major pharmaceuticals - Medication Listings

Browse 408 medications manufactured by major pharmaceuticals. Open a product record to review dosage forms, strengths, packaging, and related navigation.

Nifedipine NIFEDIPINE
MAJOR PHARMACEUTICALS FDA Rx Only

Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, dimethyl ester, C 17 H 18 N 2 O 6 , and has the structural formula: Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine GITS (Gastrointestinal Therapeutic System) tablet is formulated as a once-a-day controlled-release tablet for oral administration designed to deliver 30, 60, or 90 mg of nifedipine. Inert ingredients in the formulations are: cellulose acetate; ferric oxide; hypromellose; magnesium stearate; polyethylene glycol; polyethylene oxide; potassium chloride; povidone; sodium chloride; titanium dioxide; propylene glycol and black iron oxide. The USP Dissolution Test is pending. System Components and Performance Nifedipine extended-release tablets are similar in appearance to a conventional tablet. It consists, however, of a semipermeable membrane surrounding an osmotically active drug core. The core itself is divided into two layers: an “active” layer containing the drug, and a “push” layer containing pharmacologically inert (but osmotically active) components. As water from the gastrointestinal tract enters the tablet, pressure increases in the osmotic layer and “pushes” against the drug layer, releasing drug through the precision laser-drilled tablet orifice in the active layer. Nifedipine extended-release tablets are designed to provide nifedipine at an approximately constant rate over 24 hours. This controlled rate of drug delivery into the gastrointestinal lumen is independent of pH or gastrointestinal motility. Nifedipine extended-release tablets depend for its action on the existence of an osmotic gradient between the contents of the bi-layer core and fluid in the gastrointestinal tract. Drug delivery is essentially constant as long as the osmotic gradient remains constant, and then gradually falls to zero. Upon swallowing, the biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the feces as an insoluble shell. structure

Night Time Cold and Flu Relief ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE
MAJOR PHARMACEUTICALS FDA OTC

Uses temporarily relieves common cold and flu symptoms: sore throat headache minor aches and pains fever runny nose and sneezing cough due to minor throat and bronchial irritation

nitrofurantoin macrocrystals NITROFURANTOIN MACROCRYSTALS
MAJOR PHARMACEUTICALS FDA Rx Only

Nitrofurantoin capsules, USP (macrocrystals) is a synthetic chemical of controlled crystal size. It is a stable, lemon-yellow, crystalline compound. Nitrofurantoin capsules, USP (macrocrystals) is an antibacterial agent for specific urinary tract infections. It is available in 50 mg and 100 mg capsules for oral administration. 1-[[(5-nitro-2-furanyl)methylene] amino]-2,4-imidazolidinedione Nitrofurantoin macrocrystals is a lemon-yellow crystalline compound. It is soluble in dimethylformamide, very slightly soluble in water and in alcohol. Each nitrofurantoin capsules, USP (macrocrystals) intended for oral administration contains 50 mg and 100 mg of nitrofurantoin macrocrystals. In addition, each capsule contains the following inactive ingredients: gelatin, lactose monohydrate, magnesium stearate, pregelatinized starch, talc and titanium dioxide. Additionally each 50 mg and 100 mg capsule shell contains FD & C Blue # 1, FD & C Red # 3 and sodium lauryl sulphate. The capsule is printed with black pharmaceutical ink which contains black iron oxide, potassium hydroxide, propylene glycol and shellac. figure

Nitrofurantoin Monohydrate/ Macrocrystalline NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINE

Nitrofurantoin is an antibacterial agent specific for urinary tract infections. Nitrofurantoin capsules, USP (monohydrate/macrocrystals) is a hard gelatin capsule. Each capsule contains 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate. The chemical name of nitrofurantoin macrocrystals is 1-[[[5-nitro-2-furanyl]methylene] amino]-2,4-imidazolidinedione. The chemical structure is the following: Molecular Weight: 238.16 The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-furanyl]methylene] amino]-2,4- imidazolidinedione monohydrate. The chemical structure is the following: Molecular Weight: 256.17 Inactive Ingredients: Each capsule contains carbomer 934P, corn starch, compressible sugar, D&C Yellow No. 10, edible gray ink, FD&C Blue No. 1, FD&C Red No. 40, gelatin, lactose, magnesium stearate, povidone, talc, and titanium dioxide. Meets USP Dissolution Test 8. structure-1 structure-2

