novadoz pharmaceuticals llc - Medication Listings

Lofexidine tablets contain lofexidine, a central alpha-2 adrenergic agonist, as the hydrochloride salt. Lofexidine hydrochloride is chemically designated as 2-[1-(2,6-dichlorophenoxy)ethyl]-4,5 dihydro-1 H -imidazole monohydrochloride with a molecular formula of C 11 H 12 Cl 2 N 2 O•HCl. Its molecular weight is 295.6 g/mole and its structural formula is: Lofexidine hydrochloride is a white to off-white crystalline powder freely soluble in methanol, soluble in ethanol, in water, slightly soluble in chloroform and insoluble in n-Hexane. Lofexidine tablets are available as peach-colored, round shaped biconvex film-coated tablets for oral administration. Each tablet contains 0.18 lofexidine, equivalent to 0.2 mg of lofexidine hydrochloride, and the following inactive ingredients: 1.4 mg calcium stearate, 12.3 mg citric acid anhydrous, 92.6 mg lactose anhydrous, 5.7 mg microcrystalline cellulose, 1.1 mg povidone, 0.7 mg sodium lauryl sulphate, and Opadry OY S 9480 (contains hydroxypropyl cellulose, titanium dioxide, propylene glycol, indigo carmine and sunset yellow). lofexi-tab-structure

Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3a R ,4 S ,7 R ,7a S )-2-{(1 R ,2 R )-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2 H -isoindole-1,3-dione hydrochloride. Its molecular formula is C 28 H 36 N 4 O 2 S•HCl and its molecular weight is 529.14. The chemical structure is: Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. The 20 mg, 40 mg, 60 mg, 80 mg and 120 mg tablets contain the following inactive ingredients: carnauba wax, citric acid anhydrous, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, mannitol, polyethylene glycol, povidone, pregelatinized starch, and titanium dioxide. lurasidone-structure

Moxifloxacin hydrochloride, USP is a synthetic antibacterial agent for oral administration. Moxifloxacin, a fluoroquinolone, is available as the monohydrochloride salt of 1-cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. It is a slightly yellow to yellow powder or crystals, slightly hygroscopic substance with a molecular weight of 437.9. Its molecular formula is C 21 H 24 FN 3 O 4 *HCl and its chemical structure is as follows: 11.1 Moxifloxacin Tablets, USP Moxifloxacin tablets, USP are available as film-coated tablets containing moxifloxacin hydrochloride USP (equivalent to 400 mg moxifloxacin). The inactive ingredients are Lactose Monohydrate, Povidone, Lactose Anhydrous, Croscarmellose sodium, Colloidal silicon dioxide, Magnesium stearate, hypromellose, Titanium dioxide, Polyethylene glycol and Iron oxide red. structure

The chemical name for the active ingredient in nebivolol tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)­bis(6-fluorochroman-2-yl)]-2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]­nebivolol, respectively. Nebivolol’s molecular formula is (C 22 H 25 F 2 NO 4 •HCl) with the following structural formula: SRRR- or d-nebivolol hydrochloride RSSS- or l-nebivolol hydrochloride The molecular weight is 441.90 g/mol. Nebivolol hydrochloride is a white to off-white crystalline powder that is sparingly soluble in dimethyl formamide and slightly soluble in methanol. Nebivolol as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, nebivolol tablets contains the following inactive ingredients: Croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, pregelatinized starch, polysorbate 80, FD&C blue No. 2 (2.5 mg and 20 mg), FD&C yellow No. 6 (5 mg), and FD&C red No. 40 (10 mg). nebivolol-structure-1 nebivolol-structure-2

Nelarabine is a prodrug of the cytotoxic deoxyguanosine analogue, 9-β- D ­ arabinofuranosylguanine (ara-G). The chemical name for nelarabine is 2-amino-9-β- D -arabinofuranosyl-6-methoxy-9 H -purine. It has the molecular formula C 11 H 15 N 5 O 5 and a molecular weight of 297.27. Nelarabine has the following structural formula: Nelarabine is soluble in N, N dimethylformamide, slightly soluble in water and insoluble in cyclohexane. Nelarabine Injection is supplied as a clear, colorless, sterile, solution in glass single-dose vials. Each vial contains 250 mg of nelarabine (5 mg nelarabine per mL) and the inactive ingredient sodium chloride (4.5 mg per mL) in 50 mL Water for Injection, USP. Nelarabine is intended for intravenous infusion. Hydrochloric acid and sodium hydroxide may have been used to adjust the pH. The solution pH ranges from 5.0 to 7.0. nelarabine-structure

