actavis pharma, inc. - Medication Listings

Lisinopril, USP is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C 21 H 31 N 3 O 5 2H 2 O and its structural formula is: Lisinopril, USP is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets, USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Each tablet for oral administration contains 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, or 40 mg of lisinopril. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate, FD&C Blue #2 Aluminum Lake (10 mg only), FD&C Yellow #5 (tartrazine) Aluminum Lake (20 mg, 30 mg, and 40 mg, only), magnesium stearate, mannitol, pregelatinized starch. Lisinopril, USP is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is:

Metoprolol succinate, USP is a beta 1 -selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate, USP in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.83, 47.66, 95.33 and 190.65 mg of metoprolol succinate, USP equivalent to 25 mg, 50 mg, 100 mg and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is: Metoprolol succinate, USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether, and heptane. Inactive ingredients: acetyltributyl citrate, colloidal silicon dioxide, crospovidone, ethylcellulose, hypromellose 2910, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polysorbate 80, polyethylene glycol 400, polyethylene glycol 6000, polyethylene glycol 8000, talc and titanium dioxide. FDA approved dissolution test specifications differ from the USP. 1

The active ingredient in gabapentin capsules, USP is gabapentin, USP which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin, USP is C 9 H 17 NO 2 and the molecular weight is 171.24. The structural formula of gabapentin, USP is: Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 3.7 and a pK a2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.25. Each gabapentin capsule contains 100 mg, 300 mg, or 400 mg of gabapentin, USP and the following inactive ingredients: black iron oxide, corn starch, 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, mannitol, red iron oxide, shellac, talc, titanium dioxide, yellow iron oxide and may contain propylene glycol and sodium lauryl sulfate. 1

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: C 7 H 8 ClN 3 O 4 S 2 M.W. 297.74 Hydrochlorothiazide, USP is a white, or practically white, crystalline powder, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Each tablet for oral administration contains 12.5 mg of hydrochlorothiazide, USP. In addition, each tablet contains the following inactive ingredients: calcium stearate, corn starch, FD&C Yellow #6 (Sunset Yellow), lactose monohydrate, pregelatinized starch, sodium lauryl sulfate, and stearic acid. 582023b7-figure-01

Hydrochlorothiazide Capsules, USP, 12.5 mg is the 3,4-dihydro derivative of chlorothiazide. Its chemical name 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 ; its molecular weight is 297.74; and its structural formula is: It is a white, or practically white, crystalline powder which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Hydrochlorothiazide is supplied as 12.5 mg capsules for oral use. Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate. Gelatin capsules contain D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1, gelatin, titanium dioxide. The capsules are printed with edible ink containing black iron oxide, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Red No. 40. Hydrochlorothiazide Capsules, USP, 12.5 mg is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2; its molecular weight is 297.74; and its structural formula is:

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 monohydrate, 17,21-dihydroxy-. The structural formula is represented below: C 21 H 26 O 5 M.W. 358.44 Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg of prednisone, USP (anhydrous). In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, docusate sodium, magnesium stearate and sodium benzoate. Prednisone tablets, USP 20 mg also contain FD&C Yellow No. 6. structural formula for prednisone

Celecoxib capsules are a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib, USP for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. It has the following chemical structure: C 17 H 14 F 3 N 3 O 2 S M.W. 381.38 Celecoxib, USP is a white to almost white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib, USP is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: black iron oxide, crospovidone, dehydrated alcohol, FD&C Blue No.1, gelatin, lactose monohydrate, magnesium stearate, povidone, shellac, sodium lauryl sulfate, and titanium dioxide. The 50 mg, 200 mg and 400 mg capsules also contain D&C Yellow No. 10. The 50 mg, 100 mg and 200 mg capsules also contain D&C Red No. 28. The 400 mg capsule also contains FD&C Yellow No. 6. the chemical structure of Celecoxib capsules are a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38.