Nystatin NYSTATIN
MAJOR PHARMACEUTICALS FDA Rx Only

Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei . Structural formula: Nystatin Oral Suspension USP, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), artificial peppermint flavor, cherry flavor, citric acid, D&C Yellow No. 10, FD&C Red No. 40, glycerin, magnesium aluminum silicate, methylparaben, potassium phosphate dibasic, propylene glycol, propylparaben, purified water and sucrose. Chemical Structure

ofloxacin OFLOXACIN
MAJOR PHARMACEUTICALS FDA Rx Only

Ofloxacin ophthalmic solution USP, 0.3% is a sterile ophthalmic solution. It is a fluorinated carboxyquinolone anti-infective for topical ophthalmic use. Chemical Name: (±)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7 H -pyrido[1,2,3- de ]-1,4-benzoxazine-6-carboxylic acid. Contains: Active: ofloxacin 0.3% (3 mg/mL). Preservative: benzalkonium chloride (0.005%). Inactives: sodium chloride and water for injection. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH. Ofloxacin ophthalmic solution, USP is unbuffered and formulated with a pH of 6.4 (range - 6.0 to 6.8). It has an osmolality of 300 mOsm/kg. Ofloxacin is a fluorinated 4-quinolone which differs from other fluorinated 4-quinolones in that there is a six member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure. Chemical Formula

Olanzapine OLANZAPINE
15 mg Tablet
MAJOR PHARMACEUTICALS FDA Rx Only

Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C 17 H 20 N 4 S, which corresponds to a molecular weight of 312.44. The chemical structure is: Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 15 mg (48 μmol) and 20 mg (64 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. srtucture

Olanzapine OLANZAPINE
2.5 mg Tablet
MAJOR PHARMACEUTICALS FDA Rx Only

Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C 17 H 20 N 4 S, which corresponds to a molecular weight of 312.44. The chemical structure is: Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 µmol), 5 mg (16 µmol), 7.5 mg (24 µmol) and 10 mg (32 µmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH 101) and microcrystalline cellulose (Avicel PH 102). The color coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. srtucture

OMEGA-3-ACID ETHYL ESTERS OMEGA 3 ACID ETHYL ESTERS CAPSULES
MAJOR PHARMACEUTICALS FDA Rx Only

Omega-3-acid ethyl esters, USP a lipid-regulating agent, are supplied as a liquid-filled gel capsule for oral administration. Each 1-gram capsule of omega-3-acid ethyl esters, USP contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA — approximately 465 mg) and docosahexaenoic acid (DHA — approximately 375 mg). The empirical formula of EPA ethyl ester is C 22 H 34 O 2 , and the molecular weight of EPA ethyl ester is 330.51. The structural formula of EPA ethyl ester is: The empirical formula of DHA ethyl ester is C 24 H 36 O 2 , and the molecular weight of DHA ethyl ester is 356.55. The structural formula of DHA ethyl ester is: Omega-3-acid ethyl esters capsules, USP also contain the following inactive ingredients: 4 mg a-tocopherol, gelatin, glycerol, and purified water (components of the capsule shell). EPA chemical structure DHA chemical structure

ondansetron ONDANSETRON HYDROCHLORIDE
MAJOR PHARMACEUTICALS FDA Rx Only

The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT 3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula: The molecular formula is C 18 H 19 N 3 O•HCl•2H 2 O, representing a molecular weight of 365.86 g/mol. Ondansetron HCl dihydrate is a white to off-white powder that is soluble in methanol, sparingly soluble in purified water and in alcohol, and slightly soluble in isopropyl alcohol, in dichloromethane, very slightly soluble in acetone, in chloroform and in ethyl acetate. Each 4 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 8 mg of ondansetron. Each 16 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 16 mg of ondansetron. Each 24 mg ondansetron tablets USP for oral administration contains ondansetron HCl dihydrate equivalent to 24 mg of ondansetron. Each tablet also contains the inactive ingredients colloidal silicon dioxide, hypromellose 2910(5cP) (for the 4 mg and 16 mg tablets only) and hypromellose 2910 (6cP) (for the 8 mg and 24 mg tablets only), iron oxide red and iron oxide black (for the 24 mg tablet only), iron oxide yellow (for the 8 mg and 24 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, and titanium dioxide. structure

