioxide. The molecular weight is 351.40. Its molecular formula is C 14 H 13 N 3 O 4 S 2 , and it has the following chemical structure. Meloxicam is a pale yellow powder, practically insoluble in water, slightly soluble in acetone; soluble in dimethylformamide; very slightly soluble in ethanol 96% and in methanol. Meloxicam has an apparent partition coefficient (log P) =0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. The inactive ingredients in meloxicam include: croscarmellose sodium, lactose monohydrate, magnesium stearate, meglumine, microcrystalline cellulose, povidone and sodium lauryl sulfate. The capsule shells contain: gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell is imprinted in black edible ink which contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. structure

Each scored oxybutynin chloride tablet, USP contains 5 mg of oxybutynin chloride. Chemically, oxybutynin chloride is d, l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The molecular formula of oxybutynin chloride is C 22 H 31 NO 3 •HCl. The structural formula appears below: Oxybutynin chloride, USP is a white crystalline solid with a molecular weight of 393.95. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin chloride Tablets, USP also contains anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose. Oxybutynin chloride tablets, USP are for oral administration. Therapeutic Category: Antispasmodic, anticholinergic. Meets USP Dissolution Test 2. STRUCTURE

Paroxetine Oral Suspension contains paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans -4 R -(4'-fluorophenyl)-3 S -[(3',4'­methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C 19 H 20 FNO 3 •HCl•1/2H 2 O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is: Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120° to 138°C and a solubility of 5.4 mg/mL in water. Paroxetine Oral Suspension Paroxetine Oral Suspension is for oral administration. Each 5 mL contains 10 mg of paroxetine equivalent to 11.1 mg of paroxetine hydrochloride. Inactive ingredients consist of polacrilin potassium, microcrystalline cellulose, carboxymethyl cellulose sodium, propylene glycol, glycerin, sorbitol, methylparaben, propylparaben, sodium citrate dihydrate, citric acid anhydrous, sodium saccharin, orange flavor (triacetin, propylene glycol, natural and artificial flavor), FD&C Yellow No. 6, simethicone emulsion and purified water. structure

Naproxen Delayed-Release Tablets, USP are nonsteroidal anti-inflammatory drugs available as enteric-coated tablets containing 375 mg of naproxen or 500 mg of naproxen for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 with the following structure: Naproxen is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The inactive ingredients in Naproxen Delayed-Release Tablets, USP include: croscarmellose sodium, povidone, colloidal silicon dioxide and magnesium stearate. The enteric coating dispersion contains methacrylic acid and ethyl acrylate copolymer, triethyl citrate, talc and purified water. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4. structure

Acebutolol hydrochloride USP is a selective, hydrophilic beta-adrenoreceptor blocking agent with mild intrinsic sympathomimetic activity for use in treating patients with hypertension and ventricular arrhythmias. It is marketed in capsule form for oral administration. Acebutolol Hydrochloride Capsules USP are provided in two dosage strengths which contain 200 mg or 400 mg of acebutolol as the hydrochloride salt. The inactive ingredients are povidone, corn starch, pregelatinized starch, and stearic acid. The capsule shells and imprinting ink for the 200 mg dosage strength also contain FD&C Blue 1, FD&C Red 40, titanium dioxide, black iron oxide, yellow iron oxide, sodium lauryl sulfate, gelatin, carboxymethylcellulose, shellac, ammonium hydroxide, propylene glycol, and potassium hydroxide. The capsule shells and imprinting ink for the 400 mg dosage strength also contain FD&C Blue 1, FD&C Red 3, titanium dioxide, FD&C Yellow 6, D&C Yellow 10, sodium lauryl sulfate, gelatin, shellac, ammonium hydroxide, propylene glycol, simethicone, and sodium hydroxide. Acebutolol hydrochloride USP has the following structural formula: C 18 H 28 N 2 O 4 •HCl M.W. 372.9 Acebutolol hydrochloride USP is a white or slightly off-white powder freely soluble in water, and less soluble in alcohol. Chemically it is defined as the hydrochloride salt of (±)N-[3-Acetyl-4-[2-hydroxy-3-[(1-methylethyl)amino]propoxy]phenyl] butanamide. Structure

Acetazolamide, USP an inhibitor of the enzyme carbonic anhydrase, is a white to faintly yellowish white crystalline, odorless powder, weakly acidic, very slightly soluble in water and slightly soluble in alcohol. The chemical name for acetazolamide is N-(5-Sulfamoyl-1,3,4-thiadiazol-2-yl)-acetamide and has the following chemical structure: Acetazolamide Tablets, USP are available for oral administration each containing 125 mg and 250 mg of acetazolamide, USP respectively. Additionally, they contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone K30, talc. Meets USP Dissolution Test 2. structure

