direct_rx - Medication Listings

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: [Chemical Structure] Molecular Formula: C19H21N5O4•HCl It is white to tan powder, slightly soluble in water, in methanol, in dimethyl formamide, in dimethyl acetamide, very slightly soluble in alcohol, practically insoluble in isotonic saline, in chloroform and in acetone and has a molecular weight of 419.86. 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, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsules contain gelatin and titanium dioxide. In addition, the 2 mg empty gelatin capsules contain FD&C Red No. 40, FD&C Red No. 3 and FD&C Blue No. 1; and the 5 mg empty gelatin capsules contain FD&C Red 3 and FD&C Blue No. 1. The imprinting ink also contains Black Iron Oxide, Potassium Hydroxide, Shellac. FDA approved dissolution test specifications differ from USP.

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: [Chemical Structure] Molecular Formula: C19H21N5O4•HCl It is white to tan powder, slightly soluble in water, in methanol, in dimethyl formamide, in dimethyl acetamide, very slightly soluble in alcohol, practically insoluble in isotonic saline, in chloroform and in acetone and has a molecular weight of 419.86. 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, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsules contain gelatin and titanium dioxide. In addition, the 2 mg empty gelatin capsules contain FD&C Red No. 40, FD&C Red No. 3 and FD&C Blue No. 1; and the 5 mg empty gelatin capsules contain FD&C Red 3 and FD&C Blue No. 1. The imprinting ink also contains Black Iron Oxide, Potassium Hydroxide, Shellac. FDA approved dissolution test specifications differ from USP.

Prednisone tablets, USP contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate, 17,21-dihydroxy-. The structural formula is represented below: [structural formula for prednisone] C21H26O5 M.W. 358.44 Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg of prednisone, USP (anhydrous). In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, docusate sodium, magnesium stearate and sodium benzoate. Prednisone tablets, USP 20 mg also contain FD&C Yellow No. 6.

Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is: [structure] Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and white capsule shells contain sodium lauryl sulfate. Each capsule shell is imprinted with black pharmaceutical ink which contains: butyl alcohol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, propylene glycol, potassium hydroxide, purified water, strong ammonia solution and shellac.

Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is: Chemical Structure Pregabalin is a white to off-white, crystalline powder with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide and sodium lauryl sulfate. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain the colorants FD&C Blue 1, FD&C Red 40 and FD&C Yellow 6. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide.

Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is: [Chemical Structure] Pregabalin is a white to off-white, crystalline powder with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide and sodium lauryl sulfate. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain the colorants FD&C Blue 1, FD&C Red 40 and FD&C Yellow 6. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide.

Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is: [Chemical Structure] Pregabalin is a white to off-white, crystalline powder with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide and sodium lauryl sulfate. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain the colorants FD&C Blue 1, FD&C Red 40 and FD&C Yellow 6. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide.

Chemical name: 5-ethyldihydro-5-phenyl-4,6 (1H, 5H)-pyrimidinedione. Structural formula: [Structural Formula] Primidone is a white, crystalline, highly stable substance, M.P. 279-284°C. It is poorly soluble in water (60 mg per 100 mL at 37°C) and in most organic solvents. It possesses no acidic properties, in contrast to its barbiturate analog. Primidone 50 mg and 250 mg tablets contain the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate and talc. Primidone 250 mg tablets also contain D&C yellow #10 aluminum lake and FD&C yellow #5 aluminum lake.

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 [Structure of Prochlorperazine] 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: D&C yellow no. 10 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C yellow no. 6 aluminum lake, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid and titanium dioxide.

Progesterone capsules contain micronized progesterone for oral administration. Progesterone has a molecular weight of 314.47 and a molecular formula of C21H30O2. Progesterone (pregn-4-ene-3, 20-dione) is a white or creamy white, odorless, crystalline powder practically insoluble in water, soluble in alcohol, acetone and dioxane and sparingly soluble in vegetable oils, stable in air, melting between 126° and 131°C. The structural formula is: [Chemical Structure] Progesterone is synthesized from a starting material from a plant source and is chemically identical to progesterone of human ovarian origin. Progesterone capsules are available in multiple strengths to afford dosage flexibility for optimum management. Progesterone capsules contain 100 mg or 200 mg micronized progesterone and the following inactive ingredients: peanut oil, gelatin, glycerin, soya lecithin, titanium dioxide, and triglyderides medium chain.