OXCARBAZEPINE OXCARBAZEPINE
150 mg Tablet
MAJOR PHARMACEUTICALS FDA Rx Only

Oxcarbazepine is an antiepileptic drug available as 150 mg, 300 mg, and 600 mg film-coated tablets for oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5 H -dibenz[b, f ]azepine-5-carboxamide, and its structural formula is: Oxcarbazepine is a white to faintly orange crystalline powder. It is slightly soluble in chloroform, dichloromethane, acetone, and methanol and practically insoluble in ethanol, ether and water. Its molecular weight is 252.27 g/mol. Oxcarbazepine film-coated tablets contain the following inactive ingredients: microcrystalline cellulose, crospovidone, hypromellose, colloidal silicon dioxide, magnesium stearate, talc. Coating: polyvinyl alcohol, talc, titanium dioxide, polyethylene glycol, Contains FD&C Yellow No. 6 as a color additive. FD&C Yellow No. 6 aluminum lake, lecithin, FD&C Blue No. 2 aluminum lake, Contains FD&C Yellow No. 5 as a color additive. [See WARNINGS AND PRECAUTIONS (5.12) ]. FD&C Yellow No. 5 aluminum lake. Allergen Statement: This product contains soy. Oxcarbazepine Tablets, USP complies with USP Dissolution Test 2. Chemical Structure

OXYCODONE AND ACETAMINOPHEN OXYCODONE AND ACETAMINOPHEN
MAJOR PHARMACEUTICALS FDA Rx Only

Oxycodone and Acetaminophen Tablets, USP is available in tablets for oral administration. Each tablet for oral administration contains: Oxycodone hydrochloride USP 5 mg* (*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone) Acetaminophen USP................................................. 325 mg Oxycodone hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone) Acetaminophen USP.............................................……....... 325 mg Oxycodone hydrochloride, USP 10 mg* (*10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone) Acetaminophen USP...................................................…..... 325 mg Inactive Ingredients The tablets contain: Colloidal silicon dioxide, pregelatinized starch, crospovidone, croscarmellose sodium, microcrystalline cellulose, stearic acid and magnesium stearate. In addition, the 5 mg/325 mg strength contains FD&C Blue # 1 Aluminum Lake and the 7.5 mg/325 mg strength contains FD&C Red # 40 Aluminum Lake. Oxycodone and Acetaminophen Tablets, USP contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18 H 21 NO 4 HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula: Oxycodone and Acetaminophen Tablets, USP contain acetaminophen, 4'-hydroxyacetanilie, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8 H 9 NO 2 and the molecular weight is 151.17. It may be represented by the following structural formula: 01 02

Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE
5 mg/5 ml Liquid
MAJOR PHARMACEUTICALS FDA Rx Only

Oxycodone hydrochloride oral solution is an opioid agonist, available as solution in 5 mg/5mL (1 mg/mL) strength for oral administration. Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6one hydrochloride and has the following structural formula: C 18 H 21 NO 4 •HCl MW 351.82 Oxycodone hydrochloride, USP is a white to off-white fine crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Oxycodone hydrochloride oral solution USP, 5 mg per 5 mL contains equivalent of 4.5 mg of oxycodone free base per 5 mL and contains the following inactive ingredients: sorbitol solution, saccharin sodium, anhydrous citric acid, sodium citrate dihydrate, sodium benzoate, FD&C red #40, mixed berry flavor, and purified water. str

Oxycodone Hydrochloride OXYCODONE
MAJOR PHARMACEUTICALS FDA Rx Only

Oxycodone HCl tablets, USP contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride, USP. Oxycodone hydrochloride, USP is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride, USP dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride, USP is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula: Each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and stearic acid. The 10 mg tablet also contains D&C Red No. 27. The 15 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 20 mg tablet also contains the following inactive ingredients: FD&C Blue No. 2, FD&C Red No. 40 and FD&C Yellow No. 6. The 30 mg tablet also contains the following inactive ingredients: D&C Yellow No. 10 and FD&C Blue No. 2. The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.6 mg, 9 mg, 13.5 mg, 18 mg, and 27 mg, respectively, of oxycodone free base. formula

Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE
5 mg/5 ml Liquid
MAJOR PHARMACEUTICALS FDA Rx Only

Oxycodone hydrochloride oral solution is an opioid agonist, available as solution in 5 mg/5mL (1 mg/mL) strength for oral administration. Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6one hydrochloride and has the following structural formula: C 18 H 21 NO 4 •HCl MW 351.82 Oxycodone hydrochloride, USP is a white to off-white fine crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Oxycodone hydrochloride oral solution USP, 5 mg per 5 mL contains equivalent of 4.5 mg of oxycodone free base per 5 mL and contains the following inactive ingredients: sorbitol solution, saccharin sodium, anhydrous citric acid, sodium citrate dihydrate, sodium benzoate, FD&C red #40, mixed berry flavor, and purified water. oxycodone-struct

Paliperidone PALIPERIDONE
1.5 mg Extended-release
MAJOR PHARMACEUTICALS FDA Rx Only

