epic pharma, llc - Medication Listings

Guanfacine hydrochloride is a centrally acting antihypertensive with α 2 -adrenoceptor agonist properties in tablet form for oral administration. The chemical name of guanfacine hydrochloride is N-Amidino-2-(2,6-dichlorophenyl) acetamide monohydrochloride and its molecular weight is 282.55. Its structural formula is: Guanfacine hydrochloride is a white to off-white powder; sparingly soluble in water and alcohol and slightly soluble in acetone. Each tablet, for oral administration, contains guanfacine hydrochloride equivalent to 1 mg or 2 mg guanfacine. The tablets contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, partially pregelatinized starch, magnesium stearate and talc. Structural Formula

Hydrocodone bitartrate and acetaminophen is available in tablet form for oral administration. Hydrocodone bitartrate, USP is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α-epoxy-3-methoxy-17-methylm orphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula: C 18 H 21 NO 3 •C 4 H 6 O 6 •2½H 2 O M.W. = 494.49 Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C 8 H 9 NO 2 M.W. = 151.16 Each hydrocodone bitartrate and acetaminophen tablets USP, 5 mg/325 mg contains: Hydrocodone Bitartrate ...... 5 mg Acetaminophen ................. 325 mg Each hydrocodone bitartrate and acetaminophen tablets USP, 7.5 mg/325 mg contains: Hydrocodone Bitartrate ......... 7.5 mg Acetaminophen ................ 325 mg Each hydrocodone bitartrate and acetaminophen tablets USP, 10 mg/325 mg contains: Hydrocodone Bitartrate .......... 10 mg Acetaminophen .............. 325 mg In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid. In addition, the 5 mg/325 mg strength contains sugar spheres which are composed of starch derived from corn, sugar, and FD&C Yellow #6. The 7.5 mg/325 mg strength contains FD&C Yellow #6 Aluminum Lake. The 10 mg/325 mg strength contains FD&C Yellow #10 Aluminum Lake. Meets USP Dissolution Test 2. hydrocodone-structure-formula.jpg acetaminophen-structure-formula.jpg

Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-( p -Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. C 21 H 27 CIN 2 O 2 ·2HCl M.W. 447.83 Hydroxyzine hydrochloride, USP occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine hydrochloride, USP. Inactive ingredients include carnauba wax, colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, D&C Yellow #10 Aluminum Lake (25 mg and 50 mg), FD&C Blue #2 Aluminum Lake (25 mg), FD&C Red #40 Aluminum Lake (50 mg), FD&C Yellow #6 Aluminum Lake (10 mg and 50 mg), hypromellose, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide, triacetin and yellow iron oxide (10 mg). Structural Formula

Icosapent ethyl, a lipid-regulating agent, is supplied as a either a 0.5 gram or a 1 gram, clear natural, liquid-filled soft gelatin capsule for oral administration. Each icosapent ethyl capsule contains either 0.5 grams of icosapent ethyl (in a 0.5 gram capsule) or 1 gram of icosapent ethyl (in a 1 gram capsule). Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C 22 H 34 O 2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate with the following chemical structure: Icosapent ethyl capsules contain the following inactive ingredients: gelatin, glycerin, light mineral oil, isopropyl alcohol, nitrogen, purified water, sorbitol sorbitan solution (mannitol, sorbitol, 1,4-sorbitan and water), and white ink. The compositions of white ink are isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac and titanium dioxide. structure-formula.jpg

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei. The molecular formula for Nystatin is C 47 H 75 NO 17 . The molecular weight of Nystatin is 926.09. Structural formula: KLAYESTA is for dermatologic use. KLAYESTA contains 100,000 USP nystatin units per gram. Inactive ingredients: magnesium stearate and light kaolin. structural-formula.jpg