Progesterone capsules contain micronized progesterone for oral administration. Progesterone has a molecular weight of 314.47 and a molecular formula of C21H30O2. Progesterone (pregn-4-ene-3, 20-dione) is a white or creamy white, odorless, crystalline powder practically insoluble in water, soluble in alcohol, acetone and dioxane and sparingly soluble in vegetable oils, stable in air, melting between 126° and 131°C. The structural formula is: [Chemical Structure] Progesterone is chemically identical to progesterone of human ovarian origin. Progesterone capsules are available in multiple strengths to afford dosage flexibility for optimum management. Each progesterone capsule for oral administration contains 100 mg or 200 mg of micronized progesterone and the following inactive ingredients: peanut oil, gelatin, glycerin, soya lecithin, titanium dioxide, and triglyderides medium chain.

Progesterone capsules contain micronized progesterone for oral administration. Progesterone has a molecular weight of 314.47 and a molecular formula of C21H30O2. Progesterone (pregn-4-ene-3, 20-dione) is a white or creamy white, crystalline powder or colorless crystals practically insoluble in water, soluble in alcohol, acetone and dioxane and sparingly soluble in vegetable oils, melting between 126º and 131ºC. The structural formula is: [Chemical Structure] Progesterone is synthesized from a starting material from a plant source and is chemically identical to progesterone of human ovarian origin. Progesterone capsules are available in multiple strengths to afford dosage flexibility for optimum management. Progesterone capsules contain 100 mg or 200 mg micronized progesterone USP. The inactive ingredients for progesterone capsules include: gelatin, glycerin, hypromellose, iron oxide black, lecithin, peanut oil, propylene glycol, titanium dioxide.

hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C17H20N2S HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H-Phenothiazine-10-ethanamine, N,N,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. [Structured product formula for Promethazine] Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, 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, in acetone and in ethyl acetate.

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: [chemical-structure] C​16​H​21​NO​2​HCl M.W. 295.80 Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and in 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 colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose. Color additives include FD&C Yellow no. 6 aluminum lake (10 mg and 80 mg), D&C Yellow no. 10 aluminum lake (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).

Propranolol hydrochloride is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its molecular and structural formulae are: [This is the formula for Propranolol Hydrochloride.] Propranolol hydrochloride is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol hydrochloride is available as 10 mg, 20 mg, 40 mg, 60 mg, and 80 mg tablets for oral administration. The inactive ingredients contained in propranolol hydrochloride tablets, USP are: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, D&C Yellow #10 (10 mg, 40 mg and 80 mg tablets), FD&C Blue #1 (20 mg tablet), FD&C Blue #2 (40 mg tablet), FD&C Red #40 (60 mg tablet), FD&C Yellow #6 (10 mg and 80 mg tablets), magnesium stearate, and microcrystalline cellulose.

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 C42H50N6O4S2•C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is: [Chemical Structure] Quetiapine fumarate USP is a white to off-white powder which is moderately soluble in water. Quetiapine is supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 150 mg (round, light yellow), 200 mg (round, white), 300 mg (capsule shaped, white), and 400 mg (capsule shaped, yellow) tablets. Inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose 6cp, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone, sodium starch glycolate, talc, and titanium dioxide. In addition, the 25 mg contains iron oxide red and iron oxide yellow; the 100 mg, 150 mg, and 400 mg contains iron oxide yellow. The 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, and 400 mg tablets are printed with Opacode S-1-17823 black contains iron oxide black and shellac. Each 25 mg tablet contains 28.780 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.561 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.122 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.683 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.244 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.366 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.488 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.

