Drugs Similar to MESALAMINE

MESALAMINE

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By Brand

Drugs with the same brand name or brand family

mesalamine MESALAMINE
ZYDUS LIFESCIENCES LIMITED FDA Rx Only

Summary not available yet.

MESALAMINE MESALAMINE
400 mg Delayed-release
GREENSTONE LLC FDA Rx Only

Each MESALAMINE delayed-release capsule for oral administration contains four 100 mg tablets of mesalamine, an aminosalicylate. MESALAMINE delayed-release capsules contain acrylic based resin, methacrylic acid and methyl methacrylate copolymer (Eudragit S), which dissolves at pH 7 or greater and releases mesalamine in the terminal ileum and beyond for topical anti-inflammatory action in the colon. Mesalamine (also referred to as 5-aminosalicylic acid or 5-ASA) has the chemical name 5-amino-2-hydroxybenzoic acid. Its structural formula is: Inactive Ingredients : Each capsule contains colloidal silicon dioxide, dibutyl sebacate, ferric oxide red (3.44 mg), ferric oxide yellow (0.62 mg), lactose monohydrate, magnesium stearate, methacrylic acid and methyl methancrylate copolymer (Eudragit S), polyethylene glycol, povidone, sodium starch glycolate, talc and hydroxypropyl methylcellulose (HPMC). The structural formula for MESALAMINE delayed-release capsule for oral administration contains four 100 mg tablets of mesalamine, an aminosalicylate. MESALAMINE delayed-release capsules contain acrylic based resin, methacrylic acid and methyl methacrylate copolymer (Eudragit S), which dissolves at pH 7 or greater and releases mesalamine in the terminal ileum and beyond for topical anti-inflammatory action in the colon. Mesalamine (also referred to as 5-aminosalicylic acid or 5-ASA) has the chemical name 5-amino-2-hydroxybenzoic acid.

MESALAMINE MESALAMINE
1.2 g Delayed-release
LANNETT COMPANY INC. FDA Rx Only

Each mesalamine delayed-release tablet, USP for oral administration contains 1.2 g 5-aminosalicylic acid (5-ASA; mesalamine), an anti-inflammatory agent. Mesalamine, USP also has the chemical name 5-amino-2-hydroxybenzoic acid and its structural formula is: Molecular formula:C 7 H 7 NO 3 Molecular weight:153.14 The tablet is coated with a pH-dependent polymer film, which breaks down at or above pH 6.8, normally in the terminal ileum where mesalamine, USP then begins to be released from the tablet core. The tablet core contains mesalamine with hydrophilic and lipophilic excipients and provides for extended release of mesalamine. The inactive ingredients of mesalamine delayed-release tablets, USP are colloidal silicon dioxide, magnesium stearate, carboxymethylcellulose sodium, sodium starch glycolate, hypromellose, microcrystalline cellulose, methacrylic acid-methyl methacrylate copolymer 1:1, methacrylic acid-methyl methacrylate copolymer 1:2, triethyl citrate, talc, polyvinyl alcohol, titanium dioxide, macrogol/PEG, iron oxide red and iron oxide yellow. FDA approved dissolution test specifications differ from USP. structure

MESALAMINE MESALAMINE
0.375 g Extended-release
CAMBER PHARMACEUTICALS, INC. FDA Rx Only

Each mesalamine extended-release capsule, USP is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine, USP (5-aminosalicylic acid, 5-ASA), an aminosalicylate. The structural formula of mesalamine, USP is: Molecular Weight: 153.14 Molecular Formula: C 7 H 7 NO 3 Each mesalamine extended-release capsule, USP contains pellets composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above. The inactive ingredients of mesalamine extended-release capsules, USP are: colloidal silicon dioxide, ethyl acrylate and methyl methacrylate copolymer dispersion, hypromellose, magnesium stearate, methacrylic acid and methyl methacrylate copolymer (1:1), microcrystalline cellulose, simethicone emulsion 30%, talc, titanium dioxide and triethyl citrate. The capsule shell contains gelatin, iron oxide red, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. The capsule shells are imprinted with edible black ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. FDA approved dissolution test specifications differ from USP. mesalaminestructure

Mesalamine MESALAMINE
1.2 g Delayed-release
CHARTWELL RX, LLC FDA Rx Only

Each Mesalamine Delayed-Release Tablet, USP for oral administration contains 1.2 g 5-aminosalicylic acid (5-ASA; mesalamine), an anti-inflammatory agent. Mesalamine also has the chemical name 5-amino-2-hydroxybenzoic acid and its structural formula is: Molecular formula: C 7 H 7 NO 3 Molecular weight: 153.14 The tablet is coated with a pH-dependent polymer film, which breaks down at or above pH 6.8, normally in the terminal ileum where mesalamine then begins to be released from the tablet core. The tablet core contains mesalamine with hydrophilic and lipophilic excipients and provides for extended release of mesalamine. The inactive ingredients of Mesalamine Delayed-Release Tablets, USP are colloidal silicon dioxide, magnesium stearate, carboxymethylcellulose sodium, sodium starch glycolate, hypromellose, microcrystalline cellulose, methacrylic acid-methyl methacrylate copolymer 1:1, methacrylic acid-methyl methacrylate copolymer 1:2, triethyl citrate, talc, polyvinyl alcohol, titanium dioxide, macrogol/PEG, iron oxide red and iron oxide yellow. FDA approved dissolution test specifications differ from USP. image description