Labetalol Hydrochloride Tablets, USP are an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride is a racemate, chemically designated as 5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino] ethyl] salicylamide monohydrochloride, and has the following structure: Labetalol hydrochloride has the empirical formula C 19 H 24 N 2 O 3 •HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R’ stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride is a white or off-white crystalline powder, soluble in water. Labetalol Hydrochloride Tablets, USP contain 100 mg, 200 mg, or 300 mg labetalol hydrochloride, USP and are taken orally. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, macrogol/PEG, magnesium stearate, polyvinyl alcohol-part hydrolyzed, pregelatinized starch NF, modified corn starch, talc, titanium dioxide. L:\Labeling Department\ANDA\Labetalol\Blu\SBS\Package insert\Epic's Structure.PNG

Leucovorin calcium tablets USP contain either 5 mg, 10 mg, 15 mg or 25 mg leucovorin as the calcium salt of N -[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]- L -glutamic acid. This is equivalent to either 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose anhydrous, magnesium stearate, and microcrystalline cellulose. Leucovorin is a water-soluble form of reduced folate in the folate group; it is useful as an antidote to drugs which act as folic acid antagonists. These tablets are intended for oral administration only. The structural formula of leucovorin calcium is: C 20 H 21 CaN 7 O 7 MW 511.51 leucovorin\structural.jpg

Meclizine hydrochloride, a histamine (H1) receptor antagonist, is a white or slightly yellowish, crystalline powder. It has the following structural formula: Chemically, meclizine hydrochloride is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate. Meclizine hydrochloride tablets, USP are available in two different strengths, 12.5 mg and 25 mg. Inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium and magnesium stearate. The 12.5 mg tablet also contains FD&C Blue #1 Aluminum Lake. structure

Meperidine hydrochloride tablet is an opioid agonist, available as 50 mg and 100 mg tablets for oral administration. The chemical name is 4-Piperidinecarboxylic acid, 1-methyl-4-phenyl-,ethyl ester, hydrochloride. The molecular weight is 283.80. Its molecular formula is C 15 H 21 NO 2 •HCl, and it has the following chemical structure. Meperidine hydrochloride is a white crystalline substance with a melting point of 186°C to 189°C. It is readily soluble in water and has a neutral reaction and a slightly bitter taste. The solution is not decomposed by a short period of boiling. The tablets contain 50 mg or 100 mg of meperidine hydrochloride. The inactive ingredients in meperidine hydrochloride tablets include: pregelatinized starch, microcrystalline cellulose, lactose monohydrate, silicon dioxide and stearic acid. chemistry structure.jpg

Methadone hydrochloride tablets contain methadone, an opioid agonist, available as 5 and 10 mg tablets for oral administration. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-hepatanone hydrochloride. Methadone hydrochloride USP is a white, crystalline material that is water-soluble. Its molecular formula is C 21 H 27 NO• HCl and it has a molecular weight of 345.91. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula: Each methadone hydrochloride tablet contains 5 or 10 mg of methadone hydrochloride USP and the following inactive ingredients: magnesium stearate, microcrystalline cellulose, and pregelatinized starch. structural formula

Methylprednisolone Tablets contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone occurs as a white to practically white, odorless, crystalline powder. It is sparingly soluble in alcohol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water. The chemical name for methylprednisolone is pregna-1, 4-diene-3, 20-dione, 11, 17, 21-trihydroxy-6-methyl-, (6α, 11β)-and the molecular weight is 374.48. The structural formula is represented below: Each Methylprednisolone tablet for oral administration contains 4mg of methylprednisolone. Inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate-Cellulose Microcrystalline, Magnesium Stearate, Croscarmellose Sodium. Meets USP Dissolution Test 2. Structural Formula