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 C42H50N6O4S2•C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is: [Chemical Structure] Quetiapine fumarate USP is a white to off-white powder which is moderately soluble in water. Quetiapine is supplied for oral administration as 25 mg (round, peach), 50 mg (round, white), 100 mg (round, yellow), 150 mg (round, light yellow), 200 mg (round, white), 300 mg (capsule shaped, white), and 400 mg (capsule shaped, yellow) tablets. Inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose 6cp, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone, sodium starch glycolate, talc, and titanium dioxide. In addition, the 25 mg contains iron oxide red and iron oxide yellow; the 100 mg, 150 mg, and 400 mg contains iron oxide yellow. The 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, and 400 mg tablets are printed with Opacode S-1-17823 black contains iron oxide black and shellac. Each 25 mg tablet contains 28.780 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.561 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.122 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.683 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.244 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.366 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.488 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine.

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 C42H50N6O4S2•C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is: [Structure] Quetiapine fumarate 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 equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.70 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.27 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.40 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.54 mg of quetiapine fumarate equivalent to 400 mg quetiapine. The USP dissolution test is pending.

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 C42H50N6O4S2•C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is: Structure Quetiapine fumarate 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 equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.70 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.27 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.40 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.54 mg of quetiapine fumarate equivalent to 400 mg quetiapine. The USP dissolution test is pending.

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 C42H50N6O4S2•C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is: [Structure] Quetiapine fumarate 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 equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.70 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.27 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.40 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.54 mg of quetiapine fumarate equivalent to 400 mg quetiapine. The USP dissolution test is pending.

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 42H 50N 6O 4S 2•C 4H 4O 4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is: [structural formula] 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 150 mg (white), 200 mg (yellow), 300 mg (light yellow), and 400 mg (white). All tablets are round shaped and film coated. Inactive ingredients for quetiapine extended-release tablets, USP are lactose monohydrate, sodium chloride, hydroxypropyl methylcellulose, povidone K30, talc and magnesium stearate. The film coating for all quetiapine extended-release tablets contain hypromellose, polyethylene glycol 400 and titanium dioxide. In addition, iron oxide yellow (200 and 300 mg tablets) is included in the film coating of specific strengths. Each 150 mg tablet contains 173 mg of quetiapine fumarate, USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230 mg of quetiapine fumarate, USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345 mg of quetiapine fumarate, USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 461 mg of quetiapine fumarate, USP equivalent to 400 mg quetiapine. Quetiapine Extended-release tablets, USP meet USP Dissolution Test 2.

Quetiapine USP 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 C42H50N6O4S2•C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is: [quetiapine-fig-1] 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 150 mg (white), 200 mg (yellow), 300 mg (pale yellow), and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients for quetiapine extended-release tablets are lactose monohydrate, microcrystalline cellulose, sodium citrate dihydrate, ethylcellulose, povidone, isopropyl alcohol and magnesium stearate. The film coating for all quetiapine extended-release tablets contain hypromellose, polyethylene glycol 400 and titanium dioxide. In addition, yellow iron oxide (200 and 300 mg tablets) are included in the film coating of specific strengths. 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. USP dissolution test is pending.

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 42H 50N 6O 4S 2•C 4H 4O 4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is: [structural formula] 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 150 mg (white), 200 mg (yellow), 300 mg (light yellow), and 400 mg (white). All tablets are round shaped and film coated. Inactive ingredients for quetiapine extended-release tablets, USP are lactose monohydrate, sodium chloride, hydroxypropyl methylcellulose, povidone K30, talc and magnesium stearate. The film coating for all quetiapine extended-release tablets contain hypromellose, polyethylene glycol 400 and titanium dioxide. In addition, iron oxide yellow (200 and 300 mg tablets) is included in the film coating of specific strengths. Each 150 mg tablet contains 173 mg of quetiapine fumarate, USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230 mg of quetiapine fumarate, USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345 mg of quetiapine fumarate, USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 461 mg of quetiapine fumarate, USP equivalent to 400 mg quetiapine. Quetiapine Extended-release tablets, USP meet USP Dissolution Test 2.