Triamterene and hydrochlorothiazide tablets, USP combine triamterene USP, a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide, USP. Triamterene and hydrochlorothiazide tablets, USP are available in two strengths. Each triamterene and hydrochlorothiazide tablet USP, 75 mg/50 mg, contains triamterene USP, 75 mg and hydrochlorothiazide USP, 50 mg. Each triamterene and hydrochlorothiazide tablet USP, 37.5 mg/25 mg, contains triamterene USP, 37.5 mg and hydrochlorothiazide USP, 25 mg. Both strengths of triamterene and hydrochlorothiazide tablets, USP for oral administration contain the following inactive ingredients: anhydrous lactose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol 8000, and povidone. Triamterene and hydrochlorothiazide tablets, 37.5 mg/25 mg also contain FD&C Blue No. 2 Aluminum Lake. Triamterene, USP is 2,4,7-triamino-6-phenylpteridine. Triamterene, USP is practically insoluble in water, benzene, chloroform, ether and dilute alkali hydroxides. It is soluble in formic acid and sparingly soluble in methoxyethanol. Triamterene, USP is very slightly soluble in acetic acid, alcohol and dilute mineral acids. Its molecular weight is 253.27. Its structural formula is: C 12 H 11 N 7 Triamterene, USP Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide, USP is slightly soluble in water and freely soluble in sodium hydroxide solution, n-butylamine and dimethylformamide. It is sparingly soluble in methanol and insoluble in ether, chloroform and dilute mineral acids. Its molecular weight is 297.73. Its structural formula is: C 7 H 8 ClN 3 O 4 S 2 Hydrochlorothiazide, USP 1 1

The active ingredient in Ibuprofen Oral Suspension, USP is ibuprofen, USP which is a member of the propionic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Ibuprofen, USP is a racemic mixture of [+]S- and [-]R-enantiomers. It is a white to off-white crystalline powder, with a melting point of 74° to 77°C. It is practically insoluble in water (<0.1 mg/mL), but readily soluble in organic solvents such as ethanol and acetone. Ibuprofen, USP has a pKa of 4.43 ± 0.03 and an n-octanol/water partition coefficient of 11.7 at pH 7.4. The chemical name for ibuprofen, USP is (±)-2 - ( p -Isobutylphenyl) propionic acid. The molecular weight of ibuprofen, USP is 206.28. Its molecular formula is C 13 H 18 O 2 and it has the following structural formula: Ibuprofen Oral Suspension, USP is a sucrose-sweetened, orange-colored, berry-flavored suspension containing 100 mg of ibuprofen, USP in 5 mL (20 mg/mL). Inactive ingredients include: acesulfame potassium, citric acid anhydrous, D&C yellow #10, FD&C red #40, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, strawberry flavor, sucrose and xanthan gum. 1c1b5c78-figure-01

Sildenafil for oral suspension, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA ® (sildenafil tablets USP) for erectile dysfunction. Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H -pyrazolo [4,3- d ] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula: Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water. Sildenafil for oral suspension is supplied as white to off-white powder containing 1.57 g of sildenafil citrate, USP (equivalent to 1.12 g sildenafil) in an amber glass bottle intended for reconstitution. Following reconstitution with 90 mL water, the total volume of the oral suspension is 112 mL and the oral suspension contains 10 mg/mL sildenafil. The inactive ingredients include anhydrous citric acid, colloidal silicon dioxide, grape flavor, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, titanium dioxide, and xanthan gum. In addition to the bottle, a press-in bottle adapter and an oral dosing syringe (with 0.5 mL and 2 mL dose markings) are provided. formula

Clarithromycin, USP is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6-0­ methylerythromycin. The molecular formula is C 38 H 69 NO 13 , and the molecular weight is 747.95. The structural formula is: Figure 1: Structure of Clarithromycin Clarithromycin, USP is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Each yellow oval film-coated unscored clarithromycin extended-release tablet, for oral administration, contains 500 mg of clarithromycin and the following inactive ingredients: compressible sugar, D&C yellow #10 Aluminum Lake, glycerol monostearate, polyethylene glycol 3000, polyvinyl alcohol, sodium phosphate monobasic (anhydrous), talc and titanium dioxide. FDA approved dissolution test specifications differ from USP. 2

Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-( S )- N -methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The structural formula is: C 18 H 19 NOS•HCl M.W. 333.88 Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride, USP equivalent to 20 mg, 30 mg, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include black iron oxide, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, potassium hydroxide, propylene glycol, shellac, strong ammonia solution, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. The 20 mg and 30 mg capsules also contain FD&C Blue #1 Aluminum Lake. 1

Buprenorphine sublingual tablets are uncoated orange oval tablets, imprinted with a logo on one side and a numeric imprint on the other side. The tablets contain buprenorphine HCl, USP and are available in two dosage strengths, 2 mg buprenorphine and 8 mg buprenorphine (as the free base). Each tablet also contains citric acid anhydrous, crospovidone, FD&C Yellow #6 HT Aluminum Lake, lactose monohydrate, magnesium stearate, mannitol, pregelatinized starch (maize), povidone, sodium citrate dihydrate. Chemically, buprenorphine HCl, USP is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure: Buprenorphine HCl, USP has the molecular formula C 2 9 H 4 1 NO 4 •HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol and practically insoluble in cyclohexane. The following chemical structure for Buprenorphine HCl, USP has the molecular formula C29 H41 NO4 • HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol and practically insoluble in cyclohexane.

Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Acyclovir Ointment 5% is a formulation for topical administration. Each gram of Acyclovir Ointment 5% contains 50 mg of acyclovir in a polyethylene glycol (PEG) base. Acyclovir is a white to off-white crystalline powder with the molecular formula C 8 H 11 N 5 O 3 and a molecular weight of 225.20. 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]-6 H -purin-6-one; it has the following structural formula: Chemical Structure

Acyclovir is a synthetic nucleoside analogue active against herpes viruses. Acyclovir suspension is formulated for oral administration. Each teaspoonful (5 mL) of acyclovir oral suspension, USP contains 200 mg of acyclovir and the inactive ingredients carboxymethylcellulose sodium, flavor, glycerin, methylparaben (0.1%), microcrystalline cellulose, propylparaben (0.02%), 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 225.20. 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 9-[(2-Hydroxyethoxy)methyl]guanine; 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 three 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 with 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 IC 50 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. 782d5d91-figure-01

Adapalene gel, 0.3% contains adapalene (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbomer 940, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C 28 H 28 O 3 and molecular weight is 412.53. Adapalene is represented by the following structural formula. 1

Albendazole, USP is an orally administered anthelmintic drug. Chemically, it is methyl 5-(propylthio)-2-benzimidazolecarbamate. Its molecular formula is C 12 H 15 N 3 O 2 S. Its molecular weight is 265.34. It has the following chemical structure: Albendazole, USP is a white to faintly yellowish powder. It is freely soluble in anhydrous formic acid; very slightly soluble in ether and in methylene chloride; practically insoluble in alcohol and in water. Each white to off-white, film-coated, unscored tablet contains 200 mg of albendazole, USP. Inactive ingredients consist of: corn starch, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400 and 8000, povidone, sodium lauryl sulfate, sodium starch glycolate type A, and sucralose. formula

Allopurinol, USP is a xanthine oxidase inhibitor. It has the following structural formula: Allopurinol, USP is known chemically as 1, 5-dihydro-4 H -pyrazolo [3, 4- d ]pyrimidin-4-one and it has a molecular weight of 136.11 g/mol. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. It is a xanthine oxidase inhibitor which is administered orally. Allopurinol Tablets USP, 100 mg and 300 mg contain the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized corn starch and sodium lauryl sulfate. In addition, the 300 mg strength also contains FD&C Yellow No. 6. structure

The active ingredient in alosetron hydrochloride tablets is alosetron hydrochloride (HCl), a potent and selective antagonist of the serotonin 5-HT 3 receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, monohydrochloride. Alosetron is achiral and has the empirical formula C 17 H 18 N 4 O•HCl, representing a molecular weight of 330.8. Alosetron is a white to beige solid that has a solubility of 61 mg/mL in water, 42 mg/mL in 0.1M hydrochloric acid, 0.3 mg/mL in pH 6 phosphate buffer, and <0.1 mg/mL in pH 8 phosphate buffer. The chemical structure of alosetron is: Alosetron hydrochloride tablets are supplied for oral administration as 0.5 mg (white) and 1 mg (blue) tablets. The 0.5 mg tablet contains 0.562 mg alosetron HCl equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron HCl equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film coat for the 0.5 mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film coat for the 1 mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine. Chemical Structure

Alprazolam tablets, USP contain alprazolam, USP which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam, USP is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is: C 17 H 13 CIN 4 M.W. 308.76 Alprazolam, USP is a white to off-white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each tablet, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam, USP. The 2 mg tablets are multi-scored and may be divided in half to provide two 1 mg segments, or quarters to provide four 0.5 mg segments. Inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium benzoate. The 0.5 mg tablet also contains FD&C Yellow #6 Aluminum Lake (Sunset Yellow Lake). The 1 mg tablet also contains FD&C Blue #2 Aluminum Lake. The 2 mg tablet also contains D&C Yellow #10 Aluminum Lake. 1

Alprazolam orally disintegrating tablets, USP contain alprazolam, USP which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. Alprazolam orally disintegrating tablets, USP are an orally administered formulation of alprazolam, USP which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing. The chemical name of alprazolam, USP is 8-Chloro-1-methyl-6-phenyl-4H- s -triazolo [4,3-α] [1,4] benzodiazepine. The molecular formula is C 17 H 13 CIN 4 and the molecular weight is 308.76. The structural formula is: Alprazolam, USP is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. The structural formula of is alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The molecular formula is C17H13CIN4 and the molecular weight is 308.76. 11.1 Alprazolam Orally Disintegrating Tablets Each orally disintegrating tablet contains either 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam, USP and the following inactive ingredients: corn starch, crospovidone, magnesium stearate, mannitol, methacrylic acid copolymer (type C), microcrystalline cellulose, natural and artificial orange flavor, polysorbate 80, sodium lauryl sulfate, sucralose. In addition, the 1 mg and 2 mg tablets contain ferric oxide (yellow 10 synthetic yellow iron oxide). Product meets USP Dissolution Test 2. Product meets USP Disintegration Test 2.