Nilotinib capsules contains nilotinib, which belongs to a pharmacologic class of drugs known as kinase inhibitors. Nilotinib drug substance, in the form of monohydrochloride sesquihydrate, is a white or slightly yellowish or slightly greenish-yellow powder with the molecular formula and weight, respectively, of C 28 H 23 ClF 3 N 7 O. 1.5 H 2 O and 593 g/mol (corresponding molecular formula and weight of nilotinib base, anhydrous are C 28 H 22 F 3 N 7 O and 529 g/mol, respectively). The solubility of nilotinib practically insoluble in water and heptane, slightly soluble in anhydrous ethanol. Nilotinib is not optically active. The pKa1 was determined to be 2.6 pKa2 was estimated to be 4.2. The chemical name of nilotinib monohydrochloride sesquihydrate is 4-methyl-N-(3-(4-methyl-1H-imidazol-l-yl)-5-(trifluoromethyl)phenyl)-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamide hydrochloride sesquihydrate. Its structure is shown below: Nilotinib capsules, for oral use, contain 50 mg, 150 mg, or 200 mg nilotinib base, anhydrous (equivalent to 56 mg, 168 mg, and 224 mg nilotinib monohydrochloride sesquihydrate respectively) with the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and poloxamer 188. The capsules contain gelatin, iron oxide (red), iron oxide (yellow) and titanium dioxide. The imprinting ink contains black iron oxide, propylene glycol, potassium hydroxide and shellac. nilotinib-cap-structure

Norepinephrine (sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine) is a sympathomimetic amine which differs from epinephrine by the absence of a methyl group on the nitrogen atom. Norepinephrine Bitartrate, USP is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt), monohydrate (molecular weight 337.28 g/mol) and has the following structural formula: Norepinephrine Bitartrate Injection, USP is supplied in a sterile aqueous solution in the form of the bitartrate salt to be administered by intravenous infusion. Norepinephrine is sparingly soluble in water, very slightly soluble in alcohol and ether, and readily soluble in acids. Each mL contains 1 mg of norepinephrine base (equivalent to 1.89 mg of norepinephrine bitartrate, anhydrous basis), sodium chloride for isotonicity, not more than 0.2 mg of sodium metabisulfite as an antioxidant. It has a pH of 3 to 4.5. The air in the containers has been displaced by nitrogen gas. nore-bitrate-inj-structure

Olmesartan medoxomil tablets USP, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil tablets, USP is described chemically as 1H-imidazole-5-carboxylic acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(1H-tetrazol-5-yl) [1, 1’-biphenyl]-4-yl] methyl]-, (5-methyl-2-oxo-1, 3-dioxol-4-yl) methyl ester. Its molecular formula is C 29 H 30 N 6 O 6 and its structural formula is: Olmesartan medoxomil USP, is a white to off-white, crystalline powder with a molecular weight of 558.59. It is sparingly soluble in methanol and practically insoluble in water. Olmesartan medoxomil USP is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, and (5 mg only) yellow iron oxide. Meets USP Dissolution Test 7. olmesartan-structure

Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of an angiotensin II receptor antagonist (AT1 subtype), olmesartan medoxomil, USP, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil, USP is 1H-imidazole-5-carboxylic acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(1H-tetrazol-5-yl) [1, 1’-biphenyl]-4-yl] methyl]-, (5-methyl-2-oxo-1, 3-dioxol-4-yl) methyl ester [USP]. Its molecular formula is C 29 H 30 N 6 O 6 and its structural formula is: Olmesartan medoxomil, USP is a white to off-white crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2 H -1,2,4-benzo-thiadiazine-7-sulfonamide 1,1­ dioxide. Its molecular formula is C 7 H 8 ClN 3 O 4 S 2 and its structural formula is: Hydrochlorothiazide, USP is a white or practically white, practically odourless, crystalline powder. Its molecular weight is 297.74. It is very slightly soluble in water, freely soluble in sodium hydroxide solution, in n–butylamine and in dimethyl formamide, sparingly soluble in methanol, insoluble in ether, in chloroform and in dilute mineral acids. Olmesartan medoxomil and hydrochlorothiazide tablet is available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil combined with 12.5 mg of hydrochlorothiazide, or 40 mg of olmesartan medoxomil combined with 25 mg of hydrochlorothiazide. Inactive ingredients include: hydroxypropylcellulose, lactose monohydrate, low-substituted hydroxypropylcellulose, microcrystalline cellulose, stearic acid, red iron oxide, talc, titanium dioxide, hypromellose and yellow iron oxide. olme-hcl-olme-structure olme-hcl-hydro-structure

Oseltamivir phosphate, USP an influenza neuraminidase inhibitor (NAI), is available as: Capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate In addition to the active ingredient, each capsule contains croscarmellose sodium, povidone K30, pregelatinized starch, sodium stearyl fumarate and talc. The 30 mg capsule shell contains gelatin, iron oxide red, iron oxide yellow, and titanium dioxide. The 45 mg capsule shell contains gelatin, iron oxide black, and titanium dioxide. The 75 mg capsule shell contains gelatin, iron oxide black, iron oxide red, iron oxide yellow, and titanium dioxide, each capsule is printed with black ink, which includes shellac, iron oxide black, propylene glycol and potassium hydroxide. Oseltamivir phosphate, USP is a white to off white powder with the chemical name (3R,4R,5S)-4-acetylamino-5-amino-3(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid, ethyl ester, phosphate (1:1). The chemical formula is C 16 H 31 N 2 O 8 P (free base). The molecular weight is 312.4 for oseltamivir free base and 410.40 for oseltamivir phosphate salt. The structural formula is as follows: osletamivir-structure