Mesalamine MESALAMINE
BRYANT RANCH PREPACK FDA Rx Only

The active ingredient in Mesalamine Rectal Suspension, USP Enema, a disposable (60 mL) unit, is mesalamine, also known as 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid. The empirical formula is C 7 H 7 NO 3 , representing a molecular weight of 153.14. The structural formula is: Each rectal suspension enema unit contains 4 grams of mesalamine. In addition to mesalamine the preparation contains the inactive ingredients carbomer 934P, edetate disodium, potassium acetate, potassium metabisulfite, purified water and xanthan gum. Sodium benzoate is added as a preservative. The disposable unit consists of an applicator tip protected by a polyethylene cover and lubricated with USP white petrolatum. The unit has a one-way valve to prevent back flow of the dispensed product.

MESALAMINE MESALAMINE
0.375 g Extended-release
ALEMBIC PHARMACEUTICALS LIMITED FDA Rx Only

Each mesalamine capsule is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine, USP (5-aminosalicylic acid, 5-ASA), an aminosalicylate. The structural formula of mesalamine is: Molecular Weight: 153.14 Molecular Formula: C 7 H 7 NO 3 Each mesalamine extended-release capsule contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above. The inactive ingredients of mesalamine extended-release capsules are: microcrystalline cellulose, hypromellose, colloidal silicon dioxide, ethyl acrylate and methyl methacrylate 2:1 copolymer, magnesium stearate, methacrylic acid and methyl methacrylate 1:1 copolymer, talc, triethyl citrate, titanium dioxide and hypromellose phthalate. The capsule shell contains titanium dioxide, FD&C Blue 1, FD&C Red 40 and gelatin. The capsule shells are printed with edible black ink containing shellac, black iron oxide and potassium hydroxide. FDA approved dissolution test specifications differ from USP. structure

Mesalamine MESALAMINE
ZYDUS LIFESCIENCES LIMITED FDA Rx Only

Summary not available yet.

Mesalamine MESALAMINE
100 mg Delayed-release
TEVA PHARMACEUTICALS USA, INC. FDA Rx Only

Each Mesalamine delayed-release capsule for oral administration contains four 100 mg tablets of mesalamine, USP an aminosalicylate. Mesalamine delayed-release capsules contain acrylic based resin, methacrylic acid copolymer (Eudragit S), which dissolves at pH 7 or greater and releases mesalamine in the terminal ileum and beyond for topical anti-inflammatory action in the colon. Mesalamine, USP (also referred to as 5-aminosalicylic acid or 5-ASA) has the chemical name 5-amino-2-hydroxybenzoic acid. Its structural formula is: C 7 H 7 NO 3 M.W. 153.14 Inactive Ingredients: Each capsule contains colloidal silicon dioxide, dibutyl sebacate, hypromellose, iron oxide black, iron oxide red, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, potassium hydroxide, povidone, propylene glycol, shellac, sodium starch glycolate (potato), strong ammonia solution and talc. 1

Mesalamine MESALAMINE
1000 mg Suppository
ACTAVIS PHARMA, INC. FDA Rx Only

The active ingredient in mesalamine 1000 mg suppositories for rectal use is mesalamine USP, also known as mesalazine or 5-aminosalicylic acid (5-ASA). Chemically, mesalamine, USP is 5-amino-2-hydroxybenzoic acid, and is classified as an aminosalicylate. Each mesalamine rectal suppository contains 1000 mg of mesalamine, USP in a base of hard fat base. The molecular formula is C 7 H 7 NO 3 , representing a molecular weight of 153.14. The structural formula is: 1

Mesalamine MESALAMINE
0.375 g Extended-release
ASCEND LABORATORIES, LLC FDA Rx Only

Each mesalamine extended-release capsule is a delayed-and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine USP (5-aminosalicylic acid, 5-ASA), an aminosalicylate. The structural formula of mesalamine is: Molecular Weight: 153.14 Molecular Formula: C 7 H 7 NO 3 Each mesalamine extended-release capsules, USP contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above. The inactive ingredients of mesalamine extended-release capsules USP are black iron oxide, colloidal silicon dioxide, edible black ink which contains shellac, ethyl acrylate and methyl methacrylate copolymer, FD and C Blue # 1, FD and C Red # 3, gelatin, hypromellose, magnesium stearate, methacrylic acid and methyl methacrylate copolymer, microcrystalline cellulose, polyethylene glycol, potassium hydroxide, propylene glycol, sodium lauryl sulphate, talc, titanium dioxide, triethyl citrate, vanillin. FDA approved dissolution test specifications differ from USP acceptance criteria mesalamine-structure

Mesalamine MESALAMINE
0.375 g Extended-release
INGENUS PHARMACEUTICALS, LLC FDA Rx Only