Molindone Hydrochloride is a dihydroindolone compound which is not structurally related to the phenothiazines, the butyrophenones or the thioxanthenes. Molindone Hydrochloride is 3-ethyl-6, 7-dihydro-2-methyl-5-(morpholinomethyl) indol-4(5H)-one hydrochloride. It is a white to off-white or pale-pink crystalline powder, freely soluble in water and alcohol. Molindone Hydrochloride Tablets, USP contain the following inactive ingredients: alginic acid, calcium sulfate, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. Colors: 5 mg contains FD&C Yellow #6 Aluminum Lake 10 mg contains FD&C Blue #2 Aluminum Lake 25 mg contains FD&C Blue #2 Aluminum Lake, FD&C Yellow #6, Aluminum Lake and D&C Yellow #10 Aluminum Lake Molindone Hydrochloride is represented by the following structural formula: The empirical formula is C 16 H 24 N 2 O 2 •HCl representing a molecular weight of 312.83. structure formula.jpg

Nicardipine hydrochloride capsules for oral administration each contain 20 mg or 30 mg of nicardipine hydrochloride. Nicardipine hydrochloride capsules are a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Nicardipine hydrochloride is a dihydropyridine structure with the IUPAC (International Union of Pure and Applied Chemistry) chemical name 2-(benzyl-methyl amino)ethyl methyl 1,4-dihydro-2,6-dimethyl-4-(m-nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride, and it has the following structure: Nicardipine hydrochloride is a greenish-yellow, odorless, crystalline powder that melts at about 169°C. It is freely soluble in chloroform, methanol and glacial acetic acid, sparingly soluble in anhydrous ethanol, slightly soluble in n-butanol, water, 0.01 M potassium dihydrogen phosphate, acetone and dioxane, very slightly soluble in ethyl acetate, and practically insoluble in benzene, ether and hexane. It has a molecular weight of 515.99. Each capsule, for oral administration, contains 20 mg or 30 mg of nicardipine hydrochloride. In addition, each capsule contains the following inactive ingredients: magnesium stearate, pregelatinized starch, titanium dioxide, gelatin and FD&C Blue #1. The colorants used in the capsules are black iron oxide, FD&C Blue #2, FD&C Red #40, D&C Yellow #10 and FD&C Blue #1. In addition, the 30 mg capsules also contain propylene glycol. Structure Formula

Nizatidine, USP is a histamine H 2 -receptor antagonist. Chemically, it is N-[2-[[[2-[(dimethylamino)methyl]-4-thiazolyl]methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine. The structural formula is as follows: Nizatidine, USP has the empirical formula C 12 H 21 N 5 O 2 S 2 representing a molecular weight of 331.46. It is an off white to buff crystalline solid that is soluble in water. Nizatidine has a bitter taste and mild sulfur-like odor. Each capsule for oral administration contains nizatidine, USP, 150 mg (0.45 mmol) or 300 mg (0.91 mmol), croscarmellose sodium, corn starch, dimethicone, partially pregelatinized starch (Corn), povidone, talc. Ingredients for 150 mg capsule shell: gelatin, iron oxide yellow, titanium dioxide. Ingredients for 300 mg capsule shell: D&C red 28, FD&C blue 1, FD&C yellow 6, gelatin, titanium dioxide. Ingredients for 150 mg capsule shell: gelatin, iron oxide yellow, titanium dioxide. Ingredients for 300 mg capsule shell: D&C red 28, FD&C blue 1, FD&C yellow 6, gelatin, titanium dioxide. Ingredients for the ink used in capsule printing are ammonia solution concentrated, butyl alcohol, black iron oxide, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide, shellac. Structure

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei. The molecular formula for Nystatin is C 47 H 75 NO 17 . The molecular weight of Nystatin is 926.09. Structural formula: Nystatin topical powder is for dermatologic use. Nystatin topical powder contains 100,000 USP nystatin units per gram. Inactive ingredients: magnesium stearate and light kaolin. structure-formula.jpg

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei. The molecular formula for Nystatin is C 47 H 75 NO 17 . The molecular weight of Nystatin is 926.09. Structural formula: Nystatin topical powder is for dermatologic use. Nystatin topical powder contains 100,000 USP nystatin units per gram dispersed in talc. nystatin-topical-powder-structural-formula