Acyclovir, a synthetic nucleoside analogue active against herpesviruses. Acyclovir Oral Suspension, USP 200 mg/5 mL is formulation for oral administration. Each teaspoonful (5 mL) of Acyclovir Oral Suspension, USP contains 200 mg of acyclovir and the inactive ingredients methylparaben 0.1% and propylparaben 0.02% (added as preservatives), carboxymethylcellulose sodium, banana flavor, glycerin, microcrystalline cellulose, purified water and sorbitol. Acyclovir is a white, crystalline powder with the molecular formula C 8 H 11 N 5 O 3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir are 2.27 and 9.25.The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one;it has the following structural formula: VIROLOGY Mechanism of Antiviral Action : Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared to VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities : The quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC 50 ), vary greatly depending upon a number of factors. Using plaque-reduction assays, the IC 50 against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC 50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC50 of 1.35 mcg/mL. Drug Resistance : Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy. structure

Alendronate Sodium Oral Solution is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The empirical formula of alendronate sodium is C 4 H 12 NNaO 7 P 2 ·3H 2 O and its formula weight is 325.12. The structural formula is: Alendronate sodium USP is a white powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Each bottle of the oral solution contains 91.35 mg of alendronate monosodium salt trihydrate, which is the molar equivalent to 70 mg of free acid. Each bottle also contains the following inactive ingredients: citric acid (anhydrous), methylparaben, propylparaben, purified water, raspberry flavor, saccharin sodium and sodium citrate dihydrate. structure

Alprazolam Tablets, USP contains alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is: Alprazolam is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each Alprazolam Tablet, USP for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam, USP. Inactive ingredients: anhydrous lactose, crospovidone, pregelatinized starch, docusate sodium, sodium benzoate, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate. In addition, the 0.5 mg tablet contains D&C Yellow No. 10 and the 1 mg and 2 mg tablets contain D&C Yellow No. 10 Aluminum lake and FD&C Blue No. 2. structure

Anagrelide hydrochloride, USP is a platelet-reducing agent. Its chemical name is 6,7-dichloro-1,5-dihydroimidazo[2,1-b]quinazolin-2(3H)-one monohydrochloride monohydrate. The molecular formula is C 10 H 7 Cl 2 N 3 O•HCl•H 2 O which corresponds to a molecular weight of 310.59. The structural formula is: Anagrelide hydrochloride is an off-white powder. It is very slightly soluble in water and sparingly soluble in dimethyl sulfoxide and dimethylformamide. Each Anagrelide Capsule USP, for oral administration, contains either 0.5 mg or 1 mg of anagrelide base (as anagrelide hydrochloride, USP) and has the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, crospovidone, povidone, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsules contain titanium dioxide, gelatin, FD&C Red No. 40 and purified water. The 0.5 mg capsules also contain black iron oxide, and FD&C Red No. 3. The 1 mg capsules also contain FD&C Blue No. 1, and FD&C Yellow No. 6. In addition, the black imprinting ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and ammonia. structure

ARIMIDEX (anastrozole) tablets for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a', a'-tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl). Its molecular formula is C 17 H 19 N 5 and its structural formula is: Anastrozole is an off-white powder with a molecular weight of 293.4. Anastrozole has moderate aqueous solubility (0.5 mg/mL at 25°C); solubility is independent of pH in the physiological range. Anastrozole is freely soluble in methanol, acetone, ethanol, and tetrahydrofuran, and very soluble in acetonitrile. Each tablet contains as inactive ingredients: lactose, magnesium stearate, hypromellose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide. Chemical Structure for anastrozole

ATACAND (candesartan cilexetil), a prodrug, is hydrolyzed to candesartan during absorption from the gastrointestinal tract. Candesartan is a selective AT 1 subtype angiotensin II receptor antagonist. Candesartan cilexetil, a nonpeptide, is chemically described as (±)-1-Hydroxyethyl 2-ethoxy-1-[ p-(o -1 H -tetrazol-5-ylphenyl)benzyl]-7-benzimidazolecarboxylate, cyclohexyl carbonate (ester). Its empirical formula is C 33 H 34 N 6 O 6 , and its structural formula is: Candesartan cilexetil is a white to off-white powder with a molecular weight of 610.67. It is practically insoluble in water and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral. ATACAND is available for oral use as tablets containing either 4 mg, 8 mg, 16 mg, or 32 mg of candesartan cilexetil and the following inactive ingredients: hydroxypropyl cellulose, polyethylene glycol, lactose, corn starch, carboxymethylcellulose calcium, and magnesium stearate. Ferric oxide (reddish brown) is added to the 8-mg, 16-mg, and 32-mg tablets as a colorant. structural formula

ATACAND HCT (candesartan cilexetil-hydrochlorothiazide) combines an angiotensin II receptor (type AT 1 ) antagonist and a diuretic, hydrochlorothiazide. Candesartan cilexetil, a nonpeptide, is chemically described as (±)-1-Hydroxyethyl 2-ethoxy-1-[ p -( o -1 H -tetrazol-5-ylphenyl)benzyl]-7-benzimidazolecarboxylate, cyclohexyl carbonate (ester). Its empirical formula is C 33 H 34 N 6 O 6 and its structural formula is: Candesartan cilexetil is a white to off-white powder with a molecular weight of 610.67. It is practically insoluble in water and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7 H 8 ClN 3 O 4 S 2 and its structural formula is: Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.72, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. ATACAND HCT is available for oral administration in three tablet strengths of candesartan cilexetil and hydrochlorothiazide. ATACAND HCT 16-12.5 contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide. ATACAND HCT 32-12.5 contains 32 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide. ATACAND HCT 32-25 contains 32 mg of candesartan cilexetil and 25 mg of hydrochlorothiazide. The inactive ingredients of the tablets are carboxymethylcellulose calcium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, cornstarch, polyethylene glycol 8000, and ferric oxide (yellow). Ferric oxide (reddish brown) is also added to the 16-12.5 mg and 32-25 mg tablets as colorant. Chemical Structure for Candesartan cilexetil Chemical Structure for Hydrochlorothiazide