Oseltamivir phosphate, USP an influenza neuraminidase inhibitor (NAI), is available as: A powder for oral suspension, which when constituted with water as directed contains 6 mg per mL oseltamivir base. In addition to the active ingredient, the powder for oral suspension contains monosodium citrate, saccharin sodium, sodium benzoate, sorbitol, titanium dioxide, tutti‐frutti flavor nat & art, and xanthan gum. Oseltamivir phosphate, USP is a white to off white powder with the chemical name [3R-(3α,4β,5α)]–Ethyl 4-(acetylamino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate phosphate (1:1). The molecular formula is C 16 H 31 N 2 O 8 P. The molecular weight is 312.4 for oseltamivir free base and 410.40 for oseltamivir phosphate salt. The structural formula is as follows: str

Paclitaxel Injection, USP is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel Injection, USP is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, USP, 527 mg of purified polyoxyl 35 castor oil and 49.7% (v/v) dehydrated alcohol, USP and 2 mg citric acid, USP. Paclitaxel is a natural product with antitumor activity. Paclitaxel is obtained via an extraction process from Taxus X media. The chemical name for paclitaxel is (2aR, 4S,4aS,6R, 9S ,11S ,12S ,12aR, 12bS )-1,2a,3,4, 4a,6,9,10, 11,12,12a,12b- Dodecahydro-4,6,9 ,11, 12, 12b-hexahydroxy-4a,8,13,13-tetramethyl-7,11-methano-5H-cyclodeca[3,4]-benz[1,2-b]oxet-5-one6,12b-diacetate,12-benzoate,9-esterwith(2R,3S)-N-benzoyl-3-phenylisoserine Paclitaxel has the following structural formula: Paclitaxel, USP is a white to off-white powder with the molecular formula C 47 H 51 NO 14 and a molecular weight of 853.91. It is highly lipophilic, insoluble in water, soluble in alcohol, and melts at around 213 o to 222 o C. structure

Perampanel oral suspension contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(2-Oxo-1-phenyl-5-pyridin-2-yl-1,2-dihydropyridin-3- yl) benzonitrile hydrate (4:3). The molecular formula is C 23 H 15 N 3 O. ¾ H 2 O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is freely soluble in N-methyl pyrrolidone, sparingly soluble in acetonitrile, slightly soluble in methanol and practically insoluble in water. The chemical structure is: Oral Suspension Perampanel oral suspension is a white to off-white opaque liquid providing perampanel in a concentration of 0.5 mg/mL. The oral suspension contains the following inactive ingredients: citric acid anhydrous, microcrystalline cellulose and carboxy methyl cellulose sodium, poloxamer, purified water, simethicone emulsion, sodium benzoate, and sorbitol solution. peram-oral-sus-structure

Perampanel tablets contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(2-Oxo-1-phenyl-5-pyridin-2-yl-1,2-dihydropyridin-3 yl)benzonitrile hydrate (4:3). The molecular formula is C 23 H 15 N 3 O • ¾ H 2 O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is freely soluble in N-Methyl pyrrolidone, sparingly soluble in acetonitrile, slightly soluble in methanol and practically insoluble in water. The chemical structure is: Tablets Perampanel tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, povidone. The 2 mg film-coated tablets contain hypromellose, polyethylene glycol, titanium dioxide, iron oxide red and iron oxide yellow, 4 mg contains hypromellose, polyethylene glycol, titanium dioxide, talc and iron oxide red, 6 mg contains hypromellose, polyethylene glycol, titanium dioxide and iron oxide red, 8 mg contains hypromellose, polyethylene glycol, talc, titanium dioxide, iron oxide red and black iron oxide, 10 mg contains hypromellose, polyethylene glycol, titanium dioxide, iron oxide yellow and FD&C BLUE #2, 12 mg contains hypromellose, polyethylene glycol, titanium dioxide, iron oxide yellow and FD&C BLUE #2. peram-tabs-structure

Phenylephrine Hydrochloride Injection contains active pharmaceutical ingredient phenylephrine in the form of hydrochloride salt. Phenylephrine is a synthetic sympathomimetic agent in sterile form for parenteral injection. Phenylephrine hydrochloride chemical name is (-)- m -Hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride and has the following structural formula: Phenylephrine hydrochloride is freely soluble in water and alcohol. Phenylephrine hydrochloride is sensitive to light. Phenylephrine Hydrochloride Injection, USP, 10 mg/mL: Phenylephrine Hydrochloride injection, USP is a clear, colorless, aqueous solution that is essentially free of visible foreign matter. It MUST BE DILUTED before administration as bolus intravenous infusion or continuous intravenous infusion. Each mL contains: 10 mg of Phenylephrine Hydrochloride (equivalent to 8.2 mg of phenylephrine base); 3.5 mg of Sodium Chloride USP as tonicity agent; 1 mg of Citric Acid Monohydrate USP and 4 mg of Sodium Citrate Dihydrate USP, as buffering agents; 2 mg of Sodium Metabisulfite USP, as antioxidant, and Sodium Hydroxide NF and Hydrochloric Acid NF, as pH adjusters in Water for Injection. Phenylephrine Hydrochloride injection pH range is 3.0 to 6.5. phenyl-inj-structure