Each mesalamine extended-release capsule, USP is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine USP (5-aminosalicylic acid, 5-ASA), an aminosalicylate. The structural formula of mesalamine is: Molecular Weight: 153.14 Molecular Formula: C 7 H 7 NO 3 Each mesalamine extended-release capsule, USP contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above. The inactive ingredients of mesalamine extended-release capsules, USP are: microcrystalline cellulose, ethyl cellulose, hypromellose, methacrylic acid and methyl methacrylate copolymer (1:1), triethyl citrate, talc, gelatin, FD&C Blue 2, titanium dioxide, shellac, potassium hydroxide and black iron oxide. FDA approved dissolution test specifications differ from the USP. Mesalamine Structural Formula

Mesalamine MESALAMINE
800 mg Delayed-release
AMERICAN HEALTH PACKAGING FDA Rx Only

Each mesalamine delayed-release tablet for oral administration contains 800 mg of mesalamine USP, an aminosalicylate. Mesalamine, USP is light tan to pink colored, needle-shaped crystals. Color may darken on exposure to air. It is odorless or may have a slight characteristic odor, slightly soluble in water; very slightly soluble in methanol, in dehydrated alcohol, and in acetone; practically insoluble in n -butyl alcohol, in chloroform, in ether, in ethyl acetate, in n -hexane, in methylene chloride, and in n -propyl alcohol and soluble in dilute hydrochloric acid and in dilute alkali hydroxides. Mesalamine delayed-release tablets 800 mg have single layered coating consisting of an acrylic based resin Eudragit S (methacrylic acid copolymer B, NF), which dissolves at pH 7 or greater, releasing mesalamine for topical anti-inflammatory action in the colon. Mesalamine (also referred to as 5-aminosalicylic acid or 5-ASA) has the chemical name 5-amino-2-hydroxybenzoic acid and its structural formula is: Each mesalamine delayed-release tablet contains 800 mg of mesalamine. In addition, each tablet contains the following inactive ingredients: acetyltributyl citrate, colloidal silicone dioxide, ferric oxide red, magnesium stearate, methacrylic acid copolymer type B, microcrystalline cellulose, povidone, sodium starch glycolate, talc and titanium dioxide. The tablet is printed with opacode black S-1-17823 which contains following ingredients: ammonium hydroxide, butyl alcohol, ferrosoferric oxide, isopropyl alcohol, propylene glycol and shellac. Structural Formula

Mesalamine MESALAMINE
1.2 g Delayed-release
CAMBER PHARMACEUTICALS, INC. FDA Rx Only

Each mesalamine delayed-release tablet, USP for oral administration contains 1.2 g 5-aminosalicylic acid (5-ASA; mesalamine), an anti-inflammatory agent. Mesalamine also has the chemical name 5-amino-2-hydroxybenzoic acid and its structural formula is: Molecular formula: C 7 H 7 NO 3 Molecular weight: 153.14 The tablet is coated with a pH-dependent polymer film, which breaks down at or above pH 6.8, normally in the terminal ileum where mesalamine then begins to be released from the tablet core. The tablet core contains mesalamine with hydrophilic and lipophilic excipients and provides for extended release of mesalamine. The inactive ingredients of mesalamine delayed-release tablets, USP are colloidal silicon dioxide, ferric oxide, hypromellose, magnesium stearate, methacrylic acid and methyl methacrylate copolymer, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc, titanium dioxide, triethyl citrate, the imprinting ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac. FDA approved dissolution test specifications differ from USP. mesalaminedrtabsstructure

mesalamine MESALAMINE
1.2 g Delayed-release
MAJOR PHARMACEUTICALS FDA Rx Only

Each mesalamine delayed-release tablet for oral administration contains 1.2 g 5-aminosalicylic acid (5-ASA; mesalamine), an anti-inflammatory agent. Mesalamine also has the chemical name 5-amino-2-hydroxybenzoic acid and its structural formula is: Molecular formula: C 7 H 7 NO 3 Molecular weight: 153.14 Mesalamine, USP is a light tan to pink colored, needle-shaped crystals. Color may darken on exposure to air. It is odorless or may have a slight characteristic odor. The tablet is coated with a pH-dependent polymer film, which breaks down at or above pH 6.8, normally in the terminal ileum where mesalamine then begins to be released from the tablet core . The tablet core contains mesalamine with hydrophilic excipients and provides for extended release of mesalamine. Each mesalamine delayed-release tablet, USP intended for oral administration contains 1.2 g of mesalamine. In addition, each tablet contains the following inactive ingredients: carboxymethylcellulose sodium, colloidal silicon dioxide, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, triethyl citrate, talc and titanium dioxide. The Product meets USP Dissolution Test 4. Image

mesalamine MESALAMINE
1.2 g Delayed-release
ZYDUS PHARMACEUTICALS USA INC. FDA Rx Only