Atenolol and Chlorthalidone Tablets, USP are for the treatment of hypertension. It combines the antihypertensive activity of two agents: a beta 1 -selective (cardioselective) hydrophilic blocking agent (atenolol) and a monosulfonamyl diuretic (chlorthalidone). Atenolol is Benzeneacetamide, 4-[2'-hydroxy-3'-[(1-methylethyl) amino] propoxy]-. Atenolol (free base) is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Chlorthalidone is 2-Chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl) benzene sulfonamide: Chlorthalidone has a water solubility of 12 mg/100 mL at 20°C. Each Atenolol and Chlorthalidone Tablet, USP 100 mg/25 mg contains: Atenolol, USP ....................................... 100 mg Chlorthalidone, USP ........................................................ 25 mg Each Atenolol and Chlorthalidone Tablet, USP 50 mg/25 mg contains: Atenolol, USP ......................................... 50 mg Chlorthalidone, USP ….................................................... 25 mg Inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate. Structure 2

Baclofen oral suspension is a gamma-aminobutyric acid (GABA-ergic) agonist available as 25 mg per 5 mL (5 mg/mL) suspension for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is: Molecular formula is C 10 H 12 C1NO 2 . Molecular Weight is 213.66 g/mol. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. The baclofen oral suspension inactive ingredients are artificial grape flavor, hydrochloric acid, hypromellose, methyl paraben, propyl paraben, purified water, simethicone emulsion, sodium hydroxide, sucralose, and xanthan gum. Structure

Benazepril hydrochloride USP is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride’s chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1 H -1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is Its empirical formula is C 24 H 28 N 2 O 5 ·HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Hydrochlorothiazide USP is a white or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide’s chemical name is 6-chloro-3,4-dihydro-2 H -1,2,4- benzothiadiazine-7-sulfonamide 1,1-dioxide; its structural formula is Its empirical formula is C 7 H 8 ClN 3 O 4 S 2 , and its molecular weight is 297.73. Hydrochlorothiazide is a thiazide diuretic. Benazepril Hydrochloride and Hydrochlorothiazide Tablets USP are a combination of benazepril hydrochloride USP and hydrochlorothiazide USP. The tablets are formulated for oral administration with a combination of 5, 10 or 20 mg of benazepril hydrochloride USP and 6.25, 12.5 or 25 mg of hydrochlorothiazide USP. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide and triacetin. The 10 mg/12.5 mg tablets also contain FD&C Blue #2 and iron oxide red. The 20 mg/12.5 mg tablets also contain FD&C Red #40 and FD&C Yellow #6. The 20 mg/25 mg tablets also contain FD&C Blue #2 and FD&C Red #40. Benazepril Hydrochloride and Hydrochlorothiazide Tablets USP meet USP Dissolution Test 2. Benazepril-structure.jpg Hydrochlorothiazide-structure.jpg

Bexarotene capsules contain bexarotene, a member of a subclass of retinoids that selectively activate retinoid X receptors (RXRs). These retinoid receptors have biologic activity distinct from that of retinoic acid receptors (RARs). The chemical name of bexarotene is 4-[1-(5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl) ethenyl] benzoic acid, and the structural formula is as follows: Bexarotene is an off-white to white powder with a molecular weight of 348.48 and a molecular formula of C 24 H 28 O 2 . It is insoluble in water and slightly soluble in vegetable oils and ethanol, USP. Each bexarotene capsule contains 75 mg of bexarotene for oral administration. It also contains the following inactive ingredients: gelatin, nitrogen, butylated hydroxyanisole, glycerin, hydrolyzed gelatin, medium chain triglyceride, Shellac glaze, FD&C red #40, FD&C blue #1, FD&C yellow #6, propylene glycol, simethicone, polyethylene glycol 400, polysorbate 20, povidone, sorbitol, 1,4-sorbitan, mannitol, soy lecithin and titanium dioxide. structure

Bicalutamide Tablets USP contain 50 mg of bicalutamide USP, a non-steroidal androgen receptor inhibitor with no other known endocrine activity. The chemical name is propanamide, N [4 cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methyl-,(+-). The structural and empirical formulas are: Bicalutamide has a molecular weight of 430.37. The pKa is approximately 12. Bicalutamide is a fine white to off-white powder which is practically insoluble in water at 37°C (5 mg per 1000 mL), slightly soluble in chloroform and absolute ethanol, sparingly soluble in methanol, and soluble in acetone and tetrahydrofuran. Bicalutamide is a racemate with its antiandrogenic activity being almost exclusively exhibited by the R-enantiomer of bicalutamide; the S-enantiomer is essentially inactive. The inactive ingredients of Bicalutamide Tablets USP are lactose, magnesium stearate, hypromellose, polyethylene glycol, polyvidone, sodium starch glycollate, and titanium dioxide. chem