Pimavanserin capsule contains pimavanserin, an atypical antipsychotic, which is present as pimavanserin tartrate salt with the chemical name, urea, N-[(4-fluorophenyl)methyl]-N-(1-methyl-4-piperidinyl)-N’-[[4-(2-methylpropoxy)phenyl]methyl]-,(2R,3R)-2,3-dihydroxybutanedioate (2:1). Pimavanserin tartrate is freely soluble in water, soluble in dichloromethane and practically insoluble in cyclohexane. Its molecular formula is (C 25 H 34 FN 3 O 2 ) 2 .C 4 H 6 O 6 and its molecular weight is 1005.20 (tartrate salt). The chemical structure is: The molecular formula of pimavanserin free base is C 25 H 34 FN 3 O 2 and its molecular weight is 427.55. Pimavanserin capsules are intended for oral administration only. Each capsule contains 40 mg of pimavanserin tartrate, which is equivalent to 34 mg of pimavanserin free base. Inactive ingredients include polyethylene glycol. Additionally, the following inactive ingredients are present as components of the capsule shell: FD&C blue #1, hypromellose, titanium dioxide, and yellow iron oxide. The printing ink contains shellac, propylene glycol, black iron oxide. pimavanserin-structure

Pirfenidone belongs to the chemical class of pyridone. Pirfenidone is available as film-coated tablets containing 267 mg and 801 mg pirfenidone. Pirfenidone has a molecular formula of C 12 H 11 NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1­ phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white to pale yellow, non-hygroscopic powder. It is freely soluble in dichloromethane, methanol, soluble in ethanol and practically insoluble in water. The melting point is approximately 109°C. Pirfenidone tablets contain pirfenidone and the following inactive ingredients: croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, titanium dioxide, macrogol (polyethylene glycol) and talc. str

Plerixafor injection is a sterile, preservative-free, clear, colorless to pale-yellow, isotonic solution for subcutaneous injection. Each mL of the sterile solution contains 20 mg of plerixafor. Each single-dose vial is filled to deliver 1.2 mL of the sterile solution that contains 24 mg of plerixafor and 5.9 mg of sodium chloride in Water for Injection adjusted to a pH of 6.0 to 7.5 with hydrochloric acid and with sodium hydroxide, if required. Plerixafor is a hematopoietic stem cell mobilizer with a chemical name l, 1′-[1,4­-phenylenebis (methylene)]-bis-1,4,8,11-tetraazacyclo-tetradecane. It has the molecular formula C 28 H 54 N 8 . The molecular weight of plerixafor is 502.79 g/mol. The structural formula is provided in Figure 1. Figure 1: Structural Formula Plerixafor is a white to off-white crystalline solid. It is hygroscopic. Plerixafor has a typical melting point of 131.5°C. The partition coefficient of plerixafor between 1-octanol and pH 7 aqueous buffer is <0.1. plerixafor-structure

Posaconazole is an azole antifungal agent. Posaconazole is available as delayed-release tablet intended for oral administration. Posaconazole is designated chemically as 4-[4-[4-[4-[[(3R,5R)-5-(2,4-difluorophenyl)tetrahydro-5-­(1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2­-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with a molecular formula of C 37 H 42 F 2 N 8 O 4 and a molecular weight of 700.8. The chemical structure is: Posaconazole is a white to off-white color powder with a low aqueous solubility. Posaconazole delayed-release tablet is a yellow colored, capsule shaped, textured, biconvex film-coated tablets debossed with 'MP 1' on one side and plain on other side containing 100 mg of posaconazole. Each delayed-release tablet contains the inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropylcellulose, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, iron oxide yellow, polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide. pos-dr-tab-structure

Prazosin hydrochloride, USP a quinazoline derivative, is the first of a new chemical class of antihypertensives. The chemical name of prazosin hydrochloride, USP is 1-(4-amino-6,7-dimethoxy­2-quinazolinyl)-4-(2-furoyl) piperazine monohydrochloride and its structural formula is: Molecular formula C 19 H 21 N 5 O 4 • HCl It is a white to tan powder, slightly soluble in methanol, dimethylformamide, dimethyl acetamide, very slightly soluble in alcohol, practically insoluble in chloroform and in acetone and has a molecular weight of 419.86. Each 1 mg capsule of prazosin hydrochloride, USP for oral use contains drug equivalent to 1 mg free base. Each 2 mg capsule of prazosin hydrochloride, USP for oral use contains drug equivalent to 2 mg free base. Each 5 mg capsule of prazosin hydrochloride, USP for oral use contains drug equivalent to 5 mg free base. Prazosin hydrochloride capsules, USP contains the following inactive ingredients colloidal silicon dioxide, lactose monohydrate, maize starch, magnesium stearate, sodium lauryl sulfate and sodium starch glycolate. The empty gelatin capsule shells contain titanium dioxide and gelatin. In addition, the 2 mg and 5 mg empty gelatin capsule shells contain FD&C Red No. 3, and FD&C Blue No. 1. The imprinting ink contains black iron oxide, propylene glycol, potassium hydroxide and shellac. FDA approved dissolution test specification differs from the USP. prazosin-cap-structure