Paliperidone extended-release tablet contains paliperidone USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone contains a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-‑benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-‑pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23 H 27 FN 4 O 3 and its molecular weight is 426.49. The structural formula is: Paliperidone is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (brown), 3 mg (white to off-white), 6 mg (yellow), and 9 mg (pink) strengths. Paliperidone extended-release tablets are formulated as a polymer matrix based once-a-day controlled release tablet for oral use. Inactive ingredients are polyethylene oxide, hypromellose, anhydrous lactose, magnesium stearate, ethyl cellulose, triethyl citrate, talc, titanium dioxide and polyethylene glycol. The 1.5 mg and 6 mg tablets also contain lactose monohydrate, iron oxide yellow and iron oxide red. The 9 mg tablets also contain lactose monohydrate and iron oxide red. Imprinting ink contains shellac glaze, iron oxide black, N-butyl alcohol, propylene glycol and ammonium hydroxide. Delivery System Components and Performance Paliperidone extended release tablets employ a film-coated hydrophilic hydrogel matrix to deliver paliperidone at a controlled rate over 24 hours. The system comprises of: a core consists of the drug, rate-controlling polymer (forming hydrogel) and other excipients with pH independent coat surrounding core, comprising of water soluble and insoluble polymer and a film coat over it. Upon ingestion outer film coat dissolves exposing the coated tablet to the gastric fluids. Once the water soluble polymer from coat gets dissolved, pores are formed which allow penetration of fluid inside the membrane leading to hydration of core-forming hydrogel. Drug release occurs via slow diffusion out of the gel layer and subsequent gel erosion. structure

PAROXETINE PAROXETINE HYDROCHLORIDE
MAJOR PHARMACEUTICALS FDA Rx Only

Paroxetine tablets, USP contains paroxetine hydrochloride USP, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans -4 R -(4'-fluorophenyl)-3 S -[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride anhydrous and has the empirical formula of C 19 H 20 FNO 3 ·HCl. The molecular weight is 365.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is: Paroxetine hydrochloride USP is an odorless, off-white powder, having a melting point range of 116°C to 120°C and a solubility of 5.4 mg/mL in water. Each film-coated tablet, for oral administration, contains paroxetine hydrochloride equivalent to paroxetine as follows: 10 mg; 20 mg; 30 mg; 40 mg. Inactive ingredients consist of anhydrous lactose, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, sodium starch glycolate and titanium dioxide. Paroxetine tablets comply with USP Related Impurities Test 1. structure

PENTOXIFYLLINE PENTOXIFYLLINE
MAJOR PHARMACEUTICALS FDA Rx Only

Pentoxifylline extended-release tablets, USP for oral administration contain 400 mg of the active drug and the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, and titanium dioxide in an extended-release formulation. Pentoxifylline is a tri-substituted xanthine derivative designated chemically as 3,7-Dihydro-3,7-dimethyl-1-(5-oxohexyl)-1H-purine-2,6-dione that, unlike theophylline, is a hemorrheologic agent, i.e., an agent that affects blood viscosity. Pentoxifylline is soluble in water and ethanol, and sparingly soluble in toluene. The molecular formula is C 13 H 18 N 4 O 3 and its molecular weight is 278.31. The chemical structure is: USP Dissolution Test 9 structure

Perphenazine PERPHENAZINE
MAJOR PHARMACEUTICALS FDA Rx Only

Perphenazine (4-[3-(2-chlorophenothiazin-10-yl)propyl]-1-piperazineethanol), a piperazinyl phenothiazine, having the chemical formula, C 21 H 26 CIN 3 OS. It is available as oral tablets containing 2 mg, 4 mg, 8 mg, and 16 mg of perphenazine. Inactive ingredients: black iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, talc, titanium dioxide, yellow iron oxide. Its structural formula is: This is the structual formula for Perphenazine.

Petroleum Skin Protectant WHITE PETROLATUM

Uses temporarily protects minor: cuts- scrapes- burns temporarily protects and helps relieve chapped or cracked skin and lips helps protects from the drying effects of wind and cold weather

Phenobarbital PHENOBARBITAL
MAJOR PHARMACEUTICALS FDA Rx Only

The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5-phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula: Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg or 97.2 mg of phenobarbital. In addition each tablet contains: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. This is the image of the structual formula for Phenobarbital.