Quetiapine extended-release tablets are 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 42H 50N 6O 4S 2•C 4H 4O 4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is: [structural formula] Quetiapine fumarate, USP is a white to off-white crystalline powder which is soluble in 0.1N hydrochloric acid, slightly soluble in water, in alcohol, and in methanol. Quetiapine extended-release tablets,USP are supplied for oral administration as 50 mg (peach), 150 mg (white), 200 mg (yellow), 300 mg (pale yellow), and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients for quetiapine extended-release tablets are lactose monohydrate, microcrystalline cellulose, sodium citrate dihydrate, hypromellose, and magnesium stearate. The film coating for all quetiapine extended-release tablets, USP contain hypromellose, polyethylene glycol 400 and titanium dioxide. In addition, yellow iron oxide (50 mg, 200 mg and 300 mg tablets) and red iron oxide (50 mg tablets) are included in the film coating of specific strengths. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.7 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 460.5 mg of quetiapine fumarate equivalent to 400 mg quetiapine.

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 42H 50N 6O 4S 2•C 4H 4O 4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is: [structural formula] 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 150 mg (white), 200 mg (yellow), 300 mg (light yellow), and 400 mg (white). All tablets are round shaped and film coated. Inactive ingredients for quetiapine extended-release tablets, USP are lactose monohydrate, sodium chloride, hydroxypropyl methylcellulose, povidone K30, talc and magnesium stearate. The film coating for all quetiapine extended-release tablets contain hypromellose, polyethylene glycol 400 and titanium dioxide. In addition, iron oxide yellow (200 and 300 mg tablets) is included in the film coating of specific strengths. Each 150 mg tablet contains 173 mg of quetiapine fumarate, USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230 mg of quetiapine fumarate, USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345 mg of quetiapine fumarate, USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 461 mg of quetiapine fumarate, USP equivalent to 400 mg quetiapine. Quetiapine Extended-release tablets, USP meet USP Dissolution Test 2.

Quetiapine extended-release tablets are 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 42H 50N 6O 4S 2•C 4H 4O 4and it has a molecular weight of 883.11 (fumarate salt). The structural formula is: [structural formula] Quetiapine fumarate, USP is a white to off-white crystalline powder which is soluble in 0.1N hydrochloric acid, slightly soluble in water, in alcohol, and in methanol. Quetiapine extended-release tablets,USP are supplied for oral administration as 50 mg (peach), 150 mg (white), 200 mg (yellow), 300 mg (pale yellow), and 400 mg (white). All tablets are capsule shaped and film coated. Inactive ingredients for quetiapine extended-release tablets are lactose monohydrate, microcrystalline cellulose, sodium citrate dihydrate, hypromellose, and magnesium stearate. The film coating for all quetiapine extended-release tablets, USP contain hypromellose, polyethylene glycol 400 and titanium dioxide. In addition, yellow iron oxide (50 mg, 200 mg and 300 mg tablets) and red iron oxide (50 mg tablets) are included in the film coating of specific strengths. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 172.7 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 460.5 mg of quetiapine fumarate equivalent to 400 mg quetiapine. FDA approved dissolution test specifications differ from USP.

The active ingredient in rabeprazole sodium delayed-release tablets is rabeprazole sodium, which is a proton pump inhibitor. It is a substituted benzimidazole known chemically as 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfinyl]-1H–benzimidazole sodium salt. It has a molecular formula of C18H20N3NaO3S and a molecular weight of 381.42. Rabeprazole sodium is a white to off-white, hygroscopic powder. It is freely soluble in methanol and methylene chloride. The stability of rabeprazole sodium is a function of pH; it is rapidly degraded in acid media, and is more stable under alkaline conditions. The structural formula is: Figure 1 [Chemical Structure] Rabeprazole sodium is available for oral administration as delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium USP. Inactive ingredients of the 20 mg tablet are crospovidone, diacetylated monoglycerides, ethyl cellulose, ferric oxide yellow, hydroxypropyl cellulose, hypromellose phthalate, low substituted hydroxypropyl cellulose, magnesium stearate, mannitol, magnesium oxide, magnesium hydroxide, sodium carbonate, talc, and titanium dioxide. The tablets are printed with edible ink containing black iron oxide and shellac.