Bisoprolol fumarate and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta 1 -selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate is chemically described as (±)-1-[4-[[2-(1-methylethoxy)ethoxy]methyl] phenoxy]-3-[(1-methylethyl)amino]-2-propanol( E )-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C 18 H 31 NO 4 ) 2 •C 4 H 4 O 4 and it has a molecular weight of 766.97. Its structural formula is: Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1- dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C 7 H 8 ClN 3 O 4 S 2 and it has a molecular weight of 297.73. Its structural formula is: Each bisoprolol fumarate and hydrochlorothiazide - 2.5 mg/6.25 mg tablet, USP for oral administration contains: Bisoprolol fumarate…………………………………………..2.5 mg Hydrochlorothiazide………………………………………..6.25 mg Each bisoprolol fumarate and hydrochlorothiazide - 5 mg/6.25 mg tablet, USP for oral administration contains: Bisoprolol fumarate…………………………………………… 5 mg Hydrochlorothiazide……………………………………….. 6.25 mg Each bisoprolol fumarate and hydrochlorothiazide - 10 mg/6.25 mg tablet, USP for oral administration contains: Bisoprolol fumarate…………………………………………...10 mg Hydrochlorothiazide……………………………………….. 6.25 mg Inactive ingredients include pregelatinized starch, anhydrous dicalcium phosphate, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide. The 10 mg/6.25mg tablet also contains FD&C blue #1 aluminum lake. The 5 mg/6.25 mg tablet also contains iron oxide red & ferrosoferric oxide. The 2.5 mg/6.25 mg tablet also contains ferric oxide. FDA approved dissolution test specifications differ from USP. Bisoprolol-Fumarate thiazide-structure

Bromocriptine mesylate is an ergot derivative with potent dopamine receptor agonist activity. Each bromocriptine mesylate tablet for oral administration contains 2.5 mg bromocriptine (as the mesylate). Bromocriptine mesylate is chemically designated as Ergotaman-3′, 6′, 18- trione, 2-bromo-12′- hydroxy-2′-(1-methylethyl)-5′-(2-methylpropyl)-,(5′α) -monomethanesulfonate (salt). The structural formula is: 2.5 mg Tablets Active Ingredient: bromocriptine mesylate, USP Inactive Ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, maleic acid, povidone, and corn starch. Meets USP Dissolution Test 1. structure

Candesartan cilexetil, a prodrug, is hydrolyzed to candesartan during absorption from the gastrointestinal tract. Candesartan is a selective AT 1 subtype angiotensin II receptor antagonist. Candesartan cilexetil, a nonpeptide, is chemically described as (±)-1-Hydroxyethyl 2-ethoxy-1-[ p-(o -1 H -tetrazol-5-ylphenyl)benzyl]-7-benzimidazolecarboxylate, cyclohexyl carbonate (ester). Its empirical formula is C 33 H 34 N 6 O 6 , and its structural formula is Candesartan cilexetil is a white to off-white powder with a molecular weight of 610.67. It is practically insoluble in water and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral. Candesartan cilexetil is available for oral use as tablets containing either 4 mg, 8 mg, 16 mg, or 32 mg of candesartan cilexetil and the following inactive ingredients: hydroxypropyl cellulose, polyethylene glycol, lactose, corn starch, carboxymethylcellulose calcium, and magnesium stearate. Ferric oxide (reddish brown) is added to the 8-mg, 16-mg, and 32-mg tablets as a colorant. structural formula

Candesartan Cilexetil and Hydrochlorothiazide Tablets USP combine an angiotensin II receptor (type AT 1 ) antagonist and a diuretic, hydrochlorothiazide. Candesartan cilexetil, a nonpeptide, is chemically described as (±)-1-Hydroxyethyl 2-ethoxy-1-[ p -( o -1 H -tetrazol-5-ylphenyl)benzyl]-7-benzimidazolecarboxylate, cyclohexyl carbonate (ester). Its empirical formula is C 33 H 34 N 6 O 6 and its structural formula is: Candesartan cilexetil is a white to off-white powder with a molecular weight of 610.67. It is practically insoluble in water and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7 H 8 ClN 3 O 4 S 2 and its structural formula is: Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.72, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Candesartan cilexetil and hydrochlorothiazide tablets are available for oral administration in three tablet strengths of candesartan cilexetil and hydrochlorothiazide. Candesartan cilexetil and hydrochlorothiazide tablets contain 16 mg or 32 mg of candesartan cilexetil and 12.5 mg or 25 mg of hydrochlorothiazide providing for the following available combinations: 16 mg/12.5 mg, 32 mg/12.5 mg or 32 mg/25 mg. The inactive ingredients of the tablets are carboxymethylcellulose calcium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, corn starch, polyethylene glycol 8000, and ferric oxide (yellow). Ferric oxide (reddish brown) is also added to the 16 mg/12.5 mg and 32 mg/25 mg tablets as colorant. Chemical Structure for Candesartan cilexetil Chemical Structure for Hydrochlorothiazide

