ingenus pharmaceuticals, llc - Medication Listings

Browse 71 medications manufactured by ingenus pharmaceuticals, llc. Open a product record to review dosage forms, strengths, packaging, and related navigation.

Nifedipine NIFEDIPINE
INGENUS PHARMACEUTICALS, LLC FDA Rx Only

Nifedipine extended-release tablets, USP are an extended release tablet dosage form of the calcium channel blocker nifedipine. 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: Product meets USP dissolution test 10. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended release tablets contain either: 30, 60, or 90 mg of nifedipine for once-a-day oral administration. Inert ingredients in the 30mg nifedipine extended-release tablet formulation are lactose monohydrate, microcrystalline cellulose, hypromellose, magnesium stearate, polyvinyl alcohol, talc, titanium dioxide, macrogol/polyethylene glycol 3350, lecithin (soy), iron oxide yellow and iron oxide black. Inert ingredients in the 60mg nifedipine extended-release tablet formulation are lactose monohydrate, microcrystalline cellulose, hypromellose, magnesium stearate, polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylene glycol 3350, lecithin (soy), iron oxide red, iron oxide black and iron oxide yellow. Inert ingredients in the 90mg nifedipine extended-release tablet formulation are: lactose monohydrate, microcrystalline cellulose, hypromellose, magnesium stearate, polyvinyl alcohol, iron oxide red, talc, macrogol/polyethylene glycol 3350, iron oxide yellow, titanium dioxide, lecithin (soy) and iron oxide black. image1

NITRO-DUR NITROGLYCERIN
INGENUS PHARMACEUTICALS, LLC FDA Rx Only

Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is: and whose molecular weight is 227.09. The organic nitrates are vasodilators, active on both arteries and veins. The NITRO-DUR ® (nitroglycerin) Transdermal Infusion System is a flat unit designed to provide continuous controlled release of nitroglycerin through intact skin. The rate of release of nitroglycerin is linearly dependent upon the area of the applied system; each cm 2 of applied system delivers approximately 0.02 mg of nitroglycerin per hour. Thus, the 5-,10-, 15-, 20-, 30-, and 40-cm2 systems deliver approximately 0.1, 0.2, 0.3, 0.4, 0.6, and 0.8 mg of nitroglycerin per hour, respectively. The remainder of the nitroglycerin in each system serves as a reservoir and is not delivered in normal use. After 12 hours, for example, each system has delivered approximately 6% of its original content of nitroglycerin. The NITRO-DUR transdermal system contains nitroglycerin in acrylic-based polymer adhesives with a resinous cross-linking agent to provide a continuous source of active ingredient. Each unit is sealed in a paper polyethylene-foil pouch. Cross section of the system. nitroglycerin chemical structure cross section of system

Norethindrone acetate NORETHINDRONE ACETATE
INGENUS PHARMACEUTICALS, LLC FDA Rx Only

Norethindrone acetate tablets, USP - 5 mg oral tablets. Norethindrone acetate, USP (17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one acetate), a synthetic, orally active progestin, is the acetic acid ester of norethindrone. It is a white to yellowish-white, crystalline powder. Norethindrone acetate tablets, USP contain the following inactive ingredients: lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Meets USP dissolution Test 2. structure

Oxaliplatin OXALIPLATIN
50 mg/10 ml Injection
INGENUS PHARMACEUTICALS, LLC FDA Rx Only

Oxaliplatin,USP is a platinum-based drug with the chemical name of cis- [(1 R, 2 R )-1,2-cyclohexanediamine- N,N' ] [oxalato(2-)- O,O' ] platinum. Oxaliplatin, USP is an organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane (DACH) and with an oxalate ligand as a leaving group. The molecular weight is 397.3. Oxaliplatin, USP is slightly soluble in water at 6 mg/mL, very slightly soluble in methanol, and practically insoluble in ethanol and acetone. Oxaliplatin injection, USP for intravenous use is supplied in a single-dose vial containing 50 mg or 100 mg of oxaliplatin as a sterile, preservative-free, aqueous solution at a concentration of 5 mg/mL. The pH is 4.0 to 7.0. Lactose monohydrate is present as an inactive ingredient at 450 mg and 900 mg in the 50 mg and 100 mg dosage strengths, respectively. Water for Injection, USP is also present as an inactive ingredient. image

Oxcarbazepine OXCARBAZEPINE
150 mg Extended-release
INGENUS PHARMACEUTICALS, LLC FDA Rx Only