Ramelteon Tablets are 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 empirical formula of C 16H 21NO 2, molecular weight of 259.34, and the following chemical structure: [image description] Ramelteon is freely soluble in organic solvents, such as methanol, ethanol, and dimethyl sulfoxide; soluble in 1-octanol and acetonitrile; and very slightly soluble in water and in aqueous buffers from pH 3 to pH 11. Each Ramelteon Tablet includes the following inactive ingredients: lactose monohydrate, pregelatinized starch, hydroxypropyl cellulose, crospovidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc and iron oxide yellow.

Ramelteon is an orally active hypnotic chemically designated as (S)-N-[2-(1,6,7,8- tetrahydro-2H-indeno-[5,4-b]furan-8-yl)ethyl]propionamide and containing one chiral center. The compound is produced as the (S)-enantiomer, with an empirical formula of C16H21NO2, molecular weight of 259.34, and the following chemical structure: [Chemical Structure] Ramelteon is freely soluble in methanol and practically insoluble in water. Each ramelteon tablet contains the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide and yellow iron oxide.

Ramelteon is an orally active hypnotic chemically designated as (S)-N-[2-(1, 6, 7, 8 tetrahydro-2H-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 C16H21NO2, molecular weight of 259.34, and the following chemical structure: [Image] 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.

Risperidone tablets, USP contain risperidone USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2- benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is: [structure] Risperidone USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Risperidone tablets, USP are for oral administration and available in 0.25 mg (orange), 0.5 mg (orange), 1 mg (white), 2 mg (yellow), 3 mg (orange), and 4 mg (brown) strengths. Risperidone tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol (except 1 mg), sodium lauryl sulphate, sodium starch glycolate and polyethylene glycol (1 mg). Tablets of 0.25 mg, 0.5 mg, 2 mg, 3 mg, and 4 mg also contain talc and titanium dioxide. 0.25 mg, 0.5 mg, and 3 mg tablets contain FD&C Yellow # 6 aluminum lake, the 2 mg tablets contain yellow iron oxide; the 4 mg tablets contain iron oxide red.

Rizatriptan benzoate tablets contains rizatriptan benzoate USP, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is: [Structure] Its molecular formula is C15H19N5•C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate USP is a white to almost white, crystalline powder that is soluble in water and methanol, slightly soluble in isopropyl alcohol. Rizatriptan benzoate tablets are available for oral administration in strengths of 5 and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, maize starch, ferric oxide (red), and magnesium stearate.

Rizatriptan benzoate tablets USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H­-indole-3-ethanamine monobenzoate and its structural formula is: [Chemical Structure] Its molecular formula is C15H19N5•C7H6O2, representing a molecular weight of the free base of 269.35. Rizatriptan benzoate is a white to almost white crystalline powder that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate tablets USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: corn starch, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch (maize).

Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, USP a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is: [1] Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, ferric oxide (red), and magnesium stearate.

Rizatriptan benzoate tablet, USP contains rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is: [rizatriptan-Structure] Its empirical formula is C15H19N5•C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate Tablets, USP are available for oral administration in strengths of 5 and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize), and magnesium stearate.

Rizatriptan benzoate orally disintegrating tablets USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H­-indole-3-ethanamine monobenzoate and its structural formula is: Chemical Structure Its molecular formula is C15H19N5•C7H6O2, representing a molecular weight of the free base of 269.35. Rizatriptan benzoate is a white to almost white crystalline powder that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate orally disintegrating tablets USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each orally disintegrating tablet contains the following inactive ingredients: aspartame, crospovidone, mannitol, microcrystalline cellulose, peppermint, pregelatinized starch (maize), and sodium stearyl fumarate. Meets USP Dissolution Test 2.

