amneal pharmaceuticals llc - Medication Listings

Sucralfate Oral Suspension contains sucralfate, USP and sucralfate is an α-D-glucopyranoside, β-D-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. Sucralfate Oral Suspension for oral administration contains 1 g of sucralfate, USP per 10 mL. Sucralfate Oral Suspension also contains: cherry flavor, colloidal silicon dioxide, FD&C Red #40, glycerin, methylcellulose, methylparaben, microcrystalline cellulose, purified water, simethicone emulsion, and sorbitol solution. Therapeutic category: antiulcer. Chemical Structure

Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole, USP and 160 mg trimethoprim, USP; in tablets, each containing 400 mg sulfamethoxazole, USP and 80 mg trimethoprim, USP for oral administration. Sulfamethoxazole is N 1 -(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10 H 11 N 3 O 3 S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula: Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14 H 18 N 4 O 3 . It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula: Inactive ingredients: Magnesium stearate, povidone, pregelatinized starch and sodium starch glycolate. lk uy

Telmisartan is a non-peptide angiotensin II receptor (type AT 1 ) antagonist. Telmisartan is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its molecular formula is C 33 H 30 N 4 O 2 , its molecular weight is 514.63, and its structural formula is: Telmisartan, USP is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Telmisartan, USP is available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan, USP. The tablets contain the following inactive ingredients: magnesium stearate, mannitol, meglumine, povidone, sodium hydroxide and talc. Telmisartan tablets, USP are hygroscopic and require protection from moisture. 239f7255-figure-01

Temozolomide, USP is an alkylating drug. The chemical name of temozolomide, USP is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]- as -tetrazine-8-carboxamide. The structural formula of temozolomide, USP is: The material is a white to light tan/light pink powder with a molecular formula of C 6 H 6 N 6 O 2 and a molecular weight of 194.15. The molecule is stable at acidic pH (< 5) and labile at pH > 7; hence temozolomide, USP can be administered orally. The prodrug, temozolomide, USP is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP: Each capsule for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide, USP. The inactive ingredients for temozolomide capsules, USP are as follows: colloidal silicon dioxide, ethyl alcohol, lactose anhydrous, sodium starch glycolate, stearic acid and tartaric acid. The body of the capsules are made of gelatin and titanium dioxide, and are white opaque color. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, n-butyl alcohol, propylene glycol and shellac. Temozolomide Capsules USP, 5 mg : The green cap contains FD&C Blue #2, gelatin, titanium dioxide and yellow iron oxide. Temozolomide Capsules USP, 20 mg : The yellow cap contains D&C Yellow #10, FD&C Yellow #6, gelatin and titanium dioxide. Temozolomide Capsules USP, 100 mg : The pink cap contains FD&C Blue #1, FD&C Red #3, FD&C Red #40, gelatin and titanium dioxide. Temozolomide Capsules USP, 140 mg : The blue cap contains FD&C Blue #1, gelatin and titanium dioxide. Temozolomide Capsules USP, 180 mg : The red cap contains FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. Temozolomide Capsules USP, 250 mg : The white cap contains gelatin and titanium dioxide. 1

TEPADINA (thiotepa) is an alkylating agent. TEPADINA (thiotepa) for injection is supplied as a non-pyrogenic, sterile lyophilized white powder for intravenous, intracavitary, or intravesical use after reconstitution and dilution. TEPADINA is available In a single-dose vial containing 15 mg thiotepa. After reconstitution with 1.5 mL of Sterile Water for Injection, each mL contains 10 mg thiotepa; In a single-dose vial containing 100 mg thiotepa. After reconstitution with 10 mL of Sterile Water for Injection, each mL contains 10 mg thiotepa; In a single-dose multichamber flexible bag containing 200 mg thiotepa and 200 mL 0.9% Sodium Chloride Injection; In a single-dose multichamber flexible bag containing 400 mg thiotepa and 400 mL 0.9% Sodium Chloride Injection; Thiotepa is a synthetic product with antitumor activity. The chemical name for thiotepa is Tris(1-aziridinyl)phosphine sulfide. Thiotepa has the following structural formula: Thiotepa has the molecular formula C 6 H 12 N 3 PS, and a molecular weight of 189.23, and it appears as fine, white crystalline flakes, with a melting range of 52°C to 57°C. It is soluble in water and organic solvents. When reconstituted with sterile water for injection, the resulting solution has a pH of approximately 5.5 to 7.5. Thiotepa is unstable in acid medium. Thiotepa Structure