Alprazolam extended-release tablets, USP contain alprazolam, USP 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-4 H - s -triazolo [4,3-α] [1,4] benzodiazepine. The molecular formula is C 17 H 13 ClN 4 which corresponds to a molecular weight of 308.76. The structural formula is represented below: Alprazolam, USP 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 extended-release tablet USP, for oral administration, contains 0.5 mg, 1 mg, 2 mg, or 3 mg of alprazolam, USP. The inactive ingredients are lactose monohydrate, hypromellose, and magnesium stearate. In addition, the 1 mg tablets also contain D&C yellow #10 aluminum lake. The 2 mg tablets also contain FD&C Yellow #6 aluminum lake, and the 3 mg tablets also contain D&C Yellow #10 aluminum lake, and FD&C Blue #2 aluminum lake. Product meets USP Dissolution Test 2. 1

Alvimopan capsules contain alvimopan, an opioid antagonist. Chemically, alvimopan is the single stereoisomer [[2(S)-[[4( R )-(3-hydroxyphenyl)-3( R ),4-dimethyl-1-piperidinyl]methyl]-1-oxo-3-phenylpropyl]amino]acetic acid dihydrate. It has the following structural formula: Alvimopan is a white to light beige powder with a molecular weight of 460.54, and the empirical formula is C 25 H 32 N 2 O 4 •2H 2 O. It has a solubility of <0.1 mg/mL in water or buffered solutions between pH 3.0 and 9.0, 1 to 5 mg/mL in buffered solutions at pH 1.2, and 10 to 25 mg/mL in aqueous 0.1 N sodium hydroxide. At physiological pH, alvimopan is zwitterionic, a property that contributes to its low solubility. Alvimopan capsules for oral administration contain 12 mg of alvimopan on an anhydrous basis suspended in the inactive ingredient polyethylene glycol 3350. The capsule shell contains gelatin, sodium lauryl sulfate, and titanium dioxide. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. 1

Amantadine hydrochloride, USP is designated generically as amantadine hydrochloride, USP and chemically as 1-adamantanamine hydrochloride. Amantadine hydrochloride, USP is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride, USP has pharmacological actions as both an anti-Parkinson and an antiviral drug. Each tablet intended for oral administration contains 100 mg amantadine hydrochloride, USP and has the following inactive ingredients: microcrystalline cellulose, povidone, sodium starch glycolate, magnesium stearate and colloidal silicon dioxide. structural formula

Ambrisentan is an endothelin receptor antagonist. The chemical name of ambrisentan is (+)-(2 S )-2-[(4,6-dimethylpyrimidin-2-yl)oxy]-3-methoxy-3,3-diphenylpropanoic acid. It has a molecular formula of C 22 H 22 N 2 O 4 and a molecular weight of 378.42 and has the following structural formula: Figure 1: Ambrisentan Structural Formula Ambrisentan is a white to light yellow, crystalline powder. It is a carboxylic acid with a pKa of 4.0. Ambrisentan is practically insoluble in water and in aqueous solutions at low pH. Solubility increases in aqueous solutions at higher pH. In the solid state ambrisentan is very stable, is not hygroscopic, and is not light sensitive. Ambrisentan is available as 5 mg and 10 mg film-coated tablets for once daily oral administration. The tablets include the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets are film-coated with a coating material containing lecithin, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Each 5 mg ambrisentan film-coated tablet is white to off-white and capsule shaped. Each 10 mg ambrisentan film-coated tablet is white to off-white and capsule shaped. Ambrisentan tablets are unscored. Figure 1 Ambrisentan Structural Formula

Amoxapine, USP is an antidepressant of the dibenzoxazepine class, chemically distinct from the dibenzazepines, dibenzocycloheptenes, and dibenzoxepines. It is designated chemically as 2-Chloro-11-(1-piperazinyl)dibenz[b,f][1,4]oxazepine. The structural formula is represented below: C 17 H 16 CIN 3 O M.W. 313.78 Amoxapine is supplied for oral administration as 25 mg, 50 mg, 100 mg and 150 mg tablets. Amoxapine tablets USP, 25 mg, 50 mg, 100 mg and 150 mg contain: dibasic calcium phosphate, magnesium stearate, pregelatinized (corn) starch, and stearic acid. Amoxapine tablets USP, 50 mg and 150 mg also contain: FD&C Yellow No. 6 Aluminum Lake. Amoxapine tablets USP, 100 mg also contain: FD&C Blue No. 2 Aluminum Lake. Amoxapine structural formula