Oxcarbazepine is an antiepileptic drug (AED). Oxcarbazepine extended-release tablets contain oxcarbazepine for once-a-day oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]-azepine-5-carboxamide, and its structural formula is Oxcarbazepine is Light orange to creamish white or Off-white powder. Oxcarbazepine is sparingly soluble in chloroform (30-100 g/L). In aqueous media over pH range 1 to 8, oxcarbazepine is practically insoluble and its solubility is 40 mg/L (0.04 g/L) at pH 7.0, 25°C. The molecular formula is C 15 H 12 N 2 O 2 and its molecular weight is 252.27. Oxcarbazepine extended-release tablets tablets contain the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, fumaric acid, povidone, hypromellose, colloidal silicon dioxide, magnesium stearate, Carboxymethyl cellulose sodium, polyvinyl alcohol, FD&C Yellow 6 lake, polyethylene glycol, talc, D&C Red No. 30 Lake and titanium dioxide. Image

Pemetrexed PEMETREXED DISODIUM
INGENUS PHARMACEUTICALS, LLC FDA Rx Only

Pemetrexed for Injection, USP is a folate analog metabolic inhibitor. The drug substance, pemetrexed disodium hemipentahydrate, has the chemical name L-glutamic acid, N -[4-[2-(2-amino-4,7-dihydro-4-oxo-1 H -pyrrolo[2,3- d ]pyrimidin-5-yl)ethyl]benzoyl]-, disodium salt, hemipentahydrate with a molecular formula of C 20 H 19 N 5 Na 2 O 6 •2.5H 2 O and a molecular weight of 516.41. The structural formula is as follows: Pemetrexed for Injection, USP is a sterile white to either light yellow or green-yellow lyophilized solid in single-dose vials to be reconstituted for intravenous infusion. Each 100-mg vial of pemetrexed for injection, USP contains 100 mg pemetrexed (equivalent to 120.8 mg pemetrexed disodium hemipentahydrate) and 106 mg mannitol. Each 500-mg vial of pemetrexed for injection, USP contains 500 mg pemetrexed (equivalent to 604 mg pemetrexed disodium hemipentahydrate) and 500 mg mannitol. Hydrochloric acid and/or sodium hydroxide may have been added to adjust pH. Structural Formula

Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide PHENOBARBITAL HYOSCYAMINE SULFATE ATROPINE SULFATE AND SCOPOLAMINE HYDROBROMIDE

Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Tablets Each Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Tablet contains: Phenobarbital, USP ..................................16.2 mg Hyoscyamine Sulfate, USP ......................0.1037 mg Atropine Sulfate, USP ..............................0.0194 mg Scopolamine Hydrobromide, USP ...........0.0065 mg Inactive Ingredients Dibasic Calcium Phosphate Dihydrate, Compressible Sugar, Microcrystalline Cellulose, Sodium Starch Glycolate, Stearic Acid, Silicon Dioxide Colloidal, Magnesium Stearate.

Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide PHENOBARBITAL HYOSCYAMINE SULFATE ATROPINE SULFATE SCOPOLAMINE HYDROBROMIDE

Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir - Grape Each 5 mL (teaspoonful) of elixir (alcohol not more than 23.8%) contains: Phenobarbital, USP................................. 16.2 mg Hyoscyamine Sulfate, USP................ 0.1037 mg Atropine Sulfate, USP......................... 0.0194 mg Scopolamine Hydrobromide, USP.... 0.0065 mg Inactive Ingredients Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Artificial and Natural Grape Flavor, FD&C Red #3, and FD&C Blue #1. Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir – Mint Each 5 mL (teaspoonful) of elixir (alcohol not more than 23.8%) contains: Phenobarbital, USP................................. 16.2 mg Hyoscyamine Sulfate, USP................ 0.1037 mg Atropine Sulfate, USP......................... 0.0194 mg Scopolamine Hydrobromide, USP.... 0.0065 mg Inactive Ingredients Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Natural Mint Flavor, FD&C Yellow #5, and FD&C Blue #1.