Phenytoin PHENYTOIN
50 mg Tablet
MAJOR PHARMACEUTICALS FDA Rx Only

Phenytoin is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-diphenyl-2,4 imidazolidinedione, having the following structural formula: Each phenytoin chewable tablet, USP for oral administration, contains 50 mg phenytoin, USP. Also contains: Artificial banana flavor, compressible sugar, D&C yellow No. 10 aluminum lake, FD&C yellow No. 6 aluminum lake, hypromellose 2208, lactose monohydrate, magnesium stearate, saccharin sodium, and talc. Chemical Structure

Phenytoin Sodium PHENYTOIN SODIUM
100 mg Capsule
MAJOR PHARMACEUTICALS FDA Rx Only

Phenytoin is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-diphenyl-2,4 imidazolidinedione, having the following structural formula: Each extended phenytoin sodium capsule, USP for oral administration contains 100 mg phenytoin sodium, USP. Also contains confectioner's sugar, hypromellose, lactose monohydrate, magnesium stearate, and talc. The capsule shell contains benzyl alcohol, black ink, butylparaben, D&C Yellow #10, edetate calcium disodium, FD&C Red #3, gelatin, methylparaben, propylparaben, sodium lauryl sulfate, sodium propionate, and titanium dioxide. Product in vivo performance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours as contrasted to Prompt Phenytoin Sodium Capsules, USP with a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours. Meets USP Dissolution Test 2. Chemical Structure

Phytonadione PHYTONADIONE
5 mg Tablet
MAJOR PHARMACEUTICALS FDA Rx Only

Phytonadione is a vitamin K replacement, which is a clear, yellow to amber, very viscous, odorless or practically odourless liquid. It is soluble in dehydrated alcohol, benzene, chloroform and ether; slightly soluble in alcohol (96%) and insoluble in water. It has a molecular weight of 450.70 g/mol. Phytonadione is 1,4-Naphthalenedione, 2-methyl-3-(3,7,11,15-tetramethyl-2-hexadecenyl)-,[R-[R*,R*-(E)]]. Its molecular formula is C 31 H 46 O 2 and its structural formula is: Phytonadione tablets, USP for oral administration contain 5 mg of phytonadione, USP and are light yellow to yellow colored, round, scored tablets, debossed with “AA” and “05” on either side of scoring and plain on the other side. Inactive ingredients are acacia, anhydrous dibasic calcium phosphate, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, and talc. str

Pioglitazone PIOGLITAZONE
15 mg Tablet
MAJOR PHARMACEUTICALS FDA Rx Only

Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon, and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo . No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown: Pioglitazone hydrochloride USP is an off-white to pale yellow color powder that has a molecular formula of C 19 H 20 N 2 O 3 S•HCl and a molecular weight of 392.90 daltons. It is soluble in N,N - dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone is available as a tablet for oral administration containing 15 mg, 30 mg, or 45 mg of pioglitazone (as the base) formulated with the following excipients: carboxymethylcellulose calcium, hydroxypropyl cellulose, lactose monohydrate, and magnesium stearate. chemical structure

PIRFENIDONE PIRFENIDONE
267 mg Tablet
MAJOR PHARMACEUTICALS FDA Rx Only

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

Polyethylene glycol 3350 POLYETHYLENE GLYCOL 3350
MAJOR PHARMACEUTICALS FDA OTC

Use relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days

POSACONAZOLE POSACONAZOLE
100 mg Delayed-release
MAJOR PHARMACEUTICALS FDA Rx Only

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-[[ (3 R ,5 R )-5- (2,4-difluorophenyl)tetrahydro-5 - (1 H -1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1 S ,2 S )-1-ethyl-2 - hydroxypropyl]-2,4-dihydro-3 H -1,2,4-triazol-3-one with an empirical 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 powder with a low aqueous solubility. Posaconazole delayed-release tablets are yellow, coated, capsule-shaped tablets containing 100 mg of posaconazole. Each delayed-release tablet contains the inactive ingredients: partially neutralized methacrylic acid and ethyl acrylate copolymer, triethyl citrate, xylitol, hydroxypropyl cellulose, propyl gallate, cellulose, microcrystalline, silica, colloidal anhydrous, croscarmellose sodium, sodium stearyl fumarate and Opadry® II Yellow (consists of the following ingredients: polyvinyl alcohol partially hydrolyzed, macrogol, polyethylene glycol, titanium dioxide, talc, and iron oxide yellow). Posaconazole

POTASSIUM CHLORIDE POTASSIUM CHLORIDE
MAJOR PHARMACEUTICALS FDA Rx Only

Potassium Chloride is a white crystalline or colorless solid. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Oral Solution: 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow #6, glycerin, methylparaben, natural orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose.