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, USP is Benzeneacetamide, 4-[2’-hydroxy-3’-[(1-methylethyl)amino]propoxy]-. It has the following structural formula: C 14 H 22 N 2 O 3 M.W. 266.34 Atenolol, USP (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, USP is 2-Chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl) benzene sulfonamide. Chlorthalidone, USP has a water solubility of 12 mg/100 mL at 20°C. It has the following structural formula: C 14 H 11 ClN 2 O 4 S M.W. 338.77 Each atenolol and chlorthalidone tablet, USP 50 mg/25 mg for oral administration contains: atenolol USP, 50 mg and chlorthalidone USP, 25 mg. Each atenolol and chlorthalidone tablet, USP 100 mg/25 mg for oral administration contains: atenolol USP, 100 mg and chlorthalidone USP, 25 mg. Atenolol and chlorthalidone tablets USP, 50 mg/25 mg and 100 mg/25 mg, contain the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. 1 2

Azelaic acid gel 15%, is an aqueous gel which contains azelaic acid, a naturally-occurring saturated dicarboxylic acid. It is for topical use. Chemically, azelaic acid is 1,7-heptanedicarboxylic acid. The molecular formula for azelaic acid is C 9 H 16 O 4 . It has the following structure: Azelaic acid has a molecular weight of 188.22. It is a white, odorless crystalline solid. It is poorly soluble in water at 20°C (0.24%) but freely soluble in boiling water and in ethanol. Azelaic acid gel 15%, is a white to off-white homogeneous gel for topical use; each gram contains 0.15 gm azelaic acid (15% w/w) in an aqueous gel base containing benzoic acid (as a preservative), carbopol 980, edetate disodium, glycerol monooleate, lecithin, polysorbate 80, propylene glycol, purified water, and sodium hydroxide to adjust pH. 1

Betamethasone Dipropionate Ointment, USP (Augmented) contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for topical use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate, USP is the 17, 21-dipropionate ester of betamethasone. Chemically, betamethasone dipropionate, USP is 9-Fluoro-11β, 17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the molecular formula C 28 H 37 FO 7 , a molecular weight of 504 . 59 and the following structural formula: It is a white to creamy-white, odorless powder insoluble in water; freely soluble in acetone and in chloroform; sparingly soluble in alcohol. Each gram of Betamethasone Dipropionate Ointment, USP (augmented) 0 . 05% contains 0 . 643 mg betamethasone dipropionate, USP (equivalent to 0 . 5 mg betamethasone), in an off-white ointment base of propylene glycol, propylene glycol stearate, white petrolatum, and white wax. Chem struct

Betamethasone dipropionate cream contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has high corticosteroid activity and slight mineral-ocorticoid activity. Betamethasone dipropionate is the 17,21-dipropionate ester of betamethasone. Chemically, betamethasone dipropionate is 9-Fluoro-11 β, 17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C 28 H 37 FO 7 , a molecular weight of 504 . 6, and the following structural formula: Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. Each gram of betamethasone dipropionate cream 0 . 05% contains: 0 . 64 mg betamethasone dipropionate USP (equivalent to 0 . 5 mg betamethasone) in a hydrophilic cream base consisting of purified water, mineral oil, white petrolatum, polyoxyl 20 cetostearyl ether, cetostearyl alcohol, monobasic sodium phosphate, propylene glycol, phosphoric acid and/or sodium hydroxide for pH adjustment and chlorocresol as a preservative. 1

Betamethasone dipropionate ointment contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has high corticosteroid activity and slight mineralocorticoid activity. Betamethasone dipropionate is the 17, 21-dipropionate ester of betamethasone. Chemically, betamethasone dipropionate is 9-Fluoro-11 β, 17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C 28 H 37 FO 7 , a molecular weight of 504 . 6, and the following structural formula: Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. Each gram of betamethasone dipropionate ointment 0 . 05% contains: 0 . 64 mg betamethasone dipropionate, USP (equivalent to 0 . 5 mg betamethasone) in an ointment base consisting of mineral oil and white petrolatum. 14c51497-figure-01