Each mesalamine delayed-release tablet for oral administration contains 1.2 g 5-aminosalicylic acid (5-ASA; mesalamine), an anti-inflammatory agent. Mesalamine also has the chemical name 5-amino-2-hydroxybenzoic acid and its structural formula is: Molecular formula: C 7 H 7 NO 3 Molecular weight: 153.14 Mesalamine, USP is a light tan to pink colored, needle-shaped crystals. Color may darken on exposure to air. It is odorless or may have a slight characteristic odor. The tablet is coated with a pH-dependent polymer film, which breaks down at or above pH 6.8, normally in the terminal ileum where mesalamine then begins to be released from the tablet core . The tablet core contains mesalamine with hydrophilic excipients and provides for extended release of mesalamine. Each mesalamine delayed-release tablet, USP intended for oral administration contains 1.2 g of mesalamine. In addition, each tablet contains the following inactive ingredients: carboxymethylcellulose sodium, colloidal silicon dioxide, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, triethyl citrate, talc and titanium dioxide. The Product meets USP Dissolution Test 4. Image

Mesalamine MESALAMINE
0.375 g Extended-release
UPSHER-SMITH LABORATORIES, LLC FDA Rx Only

Each Mesalamine Extended-Release Capsule, USP is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine USP (5-aminosalicylic acid, 5-ASA), an aminosalicylate. The structural formula of mesalamine is: Molecular Weight: 153.14 Molecular Formula: C 7 H 7 NO 3 Each Mesalamine Extended-Release Capsule, USP contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above. The inactive ingredients of Mesalamine Extended-Release Capsules, USP are: ethylcellulose, FD&C Blue No. 1, gelatin, hypromellose, methacrylic acid and methyl methacrylate copolymer, silicon dioxide, sodium lauryl sulfate, sugar spheres (corn starch and sucrose), talc, titanium dioxide and triethyl citrate. The imprinting ink has the following ingredients: ferrosoferric oxide, potassium hydroxide and shellac. FDA approved dissolution test specifications differ from USP. Chemical Structure

Mesalamine MESALAMINE
ZYDUS LIFESCIENCES LIMITED FDA Rx Only

Summary not available yet.

Mesalamine MESALAMINE
1000 mg Suppository
NORTHSTAR RX LLC. FDA Rx Only

The active ingredient in Mesalamine suppositories, USP 1000 mg is mesalamine, also known as mesalazine or 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid, and is classified as an aminosalicylate. Each mesalamine suppository,USP contains 1000 mg of mesalamine, USP (micronized) in a base of hard fat. Mesalamine, USP (micronized) are light tan to pink colored, needle-shaped crystals. Color may darken on exposure to air. It is odorless or may have a slight characteristic odor. It is slightly soluble in water; very slightly soluble in methanol, in dehydrated alcohol, and in acetone; practically insoluble in n-butyl alcohol, in chloroform, in ether, in ethyl acetate, in n-hexane, in methylene chloride, and in n-propyl alcohol; soluble in dilute hydrochloric acid and in dilute alkali hydroxides. The molecular formula is C 7 H 7 NO 3 , representing a molecular weight of 153.14. The structural formula is: Mesalamine rectal suppository

Mesalamine MESALAMINE
1.2 g Delayed-release
ACTAVIS PHARMA, INC. FDA Rx Only

Each mesalamine delayed-release tablet, USP for oral administration contains 1.2 g 5-aminosalicylic acid (5-ASA; mesalamine, USP), an anti-inflammatory agent. Mesalamine, USP also has the chemical name 5-amino-2-hydroxybenzoic acid and its structural formula is: The tablet is coated with a pH-dependent polymer film, which breaks down at or above pH 6.8, normally in the terminal ileum where mesalamine, USP then begins to be released from the tablet core . The inactive ingredients of mesalamine delayed-release tablets, USP are ammonium hydroxide, colloidal silicon dioxide, copovidone, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, methacrylic acid and methyl methacrylate copolymer, microcrystalline cellulose, polyethylene glycol 3350, polyvinyl alcohol, povidone, propylene glycol, shellac, sodium starch glycolate (type A), talc, titanium dioxide and triethyl citrate. Meets USP Dissolution Test 3. Chemical Structure

By Generic Name

Drugs with the same generic name (different brands)

APRISO MESALAMINE
(MESALAMINE) 0.375 g Extended-release
SALIX PHARMACEUTICALS, INC. FDA Rx Only

Each APRISO ® capsule is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine USP (5-aminosalicylic acid, 5-ASA), an aminosalicylate. The structural formula of mesalamine is: Molecular Weight: 153.14 Molecular Formula: C 7 H 7 NO 3 Each APRISO capsule contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above. The inactive ingredients of APRISO capsules are: anhydrous citric acid, aspartame, colloidal silicon dioxide, edible black ink, hypromellose, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, simethicone emulsion, ethyl acrylate/methyl methacrylate copolymer, talc, titanium dioxide, triethyl citrate, vanilla flavor. Each APRISO 0.375 g capsule contains 0.56 mg of phenylalanine. Chemical Structure

Canasa MESALAMINE
(MESALAMINE) 1000 mg Suppository
ALLERGAN, INC. FDA Rx Only

The active ingredient in CANASA 1000 mg suppositories for rectal use is mesalamine, also known as mesalazine or 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid, and is classified as an aminosalicylate. Each CANASA rectal suppository contains 1000 mg of mesalamine (USP) in a base of Hard Fat, NF. The empirical formula is C 7 H 7 NO 3 , representing a molecular weight of 153.14. The structural formula is: The structural formula for C7H7NO3, representing a molecular weight of 153.14.