Omega-3-acid ethyl esters, USP, a lipid-regulating agent, is supplied as a liquid-filled gel capsule for oral administration. Each 1-gram capsule of omega-3-acid ethyl esters 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: gelatin, glycerin and purified water. The imprinting ink contains the following: propylene glycol, shellac glaze and titanium dioxide. EPA.jpg DHA.jpg

Oseltamivir phosphate capsules, 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, partially pregelatinized starch, povidone k-30, sodium stearyl fumarate and talc. The 30 mg capsule shell contains gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. The 45 mg capsule shell contains black iron oxide, gelatin, and titanium dioxide. The 75 mg capsule shell contains contains black iron oxide, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. Each capsule is printed with blue ink, which includes FD&C blue #2 aluminum lake, propylene glycol, and shellac. Oseltamivir phosphate is a white crystalline solid 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 28 N 2 O 4 (free base). The molecular weight is 312.4 for oseltamivir free base and 410.4 for oseltamivir phosphate salt. The structural formula is as follows: FDA approved dissolution test specifications differ from USP. structure-formula.jpg

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, sodium benzoate, saccharin sodium, sorbitol, titanium dioxide, tutti frutti type FLVP, xanthan gum. Oseltamivir phosphate is a white crystalline solid 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 28 N 2 O 4 (free base). The molecular weight is 312.4 for oseltamivir free base and 410.4 for oseltamivir phosphate salt. The structural formula is as follows: structure-formula.jpg

Oxcarbazepine Oral Suspension is an antiepileptic drug available as a 300 mg/5 mL (60 mg/mL) oral suspension. Oxcarbazepine is 10,11-Dihydro-10-oxo- 5 H -dibenz[b, f ]azepine-5-carboxamide, and its structural formula is: Oxcarbazepine, USP 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. Oxcarbazepine oral suspension, USP contains the following inactive ingredients: hydroxyethyl cellulose and carboxymethylcellulose sodium, propylene glycol, methylparaben, propylparaben, PEG-400 monostearate, sorbic acid, sorbitol solution, saccharin sodium dihydrate, ascorbic acid, lemon N&A flavor, purified water, microcrystalline cellulose and nitrogen Oxcarbazepine structural formula

Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: Oxycodone Hydrochloride, USP 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP 325 mg Oxycodone Hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP 325 mg Oxycodone Hydrochloride, USP 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP 325 mg All strengths of oxycodone and acetaminophen tablets, USP also contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid. In addition, the 5 mg/325 mg strength contains FD&C Blue No. 1 Aluminum Lake and the 7.5 mg/325 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength contains D&C Yellow No. 10 Aluminum Lake. Oxycodone Hydrochloride 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 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula: Oxycodone Hydrochloride and Acetaminophen Tablets, USP contain acetaminophen, 4’-hydroxyacetanilide, 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 151.16. It may be represented by the following structural formula: USP Dissolution Test pending. image-01.jpg image-02.jpg

Oxycodone and Aspirin Tablets are an immediate-release opioid agonist intended for oral administration only. Each Oxycodone and Aspirin Tablet contains: Oxycodone Hydrochloride, USP 4.8355 mg* Aspirin, USP 325 mg *4.8355 mg oxycodone HCl is equivalent to 4.3346 mg of oxycodone as the free base. Oxycodone and Aspirin Tablets USP also contain the following inactive ingredients: microcrystalline cellulose, starch and zinc stearate. C 18 N 21 NO 4 •HCl MW 351.82 The oxycodone hydrochloride component is Morphinan-6-one, 4,5-epoxy-14-hydroxy-3-methoxy-17-methyl-, hydrochloride, (5α)-, a white to off-white, hygroscopic crystals or powder, odorless, soluble in water; slightly soluble in alcohol and is represented by the following structural formula: C 9 H 8 O 4 MW 180.16 oxy-hydoco.jpg aspirin.jpg