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: butylated hydroxyanisole, polyethylene glycol 400, polysorbate 20, and povidone K30. The capsule shell contains gelatin, glycerin, sorbitol, and titanium dioxide. The imprinting ink contains black iron oxide, propylene glycol, and may also contain hypromellose 2910, and polyvinyl acetate phthalate. 1

Bosentan, an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)-[2,2´]-bipyrimidin-4-yl]-benzenesulfonamide monohydrate and has the following structural formula: C 27 H 29 N 5 O 6 S•H 2 O M.W. 569.64 Bosentan is a white to yellowish powder. It is poorly soluble in water (1.0 mg/100 mL) and in aqueous solutions at low pH (0.1 mg/100 mL at pH 1.1 and 4.0; 0.2 mg/100 mL at pH 5.0). Solubility increases at higher pH values (43 mg/100 mL at pH 7.5). In the solid state, bosentan is very stable, is not hygroscopic and is not light sensitive. Bosentan is available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contains the following excipients: corn starch, ethyl cellulose, glyceryl behenate, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, pregelatinized corn starch, povidone K90, sodium starch glycolate, titanium dioxide and triacetin. Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg of bosentan base. Each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate, equivalent to 125 mg of bosentan base. 1

Budesonide extended-release tablets, for oral administration, contain budesonide USP, a synthetic corticosteroid, as the active ingredient. Budesonide, USP is designated chemically as (RS)-11β, 16α, 17, 21 tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide, USP is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide, USP is C 25 H 34 O 6 and its molecular weight is 430.54. Its structural formula is: Budesonide, USP is a white to almost white, tasteless, odorless powder that is practically insoluble in water, sparingly soluble in alcohol, and freely soluble in chloroform. Budesonide extended-release, a delayed and extended-release tablet, is coated with a polymer film, which breaks down at or above pH 7. The tablet core contains budesonide with polymers that provide for extended-release of budesonide. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose 2910, iron oxide black, lactose monohydrate, magnesium stearate, methacrylic acid copolymer types A and B, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, propylene glycol, sodium starch glycolate Type A, soy lecithin powder, talc, titanium dioxide, and triethyl citrate. The structural formula for Budesonide

Buprenorphine and naloxone sublingual tablets, USP are uncoated white to off-white, round tablets, debossed with on one side and a numeric imprint identifying the product and strength on the other side. They contain buprenorphine hydrochloride USP, a partial agonist at the mu-opioid receptor, and naloxone hydrochloride dihydrate USP, an opioid receptor antagonist, at a ratio of 4:1 (ratio of free bases). They are intended for sublingual administration and are available in two dosage strengths, 2 mg buprenorphine with 0.5 mg naloxone and 8 mg buprenorphine with 2 mg naloxone. Each sublingual tablet also contains citric acid anhydrous, crospovidone, lactose monohydrate, magnesium stearate, mannitol, N&A lemon FL, pregelatinized starch (maize), povidone K-30, sodium citrate dihydrate, and sucralose. Chemically, buprenorphine HCl, USP is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure: Buprenorphine HCl, USP It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. Chemically, naloxone HCl dihydrate, USP is 17-Allyl-4,5α-epoxy-3, 14-dihydroxymorphinan-6-one hydrochloride dihydrate. It has the following chemical structure: Naloxone hydrochloride dihydrate, USP It is a white to slightly off-white powder and is freely soluble in water, soluble in alcohol, and practically insoluble in toluene and ether. round tablets 1 1

Bupropion hydrochloride extended-release tablets USP, (XL), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13 H 18 ClNO·HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is: Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 300 mg, off-white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: colloidal anhydrous silica, colloidal silicon dioxide, copovidone, hydroxypropyl cellulose, magnesium stearate, methacrylic acid copolymer type C, polyethylene glycol, polyvinyl alcohol, povidone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. This drug product conforms to USP Drug Dissolution Test #11. The structural formula Bupropion Hydrochloride.

Bupropion Hydrochloride Extended-release Tablets, USP (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1­ dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13 H 18 ClNO•HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is: Bupropion Hydrochloride Extended-release Tablets, USP (SR) are supplied for oral administration as 100 mg, 150 mg, and 200 mg white to off-white, film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the following inactive ingredients: hydroxypropyl cellulose, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, and magnesium stearate. The film coating contains lactose monohydrate, hydroxypropyl cellulose, titanium dioxide, and polyethylene glycol. Chemical Structure