Rizatriptan benzoate orally disintegrating tablets, USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D ) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is: [structure] Its molecular formula is C15H19N5•C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate orally disintegrating tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each orally disintegrating tablet contains following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, carboxymethyl cellulose calcium, magnesium stearate, mannitol, aspartame, and peppermint flavor. USP Dissolution Test 2.

Ropinirole tablets, USP contains ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the molecular formula is C 16H 24N 2O•HCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is: [chemical structure] Ropinirole hydrochloride is a white to yellow solid with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Each film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25, 0.5, 1, 2, 3, 4, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, and magnesium stearate, microcrystalline cellulose. The film coating of the tablet consists of following inactive ingredients: 0.25 mg: hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide. 0.5 mg: FD&C Blue #2/Indigo carmine aluminum lake, hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol and titanium dioxide. 1 mg: FD&C Blue #2/Indigo carmine aluminum lake, hypromellose, iron oxide yellow, polyethylene glycol and titanium dioxide. 2 mg: hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol and titanium dioxide. 3 mg: carmine, FD&C Blue #2/Indigo carmine aluminum lake, FD&C Yellow No. 6/Sunset yellow FCF aluminum lake, hypromellose, polyethylene glycol and titanium dioxide. 4 mg: hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol and titanium dioxide. 5 mg: FD&C Blue #2/Indigo carmine aluminum lake, hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide.

Ropinirole Tablets, USP contain ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2O•HCl. The molecular weight is 296.84 g/mol (260.38 as the free base). The structural formula is: [structure] Ropinirole hydrochloride, USP is a pale cream to yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Each circular, beveled edged, biconvex film-coated tablet contains ropinirole hydrochloride, USP equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of citric acid anhydrous powder, croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The ingredients of the film coating for each tablet are as follows: 0.25 mg: Hypromellose, polyethylene glycol, talc and titanium dioxide. 0.5 mg: FD&C Blue no. 2 aluminum lake, ferric oxide red, ferric oxide yellow, hypromellose, polyethylene glycol, talc and titanium dioxide. 1 mg: FD&C Blue no. 2 aluminum lake, ferric oxide black, ferric oxide yellow, hypromellose, polyethylene glycol, talc and titanium dioxide. 2 mg: Ferric oxide red, hypromellose, polyethylene glycol, talc and titanium dioxide. 3 mg: Carmine, FD&C Blue no. 2 aluminum lake, FD&C Yellow no. 6 aluminum lake, hypromellose, polyethylene glycol, talc and titanium dioxide. 4 mg: Ferric oxide black, ferric oxide red, ferric oxide yellow, hypromellose, polyethylene glycol, talc and titanium dioxide. 5 mg: FD&C Blue no. 1 aluminum lake, FD&C Blue no. 2 aluminum lake, hypromellose, polyethylene glycol, talc and titanium dioxide. The product meets USP Dissolution Test 2.

Ropinirole tablets, USP contains ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the molecular formula is C 16H 24N 2O•HCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is: [chemical structure] Ropinirole hydrochloride is a white to yellow solid with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Each film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25, 0.5, 1, 2, 3, 4, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, and magnesium stearate, microcrystalline cellulose. The film coating of the tablet consists of following inactive ingredients: 0.25 mg: hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide. 0.5 mg: FD&C Blue #2/Indigo carmine aluminum lake, hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol and titanium dioxide. 1 mg: FD&C Blue #2/Indigo carmine aluminum lake, hypromellose, iron oxide yellow, polyethylene glycol and titanium dioxide. 2 mg: hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol and titanium dioxide. 3 mg: carmine, FD&C Blue #2/Indigo carmine aluminum lake, FD&C Yellow No. 6/Sunset yellow FCF aluminum lake, hypromellose, polyethylene glycol and titanium dioxide. 4 mg: hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol and titanium dioxide. 5 mg: FD&C Blue #2/Indigo carmine aluminum lake, hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide.