Pregabalin is described chemically as ( S )-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8 H 17 NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is: Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. 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 – 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with mannitol and talc as inactive ingredients. The capsule shells contain FD&C Blue No. 2, gelatin, titanium dioxide, sodium lauryl sulfate and is imprinted with black ink. Black imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide. str

Pregabalin extended-release tablets are for oral use and contain pregabalin. Pregabalin USP is described chemically as ( S )-3-(Aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8 H 17 NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin USP is: Pregabalin USP is a white to off-white, crystalline solid with a pKa of 4.2 – 10.6. It is sparingly soluble in water and feely soluble in both basic and acidic aqueous solution. Pregabalin extended-release tablets are administered orally and contain 82.5 mg, 165 mg, or 330 mg of pregabalin, along with carbopol, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, silicon dioxide. Film Coating contains polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide red (for 82.5 mg, 165 mg and 330 mg tablets), black iron oxide, (82.5 mg tablets) iron oxide yellow (for 330 mg tablets) and colorants as inactive ingredients. str

Prucalopride tablets for oral use contain prucalopride succinate, a dihydrobenzofurancarboxamide that is a serotonin type 4 (5-HT 4 ) receptor agonist. The IUPAC name is: 4­-amino-5-chloro-N-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydrobenzofuran-7-carboxamide succinate. The molecular formula is C 18 H 26 ClN 3 O 3 .C 4 H 6 O 4 and the molecular weight is 485.96. The structural formula is: Prucalopride succinate is a white to almost white powder. It is freely soluble in water, soluble in dimethyl sulfoxide and insoluble in acetonitrile. Each 1-mg of prucalopride film-coated tablet contains 1 mg of prucalopride (equivalent to 1.32 mg prucalopride succinate), and the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The coating for the 1-mg tablet contains hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide and triacetin. Each 2-mg of prucalopride film-coated tablet contains 2 mg of prucalopride (equivalent to 2.64 mg prucalopride succinate), and the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The coating for the 2-mg tablet contains hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide, triacetin, red iron oxide, yellow iron oxide and FD&C Blue #2. prucalopride-tabs-structure

Pyridostigmine bromide oral solution, USP is an orally active cholinesterase inhibitor. Chemically, pyridostigmine bromide, USP is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural formula is: The molecular formula of pyridostigmine bromide, USP is C 9 H 13 BrN 2 O 2 having a molecular weight of 261.12. Pyridostigmine bromide oral solution, USP contains 60 mg pyridostigmine bromide per teaspoonful in a vehicle containing 0.23% w/w alcohol, glycerin, lactic acid, sodium benzoate, sorbitol, sucrose, raspberry-flavor (propylene glycol, Nat & Art flavor) and water. pyridostigmine-structure

The active ingredient in Roflumilast Tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5- dichloropyridin-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxy-benzamide. Its molecular formula is C 17 H 14 Cl 2 F 2 N 2 O 3 and the molecular weight is 403.22. The chemical structure is: The drug substance is a white to off-white non-hygroscopic powder with a melting point of 160°C. It is practically insoluble in water and hexane, sparingly soluble in ethanol and methanol, and soluble in N,N-Dimethyl formamide. Roflumilast Tablets are supplied as white to off-white, round, flat face bevel edged, uncoated tablets, debossed with “R” on one side and “0.25” or “0.5” on the other side. Each tablet contains 250 mcg or 500 mcg of roflumilast. Each tablet of Roflumilast Tablets for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, polysorbate 80 and pregelatinised starch. roflumilast-structure

Rufinamide, USP is a triazole derivative structurally unrelated to currently marketed antiepileptic drugs (AEDs). Rufinamide, USP has the chemical name 1-[(2,6-difluorophenyl)methyl]-1H-1,2,3-triazole-4 carboxamide. It has an molecular formula of C 10 H 8 F 2 N 4 O and a molecular weight of 238.2. The drug substance is a white, crystalline, odorless, and slightly bitter tasting neutral powder. Rufinamide, USP is practically insoluble in water, slightly soluble in tetrahydrofuran and in methanol and soluble in dimethyl sulfoxide. Rufinamide is available for oral administration as a liquid containing rufinamide, USP at a concentration of 40 mg/mL. Inactive ingredients include anhydrous citric acid, colloidal silicon dioxide, microcrystalline cellulose and carboxymethylcellulose sodium, poloxamer 188, methylparaben, non-crystallizing sorbitol solution 70%, propylparaben, propylene glycol, potassium sorbate, orange flavor, triacetin, natural and artificial flavor, simethicone emulsion 30%, and xanthan gum. rufi-suspn-structure