Pramipexole dihydrochloride PRAMIPEXOLE DIHYDROCHLORIDE
0.375 mg Extended-release
INGENUS PHARMACEUTICALS, LLC FDA Rx Only

Pramipexole dihydrochloride extended-release tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a non-ergot 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 is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. P ramipexole dihydrochloride extended-release tablets 0.375 mg: Each extended-release tablet contains 0.375 mg pramipexole dihydrochloride monohydrate equivalent to 0.352 mg pramipexole dihydrochloride. P ramipexole dihydrochloride extended-release tablets 0.75 mg: Each extended-release tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.705 mg pramipexole dihydrochloride. P ramipexole dihydrochloride extended-release tablets 1.5 mg: Each extended-release tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride. P ramipexole dihydrochloride extended-release tablets 2.25 mg: Each extended-release tablet contains 2.25 mg pramipexole dihydrochloride monohydrate equivalent to 2.12 mg pramipexole dihydrochloride. P ramipexole dihydrochloride extended-release tablets 3 mg: Each extended-release tablet contains 3 mg pramipexole dihydrochloride monohydrate equivalent to 2.82 mg pramipexole dihydrochloride. P ramipexole dihydrochloride extended-release tablets 3.75 mg: Each extended-release tablet contains 3.75 mg pramipexole dihydrochloride monohydrate equivalent to 3.53 mg pramipexole dihydrochloride. P ramipexole dihydrochloride extended-release tablets 4.5 mg: Each extended-release tablet contains 4.5 mg pramipexole dihydrochloride monohydrate equivalent to 4.23 mg pramipexole dihydrochloride. Inactive ingredients for all strengths of Pramipexole dihydrochloride extended-release tablets consist of hypromellose, corn starch, microcrystalline cellulose, sodium lauryl sulfate, sodium metabisulfite and magnesium stearate. image-01

prednisolone sodium phosphate ODT PREDNISOLONE SODIUM PHOSPHATE
INGENUS PHARMACEUTICALS, LLC FDA Rx Only

Prednisolone sodium phosphate orally disintegrating tablets are a sodium salt of the phosphoester of the glucocorticoid prednisolone. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisolone sodium phosphate occurs as white or slightly yellow, friable granules or powder. It is freely soluble in water; soluble in methanol; slightly soluble in alcohol and in chloroform; and very slightly soluble in acetone and in dioxane. The chemical name of prednisolone sodium phosphate is pregna-1, 4-diene-3, 20-dione, 11, 17-dihydroxy-21-(phosphonooxy)-, disodium salt, (11ß)-. The empirical formula is C 21 H 27 Na 2 O 8 P; the molecular weight is 484.39. Its chemical structure is: Each orally disintegrating tablet also contains the following inactive ingredients: citric acid, colloidal silicon dioxide, crospovidone, grape flavor, hypromellose, magnesium stearate, mannitol, methacrylate copolymer, microcrystalline cellulose, sodium bicarbonate, sucralose, and sucrose. 5

PRIMAQUINE PHOSPHATE PRIMAQUINE PHOSPHATE
INGENUS PHARMACEUTICALS, LLC FDA Rx Only

Primaquine phosphate is 8-[(4-amino-1-methylbutyl) amino]-6-methoxyquinoline phosphate, a synthetic compound with potent antimalarial activity. The molecular formula of primaquine phosphate is C 15 H 21 N 3 O·2H 3 PO 4 and its molecular weight is 455.34. The structural formula of primaquine phosphate is: Figure 1: Primaquine phosphate structure. Each Primaquine phosphate tablet, USP contains 26.3 mg of primaquine phosphate (equivalent to 15 mg of primaquine base). The dosage is customarily expressed in terms of the base. Inactive Ingredients: Hypromellose, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Triacetin, Pregelatinized Starch, FD&C Yellow#6/Sunset Yellow FCF Aluminum Lake, Talc, Titanium Dioxide. Structure

Probenecid and Colchicine PROBENECID AND COLCHICINE
INGENUS PHARMACEUTICALS, LLC FDA Rx Only

Probenecid and colchicine contains probenecid, which is a uricosuric agent, and colchicine, which has antigout activity, the mechanism of which is unknown. Probenecid is the generic name for 4-[(dipropylamino) sulfonyl]benzoic acid. The structural formula is represented below: Probenecid is a white or nearly white, fine crystalline powder. C 13 H 19 NO 4 S M.W. 285.36 It is soluble in dilute alkali, in alcohol, in chloroform, and in acetone; it is practically insoluble in water and in dilute acids. Colchicine is an alkaloid obtained from various species of Colchicum. The chemical name for colchicine is ( S)-N- (5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo[ α ]heptalen-7-yl) acetamide. The structural formula is represented below: C 22 H 25 NO 6 M.W. 399.44 Colchicine consists of pale yellow scales or powder; it darkens on exposure to light. Colchicine is soluble in water, freely soluble in alcohol and in chloroform, and slightly soluble in ether. Each tablet for oral administration contains 500 mg of probenecid and 0.5 mg of colchicine. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and sodium starch glycolate. Probenecid-Structure Colchicine-StructureA