Potassium Chloride POTASSIUM CHLORIDE
600 mg Extended-release
MAJOR PHARMACEUTICALS FDA Rx Only

Potassium chloride extended-release tablets USP are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet. Potassium chloride extended-release tablets USP are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, crystalline powder or colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and practically insoluble in ethanol. Inactive Ingredients: Colloidal silicon dioxide, hydrogenated vegetable oil, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. In addition, the 8 mEq tablets contain iron oxide red. FDA approved acceptance criteria for assay differs from USP test. Meets USP Dissolution Test 5.

Potassium Chloride POTASSIUM CHLORIDE
750 mg Extended-release
MAJOR PHARMACEUTICALS FDA Rx Only

Potassium chloride extended-release capsules USP, 10 mEq are an oral dosage form of microencapsulated potassium chloride containing 750 mg of potassium chloride, USP equivalent to 10 mEq of potassium. The chemical name of the active ingredient is potassium chloride and the structural formula is KCl. It has a molecular mass of 74.55. Potassium chloride, USP occurs as a white granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. The inactive ingredients are, ethylcellulose, FD&C Blue #1, FD&C Red # 40, gelatin, sodium lauryl sulfate, titanium oxide and triethyl citrate.

Potassium Chloride POTASSIUM CHLORIDE
MAJOR PHARMACEUTICALS FDA Rx Only

The Potassium Chloride Extended-Release Tablets USP, 20 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. The Potassium Chloride Extended-Release Tablets USP, 15 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,125 mg of microencapsulated potassium chloride, USP equivalent to 15 mEq of potassium in a tablet. The Potassium Chloride Extended-Release Tablets USP, 10 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium Chloride is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Its molecular weight is 74.55 g/mole. Potassium chloride, USP occurs as a white to off-white, crystalline, granular powder. It is freely soluble in water and insoluble in alcohol. Potassium Chloride is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of out-side agitation, potassium chloride tablets begin disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride. Inactive Ingredients: croscarmellose sodium, ethyl cellulose, microcrystalline cellulose and triethyl citrate. Meets USP Dissolution Test 7.

povidone iodine POVIDONE IODINE
MAJOR PHARMACEUTICALS FDA OTC

For use as an first aid antiseptic pre-operative skin preperation

Pramipexole Dihydrochloride PRAMIPEXOLE DIHYDROCHLORIDE
MAJOR PHARMACEUTICALS FDA Rx Only

Pramipexole dihydrochloride tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is ( S )-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C 10 H 17 N 3 S · 2HCl · H 2 O, and its molecular weight is 302.26. The structural formula is: Pramipexole dihydrochloride USP is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride USP is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets, for oral administration, contain 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, or 1.5 mg of pramipexole dihydrochloride monohydrate. Inactive ingredients consist of colloidal silicon dioxide, corn starch, ferric oxide red (0.25, 0.5 and 1 mg tablets), ferric oxide yellow (0.25 and 0.75 mg tablets), magnesium stearate, mannitol, povidone K-30 and pregelatinized maize starch. Pramipexole dihydrochloride tablets 0.125 mg : Each tablet contains 0.125 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.118 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.25 mg : Each tablet contains 0.25 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.235 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.5 mg : Each tablet contains 0.5 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.47 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 0.75 mg : Each tablet contains 0.75 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.705 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 1 mg : Each tablet contains 1 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 0.94 mg pramipexole dihydrochloride (in anhydrous basis). Pramipexole dihydrochloride tablets 1.5 mg : Each tablet contains 1.5 mg pramipexole dihydrochloride USP (in monohydrate form) equivalent to 1.41 mg pramipexole dihydrochloride (in anhydrous basis). 3

PRAVASTATIN SODIUM PRAVASTATIN SODIUM
MAJOR PHARMACEUTICALS FDA Rx Only

Pravastatin sodium is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium is designated chemically as Sodium (3R,5R)-3,5-dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-[[(2S)-methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoate. Structural Formula: Pravastatin sodium is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/ water) of 0.59 at a pH of 7. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin sodium tablets for oral use contains 10 mg, 20 mg, 40 mg and 80mg pravastatin sodium. Inactive ingredients include: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The 10 mg tablet also contains Red Ferric Oxide, the 20 mg tablet also contains Yellow Ferric Oxide, the 40 mg tablet also contains a blend of Yellow Ferric Oxide and FD&C Blue #1 Aluminum Lake, and the 80 mg tablet also contains Yellow Ferric Oxide. pravastatin-structure