Tigecycline for injection, USP is a tetracycline class antibacterial for intravenous infusion. The chemical name of tigecycline, USP is (4 S ,4a S ,5a R ,12a S )-9-[2-( tert -butylamino)acetamido]-4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide. The empirical formula is C 29 H 39 N 5 O 8 and the molecular weight is 585.65. The following represents the chemical structure of tigecycline, USP: Figure 1: Structure of Tigecycline Tigecycline, USP is an orange lyophilized sterile powder or cake. Each tigecycline for injection, USP single-dose 5 mL vial contains 50 mg tigecycline, USP lyophilized powder for reconstitution for intravenous infusion and 50 mg of L-Arginine. The pH is adjusted with hydrochloric acid, and if necessary sodium hydroxide. The product does not contain preservatives. structure

Tobramycin inhalation solution, USP is a tobramycin solution for inhalation. It is a sterile, clear, slightly yellow, non-pyrogenic, aqueous solution with the pH and salinity adjusted specifically for administration by a compressed air driven reusable nebulizer. The chemical formula for tobramycin is C 18 H 37 N 5 O 9 and the molecular weight is 467.52. Tobramycin is O-3-amino-3-deoxy-α- D-glucopyranosyl-(1→4)-O-[2,6-diamino-2,3,6- trideoxy-α-D- ribo -hexopyranosyl-(1→6)]-2-deoxy-L-streptamine. The structural formula for tobramycin is: Each single-dose 5 mL ampule contains 300 mg tobramycin, USP and 11.25 mg sodium chloride in sterile water for injection. Sulfuric acid and sodium hydroxide are added to adjust the pH to 6.0. Nitrogen is used for sparging. All ingredients meet USP requirements. The formulation contains no preservatives. 10

Tranexamic acid is trans -4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid is a white crystalline powder. The structural formula is Molecular Formula: C 8 H 15 NO 2 Molecular Weight: 157.2 Each mL of the sterile solution for intravenous injection contains 100 mg tranexamic acid and water for injection to 1 mL. The aqueous solution for injection has a pH of 6.5 to 8.0. 2

Triamcinolone acetonide injectable suspension, USP is a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THIS FORMULATION IS SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THIS FORMULATION IS NOT FOR INTRADERMAL INJECTION. Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, USP, with 0.65% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.75% carboxymethylcellulose sodium, and 0.04% polysorbate 80 in an aqueous suspension. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is: MW 434.50 Triamcinolone acetonide, USP occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is practically insoluble in water and very soluble in alcohol. 1

Triamcinolone acetonide injectable suspension, USP is a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THIS FORMULATION IS SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THIS FORMULATION IS NOT FOR INTRADERMAL INJECTION. Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, USP, with 0.65% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.75% carboxymethylcellulose sodium, and 0.04% polysorbate 80 in an aqueous suspension. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is: MW 434.50 Triamcinolone acetonide, USP occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is practically insoluble in water and very soluble in alcohol. chem structure

Triamcinolone acetonide injectable suspension, USP is a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THIS FORMULATION IS SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THIS FORMULATION IS NOT FOR INTRADERMAL INJECTION. Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, USP, with 0.65% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.75% carboxymethylcellulose sodium, and 0.04% polysorbate 80 in an aqueous suspension. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is: Triamcinolone acetonide, USP occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is practically insoluble in water and very soluble in alcohol. 1

Valsartan, USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT 1 receptor subtype. Valsartan is chemically described as N -(1-oxopentyl)- N -[[2'-(1 H -tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L­-valine. Its empirical formula is C 24 H 29 N 5 O 3 , its molecular weight is 435.5, and its structural formula is: Valsartan, USP is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan tablets, USP are available for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan, USP. The inactive ingredients of the tablets are colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxides (yellow, black and/or red), macrogol, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, talc and titanium dioxide. 1

Valsartan and hydrochlorothiazide tablets, USP are a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT 1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N -(1-oxopentyl)- N -[[2'-(1 H -tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-L-Valine. Its molecular formula is C 24 H 29 N 5 O 3 , its molecular weight is 435.52 g/mol, and its structural formula is: Valsartan, USP is almost white, hygroscopic powder. It is practically insoluble in water, freely soluble in anhydrous ethanol and sparingly soluble in methylene chloride. Hydrochlorothiazide, USP is a white or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, n -butylamine, and in dimethyl formamide; sparingly soluble in methanol; and insoluble in ether, chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its molecular formula is C 7 H 8 ClN 3 O 4 S 2 , its molecular weight is 297.74 g/mol, and its structural formula is: Valsartan and hydrochlorothiazide tablets, USP are formulated for oral administration to contain valsartan, USP and hydrochlorothiazide, USP 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg, and 320 mg/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide yellow, polyethylene glycol, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, talc and titanium dioxide. The 80 mg/12.5 mg tablets also contain FD&C Red No. 40 and ferrosoferric oxide. The 160 mg/12.5 mg tablets also contain iron oxide red. The 160 mg/25 mg tablets also contain iron oxide red and ferrosoferric oxide. The 320 mg/12.5 mg tablets also contain iron oxide red and ferrosoferric oxide. q r