Sacubitril and valsartan tablet is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contains anionic forms of sacubitril and valsartan, and sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, the drug substance dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The drug substance is chemically described as Tri sodium (4-{[(1S, 3R)-1-([1,1 '-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutonoate-(N-pentanoyl-N-{[2'-(1H-tetrazol-1-id-5-yl)[1,1’-biphenyl]-4-yl]methyl}-L-valinate). Its molecular formula is C 48 H 55 N 6 O 8 Na 3 Its molecular mass is 912.96 g/mol and its schematic structural formula is: Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are colloidal silicon dioxide, crospovidone, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and talc. The film-coat inactive ingredients are hypromellose, titanium dioxide, macrogol, talc and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet also contains iron oxide yellow. structure

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 ® for erectile dysfunction. Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula: Sildenafil citrate is a white or almost white, slightly hygroscopic crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil for Oral Suspension: Sildenafil for oral suspension is supplied as white to off-white powders containing 1.57 g of sildenafil citrate (equivalent to 1.12 g sildenafil) in an amber glass bottle intended for reconstitution. Following reconstitution with 90 mL water, the 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 anhydrous, grape flavor, sorbitol, sodium citrate dihydrate, sucralose, titanium dioxide, sodium benzoate 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. sild-susp-structure

Silodosin capsules is the brand name for silodosin, a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3- Hydroxypropyl)-5-[(2R)-2-({2-[2-(2,2,2-trifluoroethoxy) phenoxy]ethyl} amino) propyl]-2,3-dihydro-1H-indole-7-carboxamide and the molecular formula is C 25 H 32 F 3 N 3 O 4 with a molecular weight of 495.53. The structural formula of silodosin is: Silodosin is a white to pale yellowish white powder that melts at approximately 104.72 to 107.5 °C. It is freely soluble in acetic acid, and in absolute alcohol, and insoluble in water. Each Silodosin 8 mg capsule for oral administration contains 8 mg silodosin, and the following inactive ingredients: magnesium stearate, magnesium aluminometasilicate, mannitol, polysorbate 80 and pregelatinized starch. The size #1 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing shellac, propylene glycol, black iron oxide and potassium hydroxide. Each Silodosin 4 mg capsule for oral administration contains 4 mg silodosin, and the following inactive ingredients: magnesium stearate, magnesium aluminometasilicate, mannitol, polysorbate 80 and pregelatinized starch. The size #3 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible ink containing shellac, propylene glycol, black iron oxide and potassium hydroxide. structure

Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus . The chemical name of sirolimus (also known as rapamycin) is (3 S ,6 R ,7 E ,9 R ,10 R ,12 R ,14 S ,15 E ,17 E ,19 E ,21 S ,23 S ,26 R ,27 R ,34a S )­-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-hexadecahydro-9,27-dihydroxy-3-[(1 R )-2-[(1 S ,3 R ,4 R )-4­hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy­3 H -pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4 H ,6 H ,31 H )-pentone. Its molecular formula is C 51 H 79 NO 13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder Freely soluble in Chloroform, acetone, methanol, methylene dichloride and acetonitrile. Soluble in ethanol and ethyl acetate. Insoluble in water. Sirolimus is available for administration as an oral solution containing 1 mg/mL sirolimus. The inactive ingredients in sirolimus oral solution are Phosal 50 PG ® (phosphatidylcholine, propylene glycol, sunflower seed oil glyceride, ethanol, soy fatty acids, ascorbyl palmitate and tocopherol) and polysorbate 80. Sirolimus oral solution contains 1.5% - 2.5% ethanol. sirolimus-structure

Solifenacin succinate tablets (solifenacin succinate) is a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with (1 S )-(3 R )-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1 H )-iso-quinolinecarboxylate(1:1) having an molecular formula of C 23 H 26 N 2 O 2 • C 4 H 6 O 4 and a molecular weight of 480.55. The structural formula of solifenacin succinate is: Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is soluble in water and in methanol. Each solifenacin succinate tablet contains 5 or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, talc, titanium dioxide and triacetin with yellow ferric oxide (5 mg solifenacin succinate tablet) or red ferric oxide (10 mg solifenacin succinate tablet). strucutre