Prazosin Hydrochloride PRAZOSIN HYDROCHLORIDE
MAJOR PHARMACEUTICALS FDA Rx Only

Prazosin hydrochloride, USP a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine 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 water, practically insoluble in chloroform and acetone and has a molecular weight of 419.87. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The empty hard gelatin capsules contain black iron oxide, gelatin, red iron oxide, titanium dioxide and yellow iron oxide. In addition, the 1 mg empty gelatin capsules contain D&C Yellow No. 10 and FD&C Green No. 3; the 2 mg empty gelatin capsules contain D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1 and FD&C Red No. 40; and the 5 mg empty gelatin capsules contain FD&C Blue No. 1. The capsules shells are imprinted in edible ink which contains concentrated ammonium solution, potassium hydroxide, propylene glycol, shellac and titanium dioxide. Prazosin Structure

PREGABALIN PREGABALIN
25 mg Capsule
MAJOR PHARMACEUTICALS FDA Rx Only

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 or almost white powder with a pK a1 of 4.4 and a pK a2 of 10.1. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (Octanol : Water) is – 1.0. 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 pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the orange & red capsule shells contain red iron oxide. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. pregabalin-chem-structure.jpg

Prochlorperazine Maleate PROCHLORPERAZINE MALEATE
MAJOR PHARMACEUTICALS FDA Rx Only

Prochlorperazine, USP is a phenothiazine derivative, present in prochlorperazine tablets as the maleate. Prochlorperazine maleate is designated chemically as 2-chloro-10-[3-(4-methyl-1-piperazinyl)propyl] phenothiazine maleate [molecular weight 606.10] and has the following structure Prochlorperazine Maleate is classified as an anti-emetic and antipsychotic agent. Prochlorperazine maleate is white or pale yellow, practically odorless crystalline powder. It is practically insoluble in water and in alcohol, slightly soluble in warm chloroform. Each tablet, for oral administration contains prochlorperazine maleate equivalent to 5 mg or 10 mg of prochlorperazine. In addition, each tablet contains the following inactive ingredients: hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, partially pregelatinized maize starch, polyethylene glycol and titanium dioxide. FDA approved dissolution test specifications differ from USP. structure

Promethazine Hydrochloride PROMETHAZINE HYDROCHLORIDE
MAJOR PHARMACEUTICALS FDA Rx Only

Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as (±)-10- [2-(Dimethylamino)propyl]phenothiazine monohydrochloride and has the following structural formula: Promethazine hydrochloride is a racemic compound; the molecular formula is C 17 H 20 N 2 S HCl and its molecular weight is 320.88 g/mol. Promethazine hydrochloride, USP occurs as a white to faint yellowish crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether. Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg promethazine hydrochloride, USP. The inactive ingredients include: lactose anhydrous, magnesium stearate, and microcrystalline cellulose. The 50 mg also contains D&C Red # 27 Lake. 1

Propranolol Hydrochloride PROPRANOLOL HYDROCHLORIDE
MAJOR PHARMACEUTICALS FDA Rx Only

Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its structural formula is: Propranolol hydrochloride, USP is a stable, white to off-white, crystalline powder which is readily soluble in water and ethanol. Propranolol Hydrochloride Tablets, USP are available as tablets for oral administration containing either 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg of propranolol hydrochloride, USP. Propranolol Hydrochloride Tablets, USP also contain lactose anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. Color additives include FD&C Yellow no. 6 aluminum lake (10 mg and 80 mg), D&C Yellow no. 10 aluminum lake (10 mg, 40 mg, and 80 mg), FD&C Blue no. 1 aluminum lake (20 mg and 40 mg) and FD&C Red no. 40 aluminum lake (60 mg). 1

Pseudoephedrine HCl Unit Dose PSEUDOEPHEDRINE HCL

Uses temporarily relieves sinus congestion and pressure temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

Pseudoephedrine Hydrochloride PSEUDOEPHEDRINE HYDROCHLORIDE
MAJOR PHARMACEUTICALS FDA OTC

Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure

Pseudoephedrine hydrochloride PSEUDOEPHEDRINE HYDROCHLORIDE
MAJOR PHARMACEUTICALS FDA OTC

Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure

Pseudoephedrine Hydrochloride PSEUDOEPHEDRINE HYDROCHLORIDE
MAJOR PHARMACEUTICALS FDA OTC

Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure

pyridostigmine bromide PYRIDOSTIGMINE BROMIDE
MAJOR PHARMACEUTICALS FDA Rx Only

Pyridostigmine bromide tablets, USP are an orally active cholinesterase inhibitor. Chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural formula is: Pyridostigmine bromide, USP is a white or almost white crystalline, deliquescent powder. It is very soluble in water and in alcohol, slightly soluble in hexane, practically insoluble in ether. Each pyridostigmine bromide tablet, USP intended for oral administration contains 60 mg of pyridostigmine bromide, USP. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, low substituted hydroxypropyl cellulose, silicon dioxide and stearic acid. figure

Quetiapine QUETIAPINE
50 mg Extended-release
MAJOR PHARMACEUTICALS FDA Rx Only

Quetiapine fumarate is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [ b,f ] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C 42 H 50 N 6 O 4 S 2 . C 4 H 4 O 4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is: Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine extended-release tablets are supplied for oral administration as 50 mg (peach to red), 150 mg (white), 200 mg (yellow), 300 mg (yellow to pale yellow), and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients for quetiapine extended-release tablets are hypromellose, hypromellose 2208, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium citrate dihydrate. The film coating for all quetiapine extended-release tablets contain hypromellose 2910, macrogol and titanium dioxide. In addition, red iron oxide (for 50 mg) and yellow iron oxide (for 50 mg, 200 mg and 300 mg) are included in the film coating of specific strengths. Each 50 mg film-coated tablet contains 58 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 150 mg film-coated tablet contains 173 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg film-coated tablet contains 230 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg film-coated tablet contains 345 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg film-coated tablet contains 461 mg of quetiapine fumarate equivalent to 400 mg quetiapine. USP Dissolution Test Pending. Image

Quetiapine QUETIAPINE
25 mg Tablet
MAJOR PHARMACEUTICALS FDA Rx Only

Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [ b,f ] [1,4]thiazepin-11-yl-1-piperazinyl) ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C 42 H 50 N 6 O 4 S 2 •C 4 H 4 O 4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is: Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP is supplied for oral administration as 25 mg (round peach), 50 mg (round, white), 100 mg (round yellow), 150 mg (round, off white to light yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg, 150 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.70 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.27 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.40 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.54 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine. Structure

Raloxifene hydrochloride RALOXIFENE HYDROCHLORIDE
MAJOR PHARMACEUTICALS FDA Rx Only

Raloxifene Hydrochloride is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The chemical structure is: The chemical designation is methanone, [6-hydroxy-2-(4-hydroxyphenyl)benzo[ b ]thien-3-yl]-[4-[2-(1-piperidinyl)ethoxy]phenyl]-, hydrochloride. Raloxifene hydrochloride (HCl) has the empirical formula C 28 H 27 NO 4 S•HCl, which corresponds to a molecular weight of 510.04. Raloxifene Hydrochloride USP is an almost white to pale yellow powder that freely soluble in dimethyl sulfoxide, practically insoluble in ether and in ethyl acetate. Raloxifene hydrochloride tablets USP, 60 mg is supplied in a tablet dosage form for oral administration. Each raloxifene hydrochloride tablets USP, 60 mg contains 60 mg of raloxifene HCl, which is the molar equivalent of 55.71 mg of free base. Inactive ingredients include citric acid monohydrate, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide. USP Dissolution Test is pending. Chemical Structure

Ramelteon RAMELTEON
8 mg Tablet
MAJOR PHARMACEUTICALS FDA Rx Only

Ramelteon is an orally active hypnotic chemically designated as ( S )- N -[2-(1, 6, 7, 8 tetrahydro-2 H -indeno-[5, 4- b ]furan-8-yl)ethyl]propionamide and containing one chiral center. The compound is produced as the ( S )-enantiomer, with an molecular formula of C 16 H 21 NO 2 , molecular weight of 259.34, and the following chemical structure: Ramelteon is a white to cream color powder and it is freely soluble in methanol and practically insoluble in water. Each film-coated tablet contains 8 mg ramelteon and contains following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, ferrosoferric oxide, hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch (botanical source: maize), sodium stearyl fumarate, titanium dioxide. Image

Ranolazine RANOLAZINE
500 mg Extended-release
MAJOR PHARMACEUTICALS FDA Rx Only

Ranolazine is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N ‑ (2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an empirical formula of C 24 H 33 N 3 O 4 , a molecular weight of 427.54 g/mole, and the following structural formula: Ranolazine is a white to off-white solid. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran, ethanol, acetonitrile, and acetone; slightly soluble in ethyl acetate, isopropanol, toluene, and ethyl ether; and very slightly soluble in water. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: colloidal silicon dioxide, hypromellose, iron oxide yellow, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium hydroxide, talc, titanium dioxide and additional inactive ingredients for the 500 mg tablet include iron oxide red. ranolazine-structure

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