Bupropion hydrochloride extended-release tablets, USP (SR) are a non-nicotine aid to smoking cessation. Bupropion hydrochloride extended-release tablets, USP (SR) are chemically unrelated to nicotine or other agents currently used in the treatment of nicotine addiction. Initially developed and marketed as an antidepressant (WELLBUTRIN ® [bupropion hydrochloride] tablets and WELLBUTRIN SR ® [bupropion hydrochloride] sustained-release tablets), bupropion hydrochloride extended-release tablets, USP (SR) are also chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13 H 18 ClNO•HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is: Bupropion hydrochloride extended-release tablets, USP (SR) are supplied for oral administration as 150 mg white to off-white, film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and stearic acid. The film-coating contains hydroxypropyl cellulose, lactose monohydrate, polyethylene glycol, and titanium dioxide. bupropion hydrochloride chemical structure

Bupropion hydrochloride extended-release tablets (XL), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13 H 18 ClNO•HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is: Bupropion hydrochloride extended-release tablets (XL) are supplied for oral administration as 150 mg, white to off-white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride, USP and the inactive ingredients: colloidal silicon dioxide, ethylcellulose, hydroxypropyl cellulose, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, stearic acid, talc, titanium dioxide, and triethyl citrate. The tablets are printed with edible black ink which consists of the following: hypromellose 2910, iron oxide black, and propylene glycol. Meets USP dissolution method 28. Structural formula

Butalbital, acetaminophen, and caffeine tablets USP is supplied in tablet form for oral administration. Each tablet contains the following active ingredients: butalbital USP……………………… 50 mg acetaminophen USP……………… 325 mg caffeine USP……………………… 40 mg Butalbital (5-allyl-5-isobutylbarbituric acid) is a short- to intermediate-acting barbiturate. It has the following structural formula: Acetaminophen (4´-hydroxyacetanilide) is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: Caffeine (1,3,7-trimethylxanthine) is a central nervous system stimulant. It has the following structural formula: Inactive Ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Butalbital Structural Formula Acetaminophen structural Formula Caffeine Structural Formula

Butalbital, Acetaminophen, and Caffeine Capsules, USP are supplied in hard-gelatin capsule form for oral administration. Each capsule contains the following active ingredients: Butalbital, USP……………………50 mg Acetaminophen, USP…………….300 mg Caffeine, USP……………………..40 mg Inactive Ingredients: sodium lauryl sulfate, talc, microcrystalline cellulose, stearic acid, FD&C red # 40, titanium dioxide, FD&C blue # 1, FD&C yellow # 6, gelatin. Butalbital (5-allyl-5-isobutylbarbituric acid) is a short- to intermediate-acting barbiturate. It has the following structural formula: Acetaminophen (4´-hydroxyacetanilide) is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: Caffeine (1,3,7-trimethylxanthine) is a central nervous system stimulant. It has the following structural formula: Butalbital SF Acetaminophen SF Caffeine SF

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are supplied in capsule form for oral administration. Each capsule contains: Butalbital, USP…………..........50 mg Acetaminophen, USP………...325 mg Caffeine, USP……………........40 mg Codeine phosphate, USP….......30 mg Butalbital (5-allyl-5-isobutylbarbituric acid), is a short-to intermediate-acting barbiturate. It has the following structural formula: Acetaminophen (4'hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: Caffeine (1,3,7trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula: Codeine phosphate (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate) is an opioid agonist. It has the following structural formula: Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch. Gelatin capsules contain D&C Red No. 33, FD&C Blue No. 1, gelatin, and titanium dioxide. The capsules are printed with edible inks containing D&C Red No. 7 Calcium Lake, FD&C Blue No. 1 Aluminum Lake, and titanium dioxide. chem-structure-but.jpg chem-structure-acet.jpg chem-structure-caff.jpg chem-structure-cod.jpg

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are supplied in capsule form for oral administration. Each capsule contains: Butalbital, USP…………..........50 mg Acetaminophen, USP………...300 mg Caffeine, USP……………........40 mg Codeine phosphate, USP….......30 mg Butalbital (5-allyl-5-isobutylbarbituric acid), is a short-to intermediate-acting barbiturate. It has the following structural formula: Acetaminophen (4'hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: Caffeine (1,3,7-trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula: Codeine phosphate (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate) is an opioid agonist. It has the following structural formula: Inactive Ingredients: FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, microcrystalline cellulose, stearic acid, sodium lauryl sulfate, talc, and titanium dioxide. Butalbital Structural Formula Acetaminophen Caffeine Codeine phosphate