Sunitinib is a kinase inhibitor present in sunitinib malate capsules as the malate salt. Sunitinib malate is described chemically as (2S)-2-hydroxybutanedoic acid with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1). The molecular formula is C 22 H 27 FN 4 O 2 • C 4 H 6 O 5 and the molecular weight is 532.6 Daltons. The chemical structure of sunitinib malate is: Sunitinib malate is a yellow to orange powder with a pKa of 8.56.The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 25 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. Sunitinib malate capsules, for oral use, are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively). The capsules contain the following inactive ingredients: croscarmellose sodium, mannitol, magnesium stearate and pregelatinized starch as inactive ingredients. In addition 12.5 mg capsule shell contains gelatin, titanium dioxide and red iron oxide. The white printing ink contains shellac, propylene glycol, potassium hydroxide and titanium dioxide. In addition 25 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, black iron oxide and red iron oxide. The white printing ink contains shellac, propylene glycol, potassium hydroxide and titanium dioxide. In addition 37.5 mg capsule shell contains gelatin, titanium dioxide and yellow iron oxide. The black printing ink contains shellac, propylene glycol, potassium hydroxide and black iron oxide. In addition 50 mg capsule shell contains gelatin, titanium dioxide, yellow iron oxide, red iron oxide and black iron oxide. The white printing ink contains shellac, propylene glycol, potassium hydroxide and titanium dioxide. sunitinib-structure

Thiotepa is an alkylating agent. Thiotepa for injection, USP is supplied as a non-pyrogenic, sterile lyophilized white powder for intravenous, intracavitary, or intravesical use after reconstitution and dilution. Thiotepa for injection, USP is available in a single-dose vial containing: 15 mg thiotepa. After reconstitution with 1.5 ml of water for injection, each ml contains 10 mg thiotepa. 100 mg thiotepa. After reconstitution with 10 ml of water for injection, each ml contains 10 mg thiotepa. 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 189.22, and it appears as fine, white crystalline flakes, with a melting range of 52°C to 57°C. It is soluble in alcohol, in chloroform and in ether; soluble in water and methanol. 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. strctre

Tiagabine hydrochloride USP is an antiepilepsy drug available as 2 mg, 4 mg, 12 mg, and 16 mg tablets for oral administration. Its chemical name is (-)-(R)-1-[4,4-Bis(3-methyl-2-thienyl)-3­ butenyl]nipecotic acid hydrochloride, its molecular formula is C 20 H 25 NO 2 S 2 HCl, and its molecular weight is 412.01. Tiagabine HCl, USP is a white to off-white powder. It is freely soluble in methanol and in alcohol, soluble in 5% Water in isopropanol, very slightly soluble in chloroform, sparingly soluble in water and practically insoluble in n-Heptane. The structural formula is: Inactive Ingredients Tiagabine hydrochloride tablets contain the following inactive ingredients: Butylated hydroxyanisole, colloidal silicon dioxide, crospovidone, hydrogenated vegetable oil (cottonseed oil), hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, stearic acid and titanium dioxide. In addition, individual tablets contain: 2 mg tablets: FD&C yellow No. 6 aluminum lake 4 mg tablets: D&C yellow No. 10 aluminum lake 12 mg tablets: D&C yellow No. 10 aluminum lake and FD&C Blue No. 1 aluminum lake 16 mg tablets: FD&C blue No. 2 aluminum lake tia-str

Ticagrelor tablets contain ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP-receptor. Chemically it is (1S,2S,3R,5S)-3-[7-{[(1R,2S)-2-(3,4-­difluorophenyl)cyclopropyl]amino}-5-(propylthio)-3H-[1,2,3]-triazolo[4,5-d]pyrimidin-3-yl]-5-(2-­hydroxyethoxy)cyclopentane-1,2-diol. The molecular formula of ticagrelor is C 23 H 28 F 2 N 6 O 4 S and its molecular weight is 522.57. The chemical structure of ticagrelor is: Ticagrelor is a crystalline powder with an aqueous solubility of approximately 10 mcg/mL at room temperature. Ticagrelor 90 mg tablets for oral administration contain 90 mg of ticagrelor and the following ingredients: croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl cellulose, magnesium stearate and mannitol. The tablets are film-coated with a coating material containing hydroxypropyl methylcellulose, iron oxide red, iron oxide yellow, polyethylene glycol 400, talc and titanium dioxide. Ticagrelor 60 mg tablets for oral administration contain 60 mg of ticagrelor and the following ingredients: croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl cellulose, magnesium stearate and mannitol. The tablets are film-coated with a coating material containing hydroxypropyl methylcellulose, iron oxide red, iron oxide yellow, polyethylene glycol 400, talc and titanium dioxide. tica-tabs-structure

Tolvaptan, is a selective vasopressin V2-receptor antagonist in tablets for oral use available in 15 mg or 30 mg strengths. Tolvaptan is (±)-4'-[(7-chloro-2,3,4,5-tetrahydro-5-hydroxy-1H-1-benzazepin-1-yl) carbonyl]-o-tolu- m -toluidide. The molecular formula is C 26 H 25 ClN 2 O 3 . Molecular weight is 448.94. The chemical structure is: Inactive ingredients include corn starch, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and FD&C Blue No. 2 Aluminum Lake as colorant. tolvaptan-structure