Carbamazepine, USP is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as a suspension of 100 mg/5 mL (teaspoon). Its chemical name is 5 H -dibenz[ b,f ]azepine-5-carboxamide, and its structural formula is: Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in methanol. Its molecular weight is 236.27 g/mol. Inactive Ingredients : sucrose, propylene glycol, xanthan gum, potassium sorbate, poloxamer 188, sorbitol, anhydrous citric acid, FD&C Yellow No.6 powder, vanilla flavor and water.The amount of propylene glycol in carbamazepine oral suspension is 8 mg per mL (see WARNINGS Propylene Glycol Toxicity). structure

Carboprost Tromethamine Injection USP, an oxytocic, contains the tromethamine salt of the (15S)-15 methyl analogue of naturally occurring prostaglandin F2α in a solution suitable for intramuscular injection. Carboprost tromethamine is the established name for the active ingredient in Carboprost Tromethamine Injection USP. Four other chemical names are: 1. (15S)-15-methyl prostaglandin F2α tromethamine salt 2. 7-(3α,5α-dihydroxy-2ß-[(3S)-3-hydroxy-3-methyl- trans -1-octenyl]-1α-cyclopentyl]- cis -5-heptenoic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol 3. (15S)-9α,11α,15-trihydroxy-15-methylprosta- cis -5, trans -13-dienoic acid tromethamine salt 4. (15S)-15-methyl PGF2α-THAM The structural formula is represented below: The molecular formula is C 25 H 47 O 8 N. The molecular weight of carboprost tromethamine is 489.64. It is a white to slightly off-white crystalline powder. It generally melts between 95° and 105° C, depending on the rate of heating. Carboprost tromethamine dissolves readily in water at room temperature at a concentration greater than 75 mg/mL. Each mL of Carboprost Tromethamine Injection USP contains carboprost tromethamine equivalent to 250 mcg of carboprost, 83 mcg tromethamine, 9 mg sodium chloride, 9.45 mg benzyl alcohol added as preservative, and water for injection. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid. The solution is sterile. Structure

CASODEX ® (bicalutamide) tablets contain 50 mg of bicalutamide, a non-steroidal androgen receptor inhibitor with no other known endocrine activity. The chemical name is propanamide, N [4 cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methyl-,(+-). The structural and empirical formulas are: Bicalutamide has a molecular weight of 430.37. The pKa is approximately 12. Bicalutamide is a fine white to off-white powder which is practically insoluble in water at 37°C (5 mg per 1000 mL), slightly soluble in chloroform and absolute ethanol, sparingly soluble in methanol, and soluble in acetone and tetrahydrofuran. CASODEX is a racemate with its antiandrogenic activity being almost exclusively exhibited by the R-enantiomer of bicalutamide; the S-enantiomer is essentially inactive. The inactive ingredients of CASODEX tablets are lactose, magnesium stearate, hypromellose, polyethylene glycol, polyvidone, sodium starch glycollate, and titanium dioxide. chem

Clomiphene Citrate Tablets, USP is an orally administered, nonsteroidal, ovulatory stimulant designated chemically as 2-[p-(2-chloro-1,2-diphenylvinyl)phenoxy] triethylamine citrate (1:1). It has the molecular formula of C 26 H 28 ClNO • C 6 H 8 O 7 and a molecular weight of 598.09. It is represented structurally as: Clomiphene citrate is a white to pale yellow, essentially odorless, crystalline powder. It is freely soluble in methanol; soluble in ethanol; slightly soluble in acetone, water, and chloroform; and insoluble in ether. Clomiphene citrate is a mixture of two geometric isomers [cis (zuclomiphene) and trans (enclomiphene)] containing between 30% and 50% of the cis-isomer. Each off-white scored tablet contains 50 mg clomiphene citrate, USP. The tablet also contains the following inactive ingredients: corn starch, pregelatinized starch, lactose monohydrate, magnesium stearate, and sucrose. FDA approved dissolution test specifications differ from USP. structure

Chemically, clorazepate dipotassium is a benzodiazepine. The empirical formula is C 16 H 11 ClK 2 N 2 O 4 ; the molecular weight is 408.92; 1 H -1, 4 Benzodiazepine-3-carboxylic acid, 7-chloro-2, 3-dihydro-2-oxo-5-phenyl-, potassium salt compound with potassium hydroxide (1:1) and the structural formula may be represented as follows: The compound occurs as a fine, white or light yellow, practically odorless powder. It is insoluble in the common organic solvents, but very soluble in water. Aqueous solutions are unstable, clear, light yellow, and alkaline. Each Clorazepate Dipotassium Tablet, USP 3.75 mg contains clorazepate equivalent to 2.9 mg. Each Clorazepate Dipotassium Tablet, USP 7.5 mg contains clorazepate equivalent to 5.8 mg. Each Clorazepate Dipotassium Tablet, USP 15 mg contains clorazepate equivalent to 11.6 mg. Inactive ingredients for Clorazepate Dipotassium Tablets, USP: Colloidal Silicon Dioxide, FD&C Blue No.2 Aluminum Lake (3.75 mg), FD&C Yellow No.6 Aluminum Lake (7.5 mg), Magnesium Oxide, Potassium Chloride, Potassium Carbonate, Microcrystalline Cellulose, Croscarmellose Sodium and Magnesium Stearate. structure