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

Diltiazem hydrochloride, USP is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5 H )-one, 3-(acetyloxy)-5-[2-(dimethylamino) ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)- cis -. The chemical structure is: Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride, USP is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), or 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem). In addition, each capsule contains the following inactive ingredients: acetyltributyl citrate, ammonio methacrylate copolymer, black iron oxide, cornstarch, D&C Red No. 28, D&C Yellow No. 10, D&C Yellow No. 10 Aluminum Lake, ethylcellulose, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40, FD&C Red No. 40 Aluminum Lake, gelatin, magnesium stearate, methacrylic acid copolymer, propylene glycol, polysorbate 80, sucrose, talc, and titanium dioxide. The 180 mg and 240 mg capsules contain yellow iron oxide. In addition, the 240 mg capsule also contains red iron oxide. For oral administration. This drug meets USP Drug Release 9. Diltiazem hydrochloride chemical structure

Chlorzoxazone, USP is a centrally-acting skeletal muscle relaxant, available as tablets of 500 mg for oral administration. Its chemical name is 5-Chloro-2-benzoxazolinone, and its structural formula is: Chlorzoxazone, USP is a white or practically white, practically odorless, crystalline powder. Chlorzoxazone, USP is slightly soluble in water; sparingly soluble in alcohol, in isopropyl alcohol, and in methanol; soluble in solutions of alkali hydroxides and ammonia. Chlorzoxazone Tablets, USP contain the inactive ingredients docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellullose, pregelatinized starch, sodium benzoate, and sodium starch glycolate. chemical structure

Ciclopirox Shampoo 1% contains the synthetic antifungal agent, ciclopirox for topical use. Each gram (equivalent to 0.96 mL) of Ciclopirox Shampoo 1% contains 10 mg ciclopirox, USP in a shampoo base consisting of purified water USP, sodium laureth sulfate, disodium laureth sulfosuccinate, sodium chloride USP, and laureth-2. Ciclopirox Shampoo 1% is a colorless, translucent solution. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1 H )-pyridone, with the molecular formula C 12 H 17 NO 2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is: ac2cca62-figure-01

Clindamycin phosphate and benzoyl peroxide gel, 1.2%/2.5% is a combination product with two active ingredients in a white to off-white, opaque, smooth, aqueous gel formulation intended for topical use. Clindamycin phosphate, USP is a water-soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate, USP is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo- α -D-galactooctopyranoside 2 -(dihydrogen phosphate). The structural formula for clindamycin phosphate, USP is represented below: Clindamycin phosphate, USP: C 18 H 34 ClN 2 O 8 PS M.W. 504.97 Benzoyl peroxide, USP is an antibacterial and keratolytic agent. The structural formula for benzoyl peroxide, USP is represented below: Benzoyl peroxide, USP: C 14 H 10 O 4 M.W. 242.23 Clindamycin phosphate and benzoyl peroxide gel contains the following inactive ingredients: purified water, carbomer 980, propylene glycol, and potassium hydroxide. Each gram of clindamycin phosphate and benzoyl peroxide gel contains 1.2% of clindamycin phosphate, USP which is equivalent to 1% clindamycin. The structural formula for clindamycin phosphate. The structural formula for benzoyl peroxide.

Clindamycin phosphate and tretinoin gel 1.2% / 0.025%, is an antibiotic and retinoid combination gel product with two active ingredients. Clindamycin phosphate, USP is a water-soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate, USP is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans -4- propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo -α-D- galacto -octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate, USP is represented below: Clindamycin phosphate, USP: Molecular Formula: C 18 H 34 ClN 2 O 8 PS Molecular Weight: 504.97 The chemical name for tretinoin, USP is 3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8- nonatetraenoic acid (all- trans form). The structural formula for tretinoin, USP is represented below: Tretinoin, USP: Molecular Formula: C 20 H 28 O 2 Molecular Weight: 300.44 Clindamycin phosphate and tretinoin gel 1.2% / 0.025% contains the following inactive ingredients: anhydrous citric acid, butylated hydroxytoluene, edetate disodium, hydroxyethyl cellulose, glycerin, methylparaben, polysorbate 80, propylparaben, purified water, tromethamine and xanthan gum. 12f9b5a2-figure-01 12f9b5a2-figure-02

Clobetasol Propionate Lotion, 0.05% contains clobetasol propionate, USP, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate, USP is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β -methylpregna-1,4-diene-3,20-dione 17-propionate, with the molecular formula C 25 H 32 CIFO 5 , and a molecular weight of 466.98 (CAS Registry Number 25122-46-7). The following is the chemical structure: Clobetasol propionate, USP is a white to almost white crystalline powder that is practically insoluble in water. Each gram of Clobetasol Propionate Lotion, 0.05% contains 0.5 mg of clobetasol propionate, USP, in a white liquid composed of carbomer 940, hypromellose, mineral oil, polyoxyethylene glycol 300 isostearate, polysorbate 80, propylene glycol, purified water, and sodium hydroxide. fe4be46c-figure-01