Vasopressin is a polypeptide hormone. Vasopressin Injection, USP is a sterile, aqueous solution of synthetic arginine vasopressin for intravenous administration. The 1 mL solution contains vasopressin, USP 20 units/mL, water for injection, lactic acid and sodium lactate buffer adjusted to a pH of 3.5, and sodium hydroxide and/or hydrochloric acid may have been used for pH adjustment. The chemical name of vasopressin is L-cysteinyl-L-tyrosyl-L-phenylalanyl-L-glutaminyl-L-asparaginyl-L-cysteinyl-L-prolyl-L-arginyl-glycinamide (1→6)-disulfide. It is a white to off-white powder or flakes, and it is very soluble in water. The structural formula is: Molecular Formula: C 46 H 65 N 15 O 12 S 2 Molecular Weight: 1084.24 u One mg is equivalent to 554 units. 1

Verapamil hydrochloride is a calcium antagonist or slow-channel inhibitor. Verapamil hydrochloride injection, USP is a sterile, nonpyrogenic solution containing verapamil hydrochloride USP, 2.5 mg/mL and sodium chloride 8.5 mg/mL in water for injection. The solution contains no bacteriostat or antimicrobial agent and is intended for single-dose intravenous administration. May contain hydrochloric acid for pH adjustment; pH is 4.9 (4.0 to 6.5). The chemical name of verapamil hydrochloride is benzeneacetonitrile, α-[3-[{2-(3,4-dimethoxyphenyl)ethyl} methylamino] propyl]-3,4-dimethoxy-α-(1-methylethyl) monohydrochloride (±)-. Verapamil hydrochloride, USP is white or practically white crystalline powder. It is practically odorless and has a bitter taste with a molecular formula C 27 H 38 N 2 O 4 •HCl, and a molecular weight of 491.06 g/mol. It is soluble in water; freely soluble in chloroform; sparingly soluble in alcohol; practically insoluble in ether. It has the following structural formula: Verapamil hydrochloride is not chemically related to other antiarrhythmic drugs. 1

Voriconazole USP, an azole antifungal agent is available as a powder for oral suspension. The structural formula is: Voriconazole, USP is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1 H -1,2,4-triazol-1-yl)-2-butanol with an molecular formula of C 16 H 14 F 3 N 5 O and a molecular weight of 349.3. Voriconazole, USP drug substance is a white to light-colored powder. Voriconazole for Oral Suspension is a white to off-white powder providing a white to off-white orange-flavored suspension when reconstituted. Bottles containing 45 grams powder for oral suspension, which contain 3 g of voriconazole USP, are intended for reconstitution with water to produce a suspension containing 40 mg/mL voriconazole, USP. The inactive ingredients include anhydrous citric acid, colloidal silicon dioxide, natural and artificial orange flavor, sodium benzoate, sodium citrate, sucrose, titanium dioxide, and xanthan gum. 1dfe1c6b-figure-01

Crystalline warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. The chemical name of warfarin sodium is 3-(α-acetonylbenzyl)-4-hydroxycoumarin sodium salt, which is a racemic mixture of the R - and S -enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its empirical formula is C 19 H 15 NaO 4 , and its structural formula is represented by the following: Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Warfarin sodium tablets, USP (Crystalline) for oral use also contain: All strengths: Hydroxypropyl Cellulose, Lactose Monohydrate, Magnesium Stearate and Pregelatinized Starch 1 mg: D&C Red No. 6 Barium Lake 2 mg: FD&C Blue No. 2 Aluminum Lake and FD&C Red No. 40 Aluminum Lake 2-1/2 mg: D&C Yellow No. 10 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake 3 mg: FD&C Yellow No. 6 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake 4 mg: FD&C Blue No. 1 Aluminum Lake 5 mg: FD&C Yellow No. 6 Aluminum Lake 6 mg: FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake 7-1/2 mg: D&C Yellow No. 10 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake 10 mg: Dye-free 474ff828-figure-01