Oxycodone hydrochloride tablets, USP contain 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 is a white, odorless 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). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula: Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg, of oxycodone hydrochloride USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and partially pregelatinized starch. The 10 mg tablet also contains D&C Yellow No. 10 Aluminum Lake. The 15 mg tablet also contains FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and D&C Yellow No. 10 Aluminum Lake. The 20 mg tablet also contains FD&C Red No. 40 Aluminum Lake, FD&C Blue No.2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. The 30 mg tablet also contains FD&C Blue No. 1 Aluminum Lake. oxycodone-chemical- image.jpg

Oxymorphone Hydrochloride Tablets are an opioid agonist available in 5 mg and 10 mg tablet strengths for oral administration. The chemical name for oxymorphone hydrochloride is 4, 5α-epoxy-3, 14-dihydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 337.80. The molecular formula is C 17 H 19 NO 4 • HCl and it has the following chemical structure. Oxymorphone hydrochloride is white to off white odorless powder, which is sparingly soluble in alcohol and ether, but freely soluble in water. The inactive ingredients in oxymorphone hydrochloride tablets include: lactose monohydrate, magnesium stearate, pregelatinized starch‑and sodium lauryl sulfate. In addition, the 5 mg tablets contain iron oxide red #30. The 10 mg tablets contain D&C yellow #10 aluminum lake. FDA approved dissolution test specifications differ from USP. structure-formula.jpg

Phentermine hydrochloride USP is a sympathomimetic amine anorectic. Its chemical name is α,α,-Dimethylphenethylamine hydrochloride. The structural formula is as follows: C 10 H 15 N•HCl M.W. 185.7 Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as a capsule containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). In addition, each capsule contains the following inactive ingredients: lactose monohydrate, magnesium stearate and talc. The capsule shell is composed of D&C Red No. 33, FD&C Blue No.1, titanium dioxide and gelatin. The imprinting ink contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No.1 Aluminum Lake, FD&C Blue No.2 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. structural-formula

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, granular 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 insoluble in alcohol. Inactive Ingredients: colloidal silicon dioxide, hydroxypropyl cellulose and hydrogenated vegetable oil. The film coating contains lecithin, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP.

Potassium Chloride is a white granular powder. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Each pouch of light orange mottled powder contains 1.5 g of potassium chloride, USP, which is equivalent to potassium 20 mEq and chloride 20 mEq and the following inactive ingredients: FD&C Yellow #6, sucralose, silicon dioxide, maltodextrin, citric acid, and orange flavor.

Protriptyline HCl is N-methyl-5H dibenzo[a,d]-cycloheptene-5-propanamine hydrochloride. Its molecular formula is C 19 H 21 N•HCl and its structural formula is: Protriptyline HCl, a dibenzocycloheptene derivative, has a molecular weight of 299.84. It is a white to yellowish powder that is freely soluble in water and soluble in dilute HCl. Protriptyline HCl is supplied as 5 mg or 10 mg film-coated tablets. Inactive ingredients are microcrystalline cellulose, pregelatinized starch, lactose monohydrate, dibasic calcium phosphate, sodium starch glycolate, magnesium stearate, hypromellose, triacetin, polysorbate, titanium dioxide and FD & C yellow 6 aluminum lake. The 10 mg tablet also contains polyethylene glycol and polysorbate 80. structural formula