Ropinirole tablets, USP contains ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C16H24N2O•HCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is: [molecular structure] Ropinirole hydrochloride, USP is a pale cream to yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Each modified oval shaped, biconvex film-coated tablet contains 0.29 mg, 0.57 mg, 1.14 mg, 2.28 mg, 3.42 mg, 4.56 mg, or 5.70 mg ropinirole hydrochloride, USP equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of microcrystalline cellulose, lactose monohydrate, citric acid monohydrate, croscarmellose sodium, magnesium stearate. 0.25 mg tablet contains opadry white. The components of opadry white are hypromellose, titanium dioxide, polyethylene glycol 6000 and polysorbate 80. 0.5 mg tablet contains opadry yellow. The components of opadry yellow are hypromellose, titanium dioxide, polyethylene glycol 6000, iron oxide yellow and polysorbate 80. 1 mg tablet contains opadry green. The components of opadry green are hypromellose, titanium dioxide, triacetin, iron oxide yellow and FD&C Blue No. 2. 2 mg tablet contains opadry pink. The components of opadry pink are hypromellose, titanium dioxide, polyethylene glycol 6000, iron oxide red and polysorbate 80. 3 mg tablet contains opadry purple. The components of opadry purple are hypromellose, titanium dioxide, carmine, polyethylene glycol 400, polysorbate 80 and FD&C Blue No. 1. 4 mg tablet contains opadry brown. The components of opadry brown are hypromellose, titanium dioxide, iron oxide red, polyethylene glycol 400, FD&C Blue No. 2, polysorbate 80 and iron oxide black. Also contains FD&C yellow No. 6 as a color additive. 5 mg tablet contains opadry blue. The components of opadry blue are hypromellose, titanium dioxide, polyethylene glycol 400, FD&C Blue No. 2 and polysorbate 80.

Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2•HCl is represented by the following structural formula: [Chemical Structure] Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets USP are supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3.

Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is: [Image] Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral use contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, citric acid, hydroxy propyl cellulose, hypromellose, iron oxides, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch, talc and titanium dioxide. Butylated hydroxyanisole is added as a preservative.

Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is: [Image] Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral use contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, citric acid, hydroxy propyl cellulose, hypromellose, iron oxides, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch, talc and titanium dioxide. Butylated hydroxyanisole is added as a preservative.

Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is: [Image] Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral use contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, citric acid, hydroxy propyl cellulose, hypromellose, iron oxides, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch, talc and titanium dioxide. Butylated hydroxyanisole is added as a preservative.

Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17­ hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula: [20] Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate, hypromellose, magnesium stearate, microcrystalline cellulose, N & A mint flavor, polyethylene glycol, polysorbate 80, povidone, pregelatinized corn starch, sodium starch glycolate, talc, and titanium dioxide

Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17­ hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula: [20] Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate, hypromellose, magnesium stearate, microcrystalline cellulose, N & A mint flavor, polyethylene glycol, polysorbate 80, povidone, pregelatinized corn starch, sodium starch glycolate, talc, and titanium dioxide

Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17­ hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula: [20] Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate, hypromellose, magnesium stearate, microcrystalline cellulose, N & A mint flavor, polyethylene glycol, polysorbate 80, povidone, pregelatinized corn starch, sodium starch glycolate, talc, and titanium dioxide

Sucralfate is an α-D-glucopyranoside, β-D-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. It has the following structural formula: [Sucralfate Tablets contain sucralfate and sucralfate is an α-D-glucopyranoside, β-D-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex.] Tablets for oral administration contain 1 g of sucralfate, USP. Also contain: povidone, magnesium stearate, and colloidal silicon dioxide. Therapeutic category: antiulcer.

Sucralfate, USP is an α-D-glucopyranoside, β-D-fructofuranosyl-, octakis(hydrogen sulfate), aluminum complex. [Structural formula for sucralfate] R = SO3Al(OH)2 Tablets for oral administration contain 1 g of sucralfate, USP and the following inactive ingredients: corn starch, magnesium stearate, and microcrystalline cellulose. Therapeutic Category antiulcer