Quetiapine Fumarate QUETIAPINE FUMARATE
50 mg Extended-release
INGENUS PHARMACEUTICALS, LLC 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 is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine extended-release tablets, USP are supplied for oral administration as 50 mg (pink), 150 mg (white), 200 mg (yellow), 300 mg (light yellow) and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients: The following are common in all 5 tablet strengths: microcrystalline cellulose, hypromellose, magnesium stearate, povidone, polyethylene glycol, and titanium dioxide. Additional inactive ingredients include: 50 mg - polyvinyl alcohol, talc, iron oxide yellow, iron oxide red, iron oxide black, lecithin (soya);150 mg - polydextrose and triacetin; 200 mg - polyvinyl alcohol, talc, lecithin (soya), D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake and FD&C blue #2 aluminum lake; 300 mg - polyvinyl alcohol, talc, lecithin (soya), iron oxide yellow and iron oxide black; 400 mg - polydextrose, and triacetin. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.69 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.50 mg of quetiapine fumarate equivalent to 400 mg quetiapine. Meets USP dissolution test 6. Image

QUININE SULFATE QUININE SULFATE
324 mg Capsule
INGENUS PHARMACEUTICALS, LLC FDA Rx Only

Quinine sulfate is a cinchona alkaloid chemically described as cinchonan-9-ol, 6'-methoxy-, (8α, 9R)-, sulfate (2:1) (salt), dihydrate with a molecular formula of (C 20 H 24 N 2 O 2 ) 2 •H 2 SO 4 •2H 2 O and a molecular weight of 782.96. The structural formula of quinine sulfate is: Quinine sulfate occurs as a white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste. It is only slightly soluble in water, alcohol, chloroform, and ether. Quinine sulfate is supplied for oral administration as capsules containing 324 mg of the active ingredient, quinine sulfate, USP, equivalent to 269 mg free base. Inactive ingredients: Pregelatinized starch, colloidal silicon dioxide, and magnesium stearate. The capsule shell contains gelatin and titanium dioxide and are imprinted with black ink. Product meets USP Dissolution Test 2. Image

Scopolamine SCOPOLAMINE
INGENUS PHARMACEUTICALS, LLC FDA Rx Only

Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.5 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.0 2,4 ]nonan-7-yl) 3-hydroxy-2 phenylpropanoate. The empirical formula is C 17 H 21 NO 4 and its structural formula is: Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 2.5 cm 2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing membrane of tan-colored, aluminized, polyester film printed with brown ink; (2) a drug adhesive layer of scopolamine, acrylic adhesive and isopropyl myristate; (3) an ethylene vinyl acetate membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a drug adhesive layer of scopolamine, acrylic adhesive and isopropyl myristate. A release liner of siliconized polyester, which covers the adhesive layer, is removed before the system is used. The brown imprinting ink contains FD&C yellow no. 6 aluminum lake, polyamide resin, polytetrafluoroethylene, polyethylene wax, carbon black and quinacridone red pigment. Cross section of the system: Structure System

Sucralfate SUCRALFATE
1 g/10 ml
INGENUS PHARMACEUTICALS, LLC FDA Rx Only

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

Tafluprost TAFLUPROST
0.015 mg/ml Liquid
INGENUS PHARMACEUTICALS, LLC FDA Rx Only

Tafluprost is a fluorinated analog of prostaglandin F2α. The chemical name for tafluprost is Propan-2-yl (5 Z )-7-{(1 R ,2 R ,3 R ,5 S )-2-[(1 E )-3,3 difluoro-4-phenoxybut-1-enyl]-3,5-dihydroxycyclopentyl}hept-5-enoate. The molecular formula of tafluprost is C 25 H 34 F 2 O 5 and its molecular weight is 452.5. Its structural formula is: Tafluprost is a colorless to yellowish hygroscopic oil that is very soluble in acetone, acetonitrile, dichloromethane, diethylether, ethanol, methanol and tert -butyl(methyl)ether and practically insoluble in n -heptane and water. Tafluprost ophthalmic solution, 0.0015% is supplied as a sterile solution of tafluprost with a pH range of 5.5 to 6.7 and an Osmolality range of 260 to 300 mOsmol/kg. Tafluprost ophthalmic solution contains Active: tafluprost 0.015 mg/mL; Inactives: glycerin, monobasic sodium phosphate dihydrate, edetate disodium dihydrate, polysorbate 80, hydrochloric acid and/or sodium hydroxide (to adjust pH) and Water for Injection. Tafluprost ophthalmic solution does not contain a preservative. Image