Lialda MESALAMINE
(MESALAMINE) 1.2 g Delayed-release
TAKEDA PHARMACEUTICALS AMERICA, INC. FDA Rx Only

Each LIALDA delayed-release tablet for oral administration contains 1.2 g 5-aminosalicylic acid (5-ASA; mesalamine), an anti-inflammatory agent. Mesalamine also has the chemical name 5-amino-2-hydroxybenzoic acid and its structural formula is: Molecular formula: C 7 H 7 NO 3 Molecular weight: 153.14 The tablet is coated with a pH-dependent polymer film, which breaks down at or above pH 6.8, normally in the terminal ileum where mesalamine then begins to be released from the tablet core. The tablet core contains mesalamine with hydrophilic and lipophilic excipients and provides for extended release of mesalamine. The inactive ingredients of LIALDA are sodium carboxymethylcellulose, carnauba wax, stearic acid, silica (colloidal hydrated), sodium starch glycolate (type A), talc, magnesium stearate, methacrylic acid copolymer types A and B, triethylcitrate, titanium dioxide, red ferric oxide, and polyethylene glycol 6000. Chemical Structure

Mesalamine MESALAMINE
ANI PHARMACEUTICALS, INC. FDA Rx Only

The active ingredient in Mesalamine Rectal Suspension Enema, a disposable (60 mL) unit, is mesalamine, also known as 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid. The empirical formula is C 7 H 7 NO 3 , representing a molecular weight of 153.14. The structural formula is: Each rectal suspension enema unit contains 4 grams of mesalamine. In addition to mesalamine the preparation contains the inactive ingredients carbomer 934P, edetate disodium, potassium acetate, potassium metabisulfite, purified water and xanthan gum. Sodium benzoate is added as a preservative. The disposable unit consists of an applicator tip protected by a polyethylene cover and lubricated with USP white petrolatum. The unit has a one-way valve to prevent back flow of the dispensed product. structure

MESALAMINE MESALAMINE
0.375 g Extended-release
ALEMBIC PHARMACEUTICALS INC. FDA Rx Only

Each mesalamine capsule is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine, USP (5-aminosalicylic acid, 5-ASA), an aminosalicylate. The structural formula of mesalamine is: Molecular Weight: 153.14 Molecular Formula: C 7 H 7 NO 3 Each mesalamine extended-release capsule contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above. The inactive ingredients of mesalamine extended-release capsules are: microcrystalline cellulose, hypromellose, colloidal silicon dioxide, ethyl acrylate and methyl methacrylate 2:1 copolymer, magnesium stearate, methacrylic acid and methyl methacrylate 1:1 copolymer, talc, triethyl citrate, titanium dioxide and hypromellose phthalate. The capsule shell contains titanium dioxide, FD&C Blue 1, FD&C Red 40 and gelatin. The capsule shells are printed with edible black ink containing shellac, black iron oxide and potassium hydroxide. Meets USP Dissolution Test 5. structure

Mesalamine MESALAMINE
100 mg Delayed-release
AMERICAN HEALTH PACKAGING FDA Rx Only

Each Mesalamine delayed-release capsule for oral administration contains four 100 mg tablets of mesalamine, an aminosalicylate. Mesalamine delayed-release capsules contain acrylic based resin, methacrylic acid copolymer (Eudragit S), which dissolves at pH 7 or greater and releases mesalamine in the terminal ileum and beyond for topical anti-inflammatory action in the colon. Mesalamine, USP (also referred to as 5-aminosalicylic acid or 5-ASA) has the chemical name 5-amino-2-hydroxybenzoic acid. Its structural formula is: C 7 H 7 NO 3 M.W. 153.14 Inactive Ingredients: Each capsule contains colloidal silicon dioxide, dibutyl sebacate, hypromellose, iron oxide black, iron oxide red, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, potassium hydroxide, povidone, propylene glycol, shellac, sodium starch glycolate (potato), and talc. Structural formula

Mesalamine MESALAMINE
4 g/60 ml Suspension
ENCUBE ETHICALS, INC. FDA Rx Only

The active ingredient in mesalamine rectal suspension, USP enema, a disposable (60 mL) unit, is mesalamine, also known as 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid. The empirical formula is C 7 H 7 NO 3 , representing a molecular weight of 153.14. The structural formula is: Mesalamine rectal suspension, USP enema is supplied as a suspension for rectal administration. Each rectal suspension enema unit contains 4 grams of mesalamine. The inactive ingredients are carbomer 934P, edetate disodium, potassium acetate, potassium metabisulfite, purified water and xanthan gum. Sodium benzoate is added as a preservative. The disposable unit consists of an applicator tip protected by a polyethylene cover and lubricated with USP white petrolatum. The unit has a one-way valve to prevent back flow of the dispensed product. str

Mesalamine MESALAMINE
1000 mg Suppository
ZYDUS PHARMACEUTICALS USA INC. FDA Rx Only

The active ingredient in Mesalamine suppositories, USP 1000 mg is mesalamine, also known as mesalazine or 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid, and is classified as an aminosalicylate. Each Mesalamine suppository, USP contains 1000 mg of mesalamine, USP (micronized) in a base of hard fat. Mesalamine, USP (micronized) are light tan to pink colored, needle-shaped crystals. Color may darken on exposure to air. It is odorless or may have a slight characteristic odor. It is slightly soluble in water; very slightly soluble in methanol, in dehydrated alcohol, and in acetone; practically insoluble in n-butyl alcohol, in chloroform, in ether, in ethyl acetate, in n-hexane, in methylene chloride, and in n-propyl alcohol; soluble in dilute hydrochloric acid and in dilute alkali hydroxides. The molecular formula is C 7 H 7 NO 3 , representing a molecular weight of 153.14. The structural formula is: Mesalamine rectal suppository

Mesalamine MESALAMINE
ZYDUS LIFESCIENCES LIMITED FDA Rx Only

Summary not available yet.