Quinidine is an antimalarial schizonticide and an antiarrhythmic agent with class 1A activity; it is the d-isomer of quinine, and its molecular weight is 324.43. Quinidine sulfate is the sulfate salt of quinidine; its chemical name is cinchonan-9-ol, 6’- methoxy-, (9S)-, sulfate (2:1) dihydrate; its structural formula is: Its molecular formula is: C 40 H 48 N 4 O 4 ∙H 2 SO 4 ∙2H 2 O; and its molecular weight is 782.96, of which 82.9% is quinidine base. Quinidine sulfate occurs as fine needle-like, white crystals, frequently cohering in masses, or fine, white powder. It is odorless, has a very bitter taste, and darkens on exposure to light. It is slightly soluble in water, soluble in alcohol and in chloroform, and insoluble in ether. Each tablet, for oral administration, contains 200 mg of quinidine sulfate (equivalent to 166 mg of quinidine base) 300 mg of quinidine sulfate (equivalent to 249 mg of quinidine base). In addition, each tablet contains the following inactive ingredients: confectioner’s sugar, corn starch, microcrystalline cellulose, pregelatinized starch and zinc stearate. structure-formula.jpg

Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C 43 H 58 N 4 O 12 . The chemical name for rifampin is either: 3-[[(4-methyl-1-piperazinyl) imino]methyl]rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13] trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is: Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28. structure-formula.jpg

Sodium Polystyrene Sulfonate Powder, for Suspension is a benzene, diethenyl-polymer, with ethenylbenzene, sulfonated, sodium salt and has the following structural formula: The drug is a cream to light brown finely ground, powdered form of sodium polystyrene sulfonate, a cation-exchange resin prepared in the sodium phase with an in vitro exchange capacity of approximately 3.1 mEq ( in vivo approximately 1 mEq) of potassium per gram. The sodium content is approximately 100 mg (4.1 mEq) per gram of the drug. It can be administered orally or rectally as an enema. One gram of Sodium Polystyrene Sulfonate Powder, for Suspension contains 4.1 mEq of sodium. L:\Labeling Department\ANDA\Sodium Polystyrene Sulfonate_SZ- Done\Epic\Package Insert\2017.10 RLD update\Platimun\Docs for Submission\SBS\Structure

Sotalol hydrochloride tablets, USP (AF) contains sotalol hydrochloride, an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. It is supplied as a white, capsule-shaped tablet for oral administration. Sotalol hydrochloride is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol, and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride is d,l- N -[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C 12 H 20 N 2 O 3 S·HCl and is represented by the following structural formula: Sotalol hydrochloride tablets, USP (AF) contain the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, stearic acid, and magnesium stearate. Structural Formula

Sulfadiazine is an oral sulfonamide antibacterial agent. Each tablet, for oral administration, contains 500 mg sulfadiazine. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, docusate sodium, microcrystalline cellulose, povidone, sodium benzoate, sodium starch glycolate and stearic acid. Sulfadiazine occurs as a white or slightly yellow powder. It is odorless or nearly so and slowly darkens on exposure to light. It is practically insoluble in water and slightly soluble in alcohol. The chemical name of sulfadiazine is N 1 -2-pyrimidinylsulfanilamide. The molecular formula is C 10 H 10 N 4 O 2 S. It has a molecular weight of 250.27. The structural formula is shown below: Most sulfonamides slowly darken on exposure to light. structure-formula.jpg

Sulindac is a non-steroidal, anti-inflammatory indene derivative designated chemically as (Z)-5-fluoro-2-methyl-1- [[p-(methylsulfinyl) phenyl]methylene] -1 H -indene-3-acetic acid. It is not a salicylate, pyrazolone or propionic acid derivative. Its empirical formula is C 20 H 17 FO 3 S, with a molecular weight of 356.42. Sulindac, a yellow crystalline compound, is a weak organic acid practically insoluble in water below pH 4.5, but very soluble as the sodium salt or in buffers of pH 6 or higher. Sulindac is available in 150 and 200 mg tablets for oral administration. Each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, plasdone and sodium starch glycolate. Following absorption, sulindac undergoes two major biotransformations - reversible reduction to the sulfide metabolite, and irreversible oxidation to the sulfone metabolite. Available evidence indicates that the biological activity resides with the sulfide metabolite. The structural formulas of sulindac and its metabolites are: structural-formula