Timolol Maleate TIMOLOL MALEATE
INGENUS PHARMACEUTICALS, LLC FDA Rx Only

Timolol maleate, USP is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-( tert -butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate, USP possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is: 25° [α] in 1.0N HCl (C = 5%) = -12.2° (-11.7° to -12.5°) 405 nm Its molecular formula is C 13 H 24 N 4 O 3 S•C 4 H 4 O 4 , and its structural formula is: Timolol maleate, USP has a molecular weight of 432.50. It is a white, or practically white, odorless or practically odorless powder which is soluble in water, in alcohol, and in methanol; sparingly soluble in chloroform and in propylene glycol; insoluble in ether and in cyclohexane. Timolol maleate, USP is stable at room temperature. Timolol maleate ophthalmic solution, USP is supplied in preservative-free formulation. Preservative-free timolol maleate ophthalmic solution, USP is supplied in a single-dose vial, as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths: Each mL of preservative-free timolol maleate ophthalmic solution USP, 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the solution is approximately 7.0, and the osmolarity is 252-328 mOsm. Each mL of preservative-free timolol maleate ophthalmic solution USP, 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic sodium phosphate dihydrate and dibasic sodium phosphate dodecahydrate, sodium hydroxide to adjust pH, and water for injection. Timolol Maleate -Structure

TIZANIDINE HYDROCHLORIDE TIZANIDINE HYDROCHLORIDE
INGENUS PHARMACEUTICALS, LLC FDA Rx Only

Tizanidine contains tizanidine hydrochloride, USP as the active ingredient, which is a central alpha 2 -adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3 benzothiadiazole monohydrochloride. It has a molecular formula of C 9 H 8 ClN 5 S-HCl and a molecular weight of 290.2. Its structural formula is: Tizanidine hydrochloride, USP is a white to slightly yellow crystalline powder. Tizanidine hydrochloride is slightly soluble in water and methanol. Tizanidine hydrochloride capsules are for oral administration and contain 2, 4, or 6 mg tizanidine (equivalent to 2.29 mg, 4.58 mg, and 6.87 mg tizanidine hydrochloride, respectively), and the inactive ingredients, microcrystalline cellulose, anhydrous lactose, colloidal silicon dioxide, stearic acid. In addition, each of the empty hard gelatin capsules contain the following: gelatin, titanium dioxide, sodium lauryl sulfate and FD&C blue #1. The imprinting ink contains the following: shellac, propylene glycol, potassium hydroxide, ammonia and black iron oxide. tizanidine structure

TOLCAPONE TOLCAPONE
INGENUS PHARMACEUTICALS, LLC FDA Rx Only

Tolcapone tablets, USP is available as tablets containing 100 mg tolcapone, USP. Tolcapone, an inhibitor of catechol-O-methyltransferase (COMT), is used in the treatment of Parkinson's disease as an adjunct to levodopa/carbidopa therapy. It is a yellow, non-hygroscopic, fine powder or fine powder with lumps with a relative molecular mass of 273.24. The chemical name of tolcapone is 3,4-dihydroxy-4'-methyl-5-nitrobenzophenone. Its empirical formula is C 14 H 11 NO 5 and its structural formula is: Inactive ingredients: Core: lactose monohydrate, microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, povidone, talc and magnesium stearate.Film coating: hydroxypropyl methylcellulose, titanium dioxide, talc, ethyl cellulose, triacetin,and sodium lauryl sulfate, with the following dye system: yellow iron oxide. Structure

Triazolam TRIAZOLAM
0.125 mg Tablet
INGENUS PHARMACEUTICALS, LLC FDA Rx Only

Triazolam Tablets, USP contains triazolam, a triazolobenzodiazepine. Triazolam, USP is a white crystalline powder, soluble in alcohol and poorly soluble in water. It has a molecular weight of 343.21. The chemical name for triazolam is 8-chloro-6-(o-chlorophenyl)-1-methyl-4H-s-triazolo-[4,3-α] [1,4] benzodiazepine. The structural formula is represented below: structure Each triazolam tablet, for oral administration, contains 0.125 mg or 0.25 mg of Triazolam, USP. Inactive ingredients: 0.125 mg- lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, docusate sodium with sodium benzoate, colloidal silicon dioxide and magnesium stearate; 0.25 mg - lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, FD&C Blue No. 1, docusate sodium with sodium benzoate, colloidal silicon dioxide and magnesium stearate.

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