Mesalamine MESALAMINE
1000 mg Suppository
ACTAVIS PHARMA, INC. FDA Rx Only

The active ingredient in mesalamine 1000 mg suppositories for rectal use is mesalamine USP, also known as mesalazine or 5-aminosalicylic acid (5-ASA). Chemically, mesalamine, USP is 5-amino-2-hydroxybenzoic acid, and is classified as an aminosalicylate. Each mesalamine rectal suppository contains 1000 mg of mesalamine, USP in a base of hard fat base. The molecular formula is C 7 H 7 NO 3 , representing a molecular weight of 153.14. The structural formula is: 1

Mesalamine MESALAMINE
0.375 g Extended-release
ASCEND LABORATORIES, LLC FDA Rx Only

Each mesalamine extended-release capsule is a delayed-and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine USP (5-aminosalicylic acid, 5-ASA), an aminosalicylate. The structural formula of mesalamine is: Molecular Weight: 153.14 Molecular Formula: C 7 H 7 NO 3 Each mesalamine extended-release capsules, USP contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above. The inactive ingredients of mesalamine extended-release capsules USP are black iron oxide, colloidal silicon dioxide, edible black ink which contains shellac, ethyl acrylate and methyl methacrylate copolymer, FD and C Blue # 1, FD and C Red # 3, gelatin, hypromellose, magnesium stearate, methacrylic acid and methyl methacrylate copolymer, microcrystalline cellulose, polyethylene glycol, potassium hydroxide, propylene glycol, sodium lauryl sulphate, talc, titanium dioxide, triethyl citrate, vanillin. FDA approved dissolution test specifications differ from USP acceptance criteria mesalamine-structure

Mesalamine MESALAMINE
4 g/60 ml Suspension
PADAGIS ISRAEL PHARMACEUTICALS LTD FDA Rx Only

The active ingredient in Mesalamine Rectal Suspension, USP Enema, a disposable (60 mL) unit, is mesalamine, also known as 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid. The empirical formula is C 7 H 7 NO 3 , representing a molecular weight of 153.14. The structural formula is: Mesalamine rectal suspension enema is supplied as a suspension for rectal administration. Each rectal suspension enema unit contains 4 grams of mesalamine. The inactive ingredients are carbomer 974P, edetate disodium, potassium acetate, potassium metabisulfite, purified water and xanthan gum. Sodium benzoate is added as a preservative. The disposable unit consists of an applicator tip protected by a polyethylene cover and lubricated with USP white petrolatum. The unit has a one-way valve to prevent back flow of the dispensed product. Structural Formula Image

Mesalamine MESALAMINE
800 mg Delayed-release
AMERICAN HEALTH PACKAGING FDA Rx Only

Each mesalamine delayed-release tablet for oral administration contains 800 mg of mesalamine USP, an aminosalicylate. Mesalamine, USP is light tan to pink colored, needle-shaped crystals. Color may darken on exposure to air. It is odorless or may have a slight characteristic odor, slightly soluble in water; very slightly soluble in methanol, in dehydrated alcohol, and in acetone; practically insoluble in n -butyl alcohol, in chloroform, in ether, in ethyl acetate, in n -hexane, in methylene chloride, and in n -propyl alcohol and soluble in dilute hydrochloric acid and in dilute alkali hydroxides. Mesalamine delayed-release tablets 800 mg have single layered coating consisting of an acrylic based resin Eudragit S (methacrylic acid copolymer B, NF), which dissolves at pH 7 or greater, releasing mesalamine for topical anti-inflammatory action in the colon. Mesalamine (also referred to as 5-aminosalicylic acid or 5-ASA) has the chemical name 5-amino-2-hydroxybenzoic acid and its structural formula is: Each mesalamine delayed-release tablet contains 800 mg of mesalamine. In addition, each tablet contains the following inactive ingredients: acetyltributyl citrate, colloidal silicone dioxide, ferric oxide red, magnesium stearate, methacrylic acid copolymer type B, microcrystalline cellulose, povidone, sodium starch glycolate, talc and titanium dioxide. The tablet is printed with opacode black S-1-17823 which contains following ingredients: ammonium hydroxide, butyl alcohol, ferrosoferric oxide, isopropyl alcohol, propylene glycol and shellac. Structural Formula