The active ingredient in colestipol hydrochloride tablets USP is micronized colestipol hydrochloride, which is a lipid lowering agent for oral use. Colestipol is an insoluble, high molecular weight basic anion-exchange copolymer of diethylenetriamine and 1-chloro-2, 3-epoxypropane, with approximately 1 out of 5 amine nitrogens protonated (chloride form). It is a light yellow water-insoluble resin which is hygroscopic and swells when suspended in water or aqueous fluids. Each colestipol hydrochloride tablet USP contains one gram of micronized colestipol hydrochloride. Colestipol hydrochloride tablets are yellow in color and are tasteless and odorless. Inactive ingredients: acetone, cellulose acetate phthalate, ethanol, magnesium stearate, microcrystalline cellulose, hypromellose, povidone, silicon dioxide and triacetin.

Hydrocortisone is a white to practically white, odorless, crystalline powder, very slightly soluble in water. It has the chemical name Pregn-4-ene-3,20-dione,11,17,21-trihydroxy,(11β)-and the following structural formula: CORTENEMA® is a convenient disposable single-dose hydrocortisone enema designed for ease of self-administration. Each disposable unit (60 mL) contains: Hydrocortisone, 100 mg in an aqueous solution containing carbomer 934P, polysorbate 80, purified water, sodium hydroxide and methylparaben, 0.18% as a preservative. Chemical Structure

Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS), is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white to yellow crystalline powder. Sparingly soluble in alcohol; Soluble in acetone and in dilute mineral acids; practically insoluble in water. Dapsone is issued on prescription in tablets of 25 and 100 mg for oral use. Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate and Microcrystalline Cellulose. USP Dissolution Test Pending. STRUCTURE

Dexamethasone Tablets, USP for oral administration, are supplied in the following potencies, 0.5 mg, 0.75 mg, 1.5 mg, 2 mg, 4 mg and 6 mg. Inactive ingredients are Microcrystalline Cellulose, Lactose Anhydrous, Croscarmellose Sodium, Magnesium Stearate, FD&C Blue #1 Aluminum Lake (0.75 mg, 4 mg, 6 mg), D&C Red #27 Aluminum Lake (1.5 mg), FD&C Red #40 Aluminum Lake (1.5 mg), FD&C Yellow #6 Aluminum Lake (0.5 mg), D&C Yellow #10 Aluminum Lake (0.5 mg, 0.75 mg, 1.5 mg, 4 mg, 6 mg). The molecular weight for dexamethasone is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The empirical formula is C22H29FO5 and the structural formula is Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. FDA approved dissolution test specifications differ from USP. structure

Each 5 mL (teaspoonful) contains: Dexamethasone, USP……………………………….. 0.5 mg Also contains: Benzoic Acid, USP…………………………………. 0.1% (as a preservative) Alcohol………………………………………………5% Inactive Ingredients: Artificial raspberry flavor, citric acid, edetate disodium, FD&C Red #40, propylene glycol, purified water, saccharin sodium, sorbitol solution. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. The molecular weight is 392 . 47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The molecular formula is C 22 H 29 FO 5 and the structural formula is: structure

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules contain equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength extended release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules contain drug-containing beads, which prolong the release of amphetamine compared to the dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate (immediate-release) tablet formulation. Each capsule contains: Capsule Strength 5 mg 10 mg 15 mg 20 mg 25 mg 30 mg Dextroamphetamine Saccharate 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg Amphetamine (D,L)-Aspartate Monohydrate 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg Dextroamphetamine Sulfate 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg Amphetamine Sulfate 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg Total amphetamine base equivalence 3.1 mg 6.3 mg 9.4 mg 12.5 mg 15.6 mg 18.8 mg d- amphetamine base equivalence 2.4 mg 4.7 mg 7.1 mg 9.5 mg 11.9 mg 14.2 mg l- amphetamine base equivalence 0.75 mg 1.5 mg 2.3 mg 3.0 mg 3.8 mg 4.5 mg Inactive Ingredients and Colors The inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules include: hard gelatin capsules, glyceryl monostearate, hypromellose, methacrylic acid copolymer dispersion, microcrystalline cellulose, polysorbate 80, talc, titanium dioxide, triacetin, triethyl citrate, and yellow iron oxide. The hard gelatin capsules contain: gelatin, titanium dioxide and FD&C red #40. The 5 mg, 10 mg, and 15 mg capsules also contain FD&C green #3 and D&C yellow #10. The printing on the capsules uses edible inks containing: shellac, potassium hydroxide and black iron oxide.

Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata . The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[( O -2,6-dideoxy-β- D-ribo -hexopyranosyl-(1→4)- O - 2,6-dideoxy-β- D-ribo- hexopyranosyl-(1→4)-2,6-dideoxy-β- D - ribo -hexopyranosyl)oxy]-12,14- dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is: Digoxin exists as white or almost white powder or colorless crystals. The drug is practically insoluble in water; soluble in mixture of methanol & methylene chloride and slightly soluble in ethyl alcohol. Digoxin is supplied as 62.5 mcg (unscored), 125 mcg (scored), and 250 mcg (scored) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, lactose anhydrous, magnesium stearate. Additionally, the 62.5 mcg tablets contain FD&C Yellow No. 6 and 125 mcg tablets contain yellow iron oxide. Meets USP Dissolution Test 2. structure

Each Diphenoxylate Hydrochloride and Atropine Sulfate Tablet USP contains: 2.5 mg of diphenoxylate hydrochloride USP (equivalent to 2.3 mg of diphenoxylate) and 0.025 mg of atropine sulfate USP (equivalent to 0.01 mg of atropine) Diphenoxylate hydrochloride, an antidiarrheal, is ethyl 1-(3-cyano-3,3-diphenylpropyl)-4-phenylisonipecotate monohydrochloride and has the following structural formula: Atropine sulfate, an anticholinergic, is endo-(±)-α-(hydroxymethyl) benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1] oct-3-yl ester sulfate (2:1) (salt) monohydrate and has the following structural formula: A subtherapeutic amount of atropine sulfate is present to discourage deliberate overdosage. Each diphenoxylate hydrochloride and atropine sulfate tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate. Diphen-structure.jpg Atrop-structure.jpg

Erythromycin 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. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). The molecular formula is C 43 H 75 NO 16 and the molecular weight is 862.06. The structural formula is: Erythromycin Ethylsuccinate for Oral Suspension USP, 200 mg/5 mL when reconstituted with water, forms a suspension containing erythromycin ethylsuccinate equivalent to 200 mg erythromycin per 5 mL (teaspoonful) or 100 mg per 2.5 mL (dropperful) with an appealing cherry flavor. Erythromycin Ethylsuccinate for Oral Suspension USP, 400 mg/5 mL when reconstituted with water, forms a suspension containing erythromycin ethylsuccinate equivalent to 400 mg of erythromycin per 5 mL (teaspoonful) with an appealing cherry flavor. These products are intended primarily for pediatric use but can also be used in adults. Inactive Ingredients Erythromycin Ethylsuccinate for Oral Suspension USP, 200 mg/5 mL and 400 mg/5 mL contain the following inactive ingredients: lactose anhydrous, methylparaben, sodium citrate anhydrous, povidone, simethicone, cherry flavor, polysorbate 80, and sucrose. structure

Erythromycin 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. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). The molecular formula is C 43 H 75 NO 16 and the molecular weight is 862.06. The structural formula is: The granules are intended for reconstitution with water. Each 5 mL teaspoonful of reconstituted palatable cherry-flavored suspension contains erythromycin ethylsuccinate equivalent to 200 mg of erythromycin. Granules are intended primarily for pediatric use but can also be used in adults. Inactive Ingredients: artificial cherry flavor, lactose anhydrous, methylparaben, polysorbate 80, povidone, simethicone, sodium citrate anhydrous, and sucrose. structure

Esterified Estrogens and Methyltestosterone Tablets: Each dark green, capsule shaped, sugar-coated oral tablet imprinted with “1490” contains: 1.25 mg of Esterified Estrogens, USP and 2.5 mg of Methyltestosterone, USP. Esterified Estrogens and Methyltestosterone Half-Strength Tablets: Each light green, capsule shaped, sugar-coated oral tablet imprinted with “1507” contains: 0.625 mg of Esterified Estrogens, USP and 1.25 mg of Methyltestosterone, USP. Esterified Estrogens Esterified Estrogens, USP is a mixture of the sodium salts of the sulfate esters of the estrogenic substances, principally estrone, that are of the type excreted by pregnant mares. Esterified Estrogens contain not less than 75.0 percent and not more than 85.0 percent of sodium estrone sulfate, and not less than 6.0 percent and not more than 15.0 percent of sodium equilin sulfate, in such proportion that the total of these two components is not less than 90.0 percent. Methyltestosterone Methyltestosterone, USP is an androgen. Androgens are derivatives of cyclopentano-perhydrophenanthrene. Endogenous androgens are C-19 steroids with a side chain at C-17, and with two angular methyl groups. Testosterone is the primary endogenous androgen. Fluoxymesterone and methyltestosterone are synthetic derivatives of testosterone. Methyltestosterone is a white to light yellow crystalline substance that is virtually insoluble in water but soluble in organic solvents. It is stable in air but decomposes in light. Methyltestosterone structural formula: Esterified Estrogens and Methyltestosterone Full and Half-Strength Tablets contain the following inactive ingredients: acacia, calcium carbonate, carnauba wax, citric acid, colloidal silicon dioxide, di-acetylated monoglycerides, gelatin, lactose, magnesium stearate, methylparaben, microcrystalline cellulose, pharmaceutical glaze, povidone, propylene glycol, propylparaben, shellac glaze, sodium benzoate, sodium bicarbonate, sorbic acid, starch, sucrose, talc, titanium dioxide, tromethamol, FD&C Blue No. 1 Aluminum Lake, and D&C Yellow No. 10 Aluminum Lake. Esterified Estrogens and Methyltestosterone Tablets also contain: FD&C Yellow No. 6 Aluminum Lake. Esterified Estrogens and Methyltestosterone Half-Strength Tablets also contain: FD&C Blue No. 2 Aluminum Lake and Iron Oxide Black. 21328e7b-figure-01