Yuvafem (estradiol vaginal inserts, USP), 10 mcg, are small, white, film-coated inserts containing 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol, USP. Each insert of Yuvafem, 10 mcg contains the following excipients: corn starch, hypromellose, lactose monohydrate and magnesium stearate. The film coating contains hypromellose and polyethylene glycol. Each Yuvafem vaginal insert is 6 mm in diameter and is placed in a disposable applicator. Each insert-filled applicator is packaged separately in a blister pack. Yuvafem are used intravaginally. When the insert comes in contact with the vaginal mucosa, estradiol, USP is released into the vagina. Estradiol hemihydrate is a white, almost white or colorless crystalline solid, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The chemical formula is C 18 H 24 O 2 • ½ H 2 O with a molecular weight of 281.4. The structural formula is: formula

ZAFEMY is a transdermal system with a contact surface area of 12.5 cm 2 . It contains 3.15 mg norelgestromin, USP (NGMN) and 0.289 mg ethinyl estradiol, USP (EE), and its delivery rate is approximately 150 mcg of NGMN, USP and 35 mcg of EE, USP per day. Systemic exposures (as measured by area under the curve [AUC] and steady-state concentration [C ss ]) of NGMN, USP and EE, USP during use of ZAFEMY are higher and the C max is lower than those produced by an oral contraceptive containing norgestimate, USP (NGM) 250 mcg / EE, USP 35 mcg [see Boxed Warning and Clinical Pharmacology (12.3) ] . ZAFEMY is a thin, matrix-type transdermal system consisting of three layers. The backing layer is composed of a tan backing consisting of pigmented polyethylene and polyester. It provides structural support and protects the middle adhesive layer from the environment. The middle layer contains polyisobutylene/polybutene adhesive, polybutene, crospovidone, oleyl alcohol and dipropylene glycol as inactive components. The active components in this layer are the hormones, NGMN, USP and EE, USP. The third layer is the release liner , which protects the adhesive layer during storage and is removed just prior to application. It is a transparent polyethylene terephthalate (PET) film with a silicone coating on the side that is in contact with the middle adhesive layer. The outside of the backing layer is printed with “Norelgestromin and Ethinyl Estradiol 150/35 mcg per day” in brown ink. The structural formulas of the components are: Norelgestromin, USP ethinyl estradiol, USP Molecular weight, NGMN, USP: 327.47 Molecular weight, EE, USP: 296.41 Chemical name for NGMN, USP: 18, 19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-,3-oxime,(17α) Chemical name for EE, USP: 19-Norpregna-1,3,5(10)-trien-20-yne-3, 17-diol,(17α) Structural Formula

ZOMIG ® (zolmitriptan) Nasal Spray contains zolmitriptan, which is a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D ) receptor agonist. Zolmitriptan is chemically designated as (S)-4-[[3-[2-(dimethylamino) ethyl]-1H-indol-5-yl]methyl]-2-oxazolidinone and has the following chemical structure: The empirical formula is C 16 H 21 N 3 O 2 , representing a molecular weight of 287.36. Zolmitriptan is a white to almost white powder that is readily soluble in water. ZOMIG Nasal Spray is supplied as a clear to pale yellow solution of zolmitriptan, buffered to a pH 5.0. Each ZOMIG Nasal Spray contains 2.5 mg or 5 mg of zolmitriptan in a 100-μL unit dose aqueous buffered solution containing citric acid, anhydrous, USP, disodium phosphate dodecahydrate USP and purified water USP. ZOMIG Nasal Spray is hypertonic. The osmolarity of ZOMIG Nasal Spray for 2.5 mg is 360 to 420 mOsmol, and for 5 mg is 420 to 470 mOsmol. Chemical Structure

ZOMIG ® (zolmitriptan) tablets contain zolmitriptan, which is a selective 5‑hydroxytryptamine 1B/1D (5-HT 1B/1D ) receptor agonist. Zolmitriptan is chemically designated as (S)-4-[[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]methyl]-2-oxazolidinone and has the following chemical structure: The empirical formula is C­ 16 ­H­ 21 ­N­ 3 ­O­­ 2 ­, representing a molecular weight of 287.36. Zolmitriptan is a white to almost white powder that is readily soluble in water. ZOMIG tablets are available as 2.5 mg (yellow) and 5 mg (pink) film-coated tablets for oral administration. The film-coated tablets contain anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, colloidal silicon dioxide, titanium dioxide, polyvinyl alcohol, polyethylene glycol, talc, yellow iron oxide (2.5 mg tablet), and red iron oxide (5 mg tablet). structural figure