Mesalamine MESALAMINE
1000 mg Suppository
BRYANT RANCH PREPACK FDA Rx Only

The active ingredient in mesalamine suppositories 1000 mg for rectal use is mesalamine, also known as mesalazine or 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid, and is classified as an anti-inflammatory drug. Each mesalamine suppository contains 1000 mg of mesalamine (USP) in a base of Hard Fat, NF. The empirical formula is C 7 H 7 NO 3 , representing a molecular weight of 153.14. The structural formula is:

Mesalamine MESALAMINE
1.2 g Delayed-release
NORTHSTAR RXLLC FDA Rx Only

Each mesalamine delayed-release tablet, USP for oral administration contains 1.2 g 5-aminosalicylic acid (5-ASA; mesalamine), an anti-inflammatory agent. Mesalamine also has the chemical name 5-amino-2-hydroxybenzoic acid and its structural formula is: Molecular formula: C 7 H 7 NO 3 Molecular weight: 153.14 The tablet is coated with a pH-dependent polymer film, which breaks down at or above pH 6.8, normally in the terminal ileum where mesalamine then begins to be released from the tablet core. The tablet core contains mesalamine with hydrophilic and lipophilic excipients and provides for extended release of mesalamine. The inactive ingredients of mesalamine delayed-release tablets, USP are colloidal silicon dioxide, ferric oxide, hypromellose, magnesium stearate, methacrylic acid and methyl methacrylate copolymer, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc, titanium dioxide, triethyl citrate, the imprinting ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac. FDA approved dissolution test specifications differ from USP. mesalaminedrtabsstructure

Mesalamine MESALAMINE
BRYANT RANCH PREPACK FDA Rx Only

The active ingredient in Mesalamine Rectal Suspension, USP Enema, a disposable (60 mL) unit, is mesalamine, also known as 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid. The empirical formula is C 7 H 7 NO 3 , representing a molecular weight of 153.14. The structural formula is: Each rectal suspension enema unit contains 4 grams of mesalamine. In addition to mesalamine the preparation contains the inactive ingredients carbomer 934P, edetate disodium, potassium acetate, potassium metabisulfite, purified water and xanthan gum. Sodium benzoate is added as a preservative. The disposable unit consists of an applicator tip protected by a polyethylene cover and lubricated with USP white petrolatum. The unit has a one-way valve to prevent back flow of the dispensed product.

mesalamine MESALAMINE
ZYDUS LIFESCIENCES LIMITED FDA Rx Only

Summary not available yet.

MESALAMINE MESALAMINE
400 mg Delayed-release
GREENSTONE LLC FDA Rx Only

Each MESALAMINE delayed-release capsule for oral administration contains four 100 mg tablets of mesalamine, an aminosalicylate. MESALAMINE delayed-release capsules contain acrylic based resin, methacrylic acid and methyl methacrylate copolymer (Eudragit S), which dissolves at pH 7 or greater and releases mesalamine in the terminal ileum and beyond for topical anti-inflammatory action in the colon. Mesalamine (also referred to as 5-aminosalicylic acid or 5-ASA) has the chemical name 5-amino-2-hydroxybenzoic acid. Its structural formula is: Inactive Ingredients : Each capsule contains colloidal silicon dioxide, dibutyl sebacate, ferric oxide red (3.44 mg), ferric oxide yellow (0.62 mg), lactose monohydrate, magnesium stearate, methacrylic acid and methyl methancrylate copolymer (Eudragit S), polyethylene glycol, povidone, sodium starch glycolate, talc and hydroxypropyl methylcellulose (HPMC). The structural formula for MESALAMINE delayed-release capsule for oral administration contains four 100 mg tablets of mesalamine, an aminosalicylate. MESALAMINE delayed-release capsules contain acrylic based resin, methacrylic acid and methyl methacrylate copolymer (Eudragit S), which dissolves at pH 7 or greater and releases mesalamine in the terminal ileum and beyond for topical anti-inflammatory action in the colon. Mesalamine (also referred to as 5-aminosalicylic acid or 5-ASA) has the chemical name 5-amino-2-hydroxybenzoic acid.

Mesalamine MESALAMINE
800 mg Delayed-release
TEVA PHARMACEUTICALS, INC. FDA Rx Only

Each mesalamine delayed-release tablet, USP for oral administration contains 800 mg of mesalamine, USP, an aminosalicylate. Mesalamine delayed-release tablets, USP have an outer protective coat consisting of a combination of acrylic based resins, methacrylic acid and methyl methacrylate copolymer (1:2) and methacrylic acid and methyl methacrylate copolymer (1:1). The inner coat consists of an acrylic based resin, methacrylic acid and methyl methacrylate copolymer (1:2), which dissolves at pH 7 or greater, releasing mesalamine in the terminal ileum and beyond for topical anti-inflammatory action in the colon. Mesalamine, USP (also referred to as 5-aminosalicylic acid or 5-ASA) has the chemical name 5-amino-2-hydroxybenzoic acid; its structural formula is: Molecular Weight: 153.1 Molecular Formula: C 7 H 7 NO 3 Inactive Ingredients: Each tablet contains colloidal silicon dioxide, dibutyl sebacate, FD&C Red #40/Allura Red AC Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, iron oxide red, lactose monohydrate, magnesium stearate, methacrylic acid and methyl methacrylate copolymer (1:1), methacrylic acid and methyl methacrylate copolymer (1:2), polyethylene glycol 3350, polyethylene glycol 6000, polyvinyl alcohol, povidone K-30, sodium starch glycolate (type A), talc, and titanium dioxide. In addition the imprinting white ink contains isopropyl alcohol, n-butyl alcohol, propylene glycol, and shellac glaze. 1