Tapentadol tablets are a mu-opioid receptor agonist, available in immediate-release film-coated tablets for oral administration, containing 58.24, 87.36 and 116.48 mg of tapentadol hydrochloride in each tablet strength, equivalent to 50, 75, and 100 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R, 2R)-3-(dimethylamino)-1-ethyl-2- methylpropyl] phenol monohydrochloride, and it has the following chemical structure: The molecular weight of tapentadol hydrochloride is 257.80, and the molecular formula is C 14 H 23 NO·HCl. The n-octanol: water partition coefficient log P value is 2.87. The pKa values are 9.34 and 10.45. The inactive ingredients in tapentadol tablets include: colloidal silicon dioxide, copovidone, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The film coatings for all tablet strengths contain macrogol/peg 4000, polyvinyl alcohol-part hydrolyzed, talc, titanium dioxide; the film coatings for the 50 mg tablets also contain caramel; the film coatings for the 75 mg tablets contain D&C yellow #10 aluminum lake and FD&C red #40/allura red AC aluminum lake; the film coatings for the 100 mg tablets contain FD&C red #40/allura red AC aluminum lake and FD&C yellow #6/sunset yellow FCF aluminum lake. structure-formula.jpg

Trandolapril is the ethyl ester prodrug of a nonsulfhydryl angiotensin converting enzyme (ACE) inhibitor, trandolaprilat. Trandolapril is chemically described as (2S, 3aR, 7aS)-1-[(S)-N-[(S)-1-Carboxy-3-phenylpropyl]alanyl] hexahydro-2-indolinecarboxylic acid, 1- ethyl ester. Its empirical formula is C 24 H 34 N 2 O 5 and its structural formula is: M.W. = 430.54 Melting Point = 125°C Trandolapril is a white or almost white powder that is soluble (> 100 mg/mL) in chloroform, dichloromethane, and methanol. Trandolapril tablets contain 1 mg, 2 mg, or 4 mg of trandolapril USP for oral administration. Each tablet also contains corn starch, croscarmellose sodium, hypromellose, ferric oxide red, lactose monohydrate, povidone and sodium stearyl fumarate. Structural Formula - Trandolapril

Ursodiol is a bile acid available as 300 mg capsules suitable for oral administration. Ursodiol, USP (ursodeoxycholic acid), is a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. It is a bitter-tasting, white powder freely soluble in ethanol, methanol, and glacial acetic acid; sparingly soluble in chloroform; slightly soluble in ether; and insoluble in water. The chemical name for ursodiol is 3α, 7β-Dihydroxy-5β-cholan-24-oic acid (C 24 H 40 O 4 ). Ursodiol, USP has a molecular weight of 392.57. Its structure is shown below: Inactive Ingredients: Corn starch, magnesium stearate, silicon dioxide and the capsule shell contain the following ingredients, gelatin, titanium dioxide, D&C Red # 28, FD&C Blue # 1 and FD&C Red # 40. The imprinting ink contains the following: black iron oxide, D&C Yellow # 10 Aluminum Lake, FD&C Blue # 1 Aluminum Lake, FD&C Blue # 2 Aluminum Lake, FD&C Red # 40 Aluminum Lake, propylene glycol and shellac glaze. structural-formula

Venlafaxine Hydrochloride Extended-Release Capsules, USP are an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17 H 27 NO 2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows: Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of empty hard gelatin capsules, ethylcellulose, hypromellose, povidone, sugar spheres (composed of corn starch and sucrose) and talc. The 37.5 mg capsule shell contains red iron oxide, gelatin, and titanium dioxide. The 75 mg capsule shell contains black iron oxide, red iron oxide, gelatin, and titanium dioxide. The 150 mg capsule shell contains FD&C blue 1, FD&C red 3, FD&C yellow 6, gelatin, and titanium dioxide. The imprinting ink contains black iron oxide, potassium hydroxide and shellac. FDA approved dissolution test specifications differ from USP. image-01