Toremifene citrate tablets for oral administration each contain 88.5 mg of toremifene citrate, which is equivalent to 60 mg toremifene. Toremifene citrate tablets are estrogen agonist/antagonist. The chemical name of toremifene is: 2-{p-[(Z)-4-chloro-1,2-­diphenyl-1-butenyl]phenoxy}-N,N-dimethylethylamine citrate(1:1).The structural formula is: and the molecular formula is C 26 H 28 ClNO . C 6 H 8 O 7 . The molecular weight of toremifene citrate is 598.10. The pK a is 7.76. Freely soluble in dimethyl sulphoxide, sparingly soluble in methanol and insoluble in water. Toremifene citrate tablets are available only as tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone K 30, and sodium starch glycolate. structure

Trientine hydrochloride is 1,2-Ethanediamine, N,N'-bis (2-aminoethyl)-,dihydrochloride. It is a white to pale yellow crystalline powder. It is freely soluble in water, soluble in methanol, slightly soluble in alcohol (96%), and insoluble in chloroform and in ether. The empirical formula is C 6 H 18 N 4 •2HCl with a molecular weight of 219.16. The structural formula is: NH 2 (CH 2 ) 2 NH(CH 2 ) 2 NH(CH 2 ) 2 NH 2 •2HCI Trientine hydrochloride is a chelating compound for removal of excess copper from the body. Trientine hydrochloride capsules USP 250 mg are available as 250 mg capsules for oral administration.Trientine hydrochloride capsules USP 250 mg contains gelatin, iron oxide black, iron oxide red, iron oxide yellow, potassium hydroxide, propylene glycol, shellac, stearic acid and titanium dioxide as inactive ingredients.

Valganciclovir for oral solution contains valganciclovir hydrochloride, USP, a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. Valganciclovir hydrochloride, USP is available as a powder for oral solution, which when constituted with water as directed contains 50 mg/mL valganciclovir free base. The inactive ingredients of valganciclovir for oral solution are fumaric acid, mannitol, povidone K-29/32, saccharin sodium, sodium benzoate, and tutti-frutti flavoring. Valganciclovir hydrochloride, USP is a white to off-white powder with a molecular formula of C 14 H 22 N 6 O 5 ·HCl and a molecular weight of 390.8. The chemical name for valganciclovir hydrochloride is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir hydrochloride is a polar hydrophilic compound with a solubility of 100 mg/mL in water at 25°C at a pH 7.0 and an n-octanol/water partition coefficient of -2.37 at pH 7.0. The pKa for valganciclovir hydrochloride is 7.2. The chemical structure of valganciclovir hydrochloride is: All doses in this insert are specified in terms of valganciclovir. valganciclovir-structural-formula

Vigabatrin, USP is an oral antiepileptic drug and is available as white to off-white granular powder for oral solution in packets of 500 mg. The chemical name of vigabatrin, USP a racemate consisting of two enantiomers, is (±) 4-amino-5-hexenoic acid. The molecular formula is C 6 H 11 NO 2 and the molecular weight is 129.16. It has the following structural formula: Vigabatrin, USP is a white or almost white powder which is freely soluble in water, slightly soluble in methanol, practically insoluble in methylene chloride. The pH of a 1% aqueous solution is about 6.99. The 1-octanol/water partition coefficient of vigabatrin is about -2.32 (log P =-1.96) at physiologic pH. Vigabatrin, USP melts with decomposition in a 3-degree range within the temperature interval of 171°C to 176°C. The dissociation constants (pKa) of vigabatrin are 4 and 9.7 at room temperature (25°C). Vigabatrin for oral solution, USP is available as a white to off-white granular powder. Each packet contains 500 mg of vigabatrin, USP. The inactive ingredient is povidone. vigabatrin-structure

Vilazodone hydrochloride tablets for oral administration contain polymorph Form IV vilazodone hydrochloride (HCl), a selective serotonin reuptake inhibitor and a 5HT1A receptor partial agonist. Vilazodone Hydrochloride is 2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1H-indol-3-yl)butyl]-1-piperazinyl]-, hydrochloride with a molecular formula of C 26 H 27 N 5 O 2 .HCl. Its molecular weight is 479.99 g/mol. The structural formula is: Vilazodone hydrochloride tablets are available as 10 mg, 20 mg, and 40 mg film-coated tablets containing 10 mg, 20 mg, and 40 mg of vilazodone HCl, respectively. In addition to the active ingredient, vilazodone hydrochloride tablets contain the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1 Aluminum Lake (40 mg only), Ferric Oxide Red (10 mg only) and FD&C Yellow #6 Aluminum Lake (20 mg only), lactose monohydrate, macrogol (polyethylene glycol), magnesium stearate, microcrystalline cellulose, opadry II blue (for 40 mg), opadry II pink (for 10 mg) and opadry II orange (for 20 mg), polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc. vilazodone-str

Ziprasidone mesylate for injection is an atypical antipsychotic available as an injection (ziprasidone mesylate) for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The molecular formula of C 21 H 21 ClN 4 O S (free base of ziprasidone) represents the following structural formula: Ziprasidone mesylate for injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2­ benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The molecular formula is C 21 H 21 ClN 4 OS • CH 3 SO 3 H • 3H 2 O and its molecular weight is 563.09. Ziprasidone mesylate for injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [see Dosage and Administration (2.4) ]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD). str