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 to practically white powder, 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, microcrystalline cellulose, 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 D&C yellow no. 10 aluminum lake. FDA approved dissolution test specifications differ from USP. structure

Estradiol Gel, 0.1% is a clear, colorless smooth gel, free from visible particulate matter. It is designed to deliver sustained circulating concentrations of estradiol when applied once daily to the skin. The gel is applied to a small area (200 cm 2 ) of the thigh in a thin layer. Estradiol gel is available in five doses of 0.25, 0.5, 0.75, 1.0, and 1.25 grams for topical application (corresponding to 0.25, 0.5, 0.75, 1.0, and 1.25 mg estradiol, respectively). The active component of the topical gel is estradiol, an estrogen. Estradiol is a white crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17ß-diol. It has an empirical formula of C 18 H 24 O 2 and molecular weight of 272.39. The structural formula is: The remaining components of the gel (carbomer, alcohol [62%], propylene glycol, purified water, and trolamine) are pharmacologically inactive. structure

Estradiol gel contains 0.06 percent estradiol in an absorptive hydroalcoholic gel base for topical application. It is a clear, colorless hydroalcoholic gel. One pump depression of estradiol gel delivers 1.25 g of gel containing 0.75 mg estradiol. Estradiol is a white crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17β-diol. It has an empirical formula of C 18 H 24 O 2 and molecular weight of 272.39. The structural formula is: The active component of the gel is estradiol. The remaining components of the gel (purified water, alcohol (46%), triethanolamine and carbomer 974P) are pharmacologically inactive. structure

Etodolac is a member of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each capsule contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac 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. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol:water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C 17 H 21 NO 3 , and it has the following structural formula: Each capsule, for oral administration, contains 200 mg or 300 mg of etodolac USP. The inactive ingredients in Etodolac Capsules USP include: lactose monohydrate, povidone, sodium starch glycolate, sodium lauryl sulfate, propylene glycol, colloidal silicon dioxide, magnesium stearate, talc, titanium dioxide, gelatin, D&C Red No. 28, D&C Red No. 33, FD&C Red No. 40, D&C Yellow No. 10, FD&C Blue No. 1, shellac, and black iron oxide. structure

The active ingredient in famotidine for oral suspension USP is a histamine-2 (H2) receptor antagonist. Famotidine is N' -(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4- thiazolyl]methyl]thio] propanimidamide. The empirical formula of famotidine is C 8 H 15 N 7 O 2 S 3 and its molecular weight is 337.45. Its structural formula is: Each 5 mL of Famotidine for Oral Suspension USP, when prepared as directed contains 40 mg of famotidine and the following inactive ingredients: citric acid anhydrous, microcrystalline cellulose, carboxymethylcellulose sodium, sucrose, xanthan gum, banana and cherry flavor. Added as preservatives are methylparaben sodium, propylparaben sodium and sodium benzoate. Famotidine is a white to pale yellowish-white crystalline powder that is freely soluble in dimethyl formamide and glacial acetic acid; slightly soluble in methanol; very slightly soluble in water; and practically insoluble in chloroform, ether and ethyl acetate. structure

Felbamate USP is an antiepileptic available as 400 mg and 600 mg tablets for oral administration. Its chemical name is 2-phenyl-1,3-propanediol dicarbamate. Felbamate USP is a white to off-white crystalline powder with a characteristic odor. It is very slightly soluble in water, slightly soluble in ethanol, sparingly soluble in methanol, and freely soluble in dimethyl sulfoxide. The molecular weight is 238.24; felbamate's molecular formula is C 11 H 14 N 2 O 4 ; its structural formula is: The inactive ingredients for Felbamate Tablets USP, 400 mg and 600 mg are: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and iron oxide yellow. structural formula

Fenofibrate Capsules USP (Micronized) are lipid regulating agent available as capsules for oral administration. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula: The empirical formula is C 20 H 21 O 4 Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79 to 82°C. Fenofibrate USP is a white solid which is stable under ordinary conditions. Each 67 mg Fenofibrate Capsule (Micronized) contain the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, sodium lauryl sulfate, talc, FD&C Blue 1, FD&C Red 33, D&C Yellow 10, titanium dioxide and gelatin. Imprinting ink contains shellac, potassium hydroxide, propylene glycol and black iron oxide. Each 134 mg Fenofibrate Capsule (Micronized) contain the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, sodium lauryl sulfate, talc, FD&C Blue 1, D&C Red 3, titanium dioxide and gelatin. Imprinting ink contains shellac, potassium hydroxide and propylene glycol. Each 200 mg Fenofibrate Capsule (Micronized) contain the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, sodium lauryl sulfate, talc, iron oxide red, iron oxide yellow, titanium dioxide and gelatin. Imprinting ink contains shellac, potassium hydroxide, propylene glycol and black iron oxide. molecular-structure