Mesalamine MESALAMINE
BRYANT RANCH PREPACK FDA Rx Only

The active ingredient in Mesalamine Rectal Suspension, USP Enema, a disposable (60 mL) unit, is mesalamine, also known as 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid. The empirical formula is C 7 H 7 NO 3 , representing a molecular weight of 153.14. The structural formula is: Each rectal suspension enema unit contains 4 grams of mesalamine. In addition to mesalamine the preparation contains the inactive ingredients carbomer 934P, edetate disodium, potassium acetate, potassium metabisulfite, purified water and xanthan gum. Sodium benzoate is added as a preservative. The disposable unit consists of an applicator tip protected by a polyethylene cover and lubricated with USP white petrolatum. The unit has a one-way valve to prevent back flow of the dispensed product.

By Substance

Drugs sharing the same substance name

APRISO MESALAMINE
(MESALAMINE) 0.375 g Extended-release
SALIX PHARMACEUTICALS, INC. FDA Rx Only

Each APRISO ® capsule is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine USP (5-aminosalicylic acid, 5-ASA), an aminosalicylate. The structural formula of mesalamine is: Molecular Weight: 153.14 Molecular Formula: C 7 H 7 NO 3 Each APRISO capsule contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above. The inactive ingredients of APRISO capsules are: anhydrous citric acid, aspartame, colloidal silicon dioxide, edible black ink, hypromellose, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, simethicone emulsion, ethyl acrylate/methyl methacrylate copolymer, talc, titanium dioxide, triethyl citrate, vanilla flavor. Each APRISO 0.375 g capsule contains 0.56 mg of phenylalanine. Chemical Structure

Canasa MESALAMINE
(MESALAMINE) 1000 mg Suppository
ALLERGAN, INC. FDA Rx Only

The active ingredient in CANASA 1000 mg suppositories for rectal use is mesalamine, also known as mesalazine or 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid, and is classified as an aminosalicylate. Each CANASA rectal suppository contains 1000 mg of mesalamine (USP) in a base of Hard Fat, NF. The empirical formula is C 7 H 7 NO 3 , representing a molecular weight of 153.14. The structural formula is: The structural formula for C7H7NO3, representing a molecular weight of 153.14.

Lialda MESALAMINE
(MESALAMINE) 1.2 g Delayed-release
TAKEDA PHARMACEUTICALS AMERICA, INC. FDA Rx Only

Each LIALDA delayed-release tablet for oral administration contains 1.2 g 5-aminosalicylic acid (5-ASA; mesalamine), an anti-inflammatory agent. Mesalamine also has the chemical name 5-amino-2-hydroxybenzoic acid and its structural formula is: Molecular formula: C 7 H 7 NO 3 Molecular weight: 153.14 The tablet is coated with a pH-dependent polymer film, which breaks down at or above pH 6.8, normally in the terminal ileum where mesalamine then begins to be released from the tablet core. The tablet core contains mesalamine with hydrophilic and lipophilic excipients and provides for extended release of mesalamine. The inactive ingredients of LIALDA are sodium carboxymethylcellulose, carnauba wax, stearic acid, silica (colloidal hydrated), sodium starch glycolate (type A), talc, magnesium stearate, methacrylic acid copolymer types A and B, triethylcitrate, titanium dioxide, red ferric oxide, and polyethylene glycol 6000. Chemical Structure

Mesalamine MESALAMINE
100 mg Delayed-release
AMERICAN HEALTH PACKAGING FDA Rx Only

Each Mesalamine delayed-release capsule for oral administration contains four 100 mg tablets of mesalamine, an aminosalicylate. Mesalamine delayed-release capsules contain acrylic based resin, methacrylic acid copolymer (Eudragit S), which dissolves at pH 7 or greater and releases mesalamine in the terminal ileum and beyond for topical anti-inflammatory action in the colon. Mesalamine, USP (also referred to as 5-aminosalicylic acid or 5-ASA) has the chemical name 5-amino-2-hydroxybenzoic acid. Its structural formula is: C 7 H 7 NO 3 M.W. 153.14 Inactive Ingredients: Each capsule contains colloidal silicon dioxide, dibutyl sebacate, hypromellose, iron oxide black, iron oxide red, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, potassium hydroxide, povidone, propylene glycol, shellac, sodium starch glycolate (potato), and talc. Structural formula

Mesalamine MESALAMINE
4 g/60 ml Suspension
ENCUBE ETHICALS, INC. FDA Rx Only

The active ingredient in mesalamine rectal suspension, USP enema, a disposable (60 mL) unit, is mesalamine, also known as 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid. The empirical formula is C 7 H 7 NO 3 , representing a molecular weight of 153.14. The structural formula is: Mesalamine rectal suspension, USP enema is supplied as a suspension for rectal administration. Each rectal suspension enema unit contains 4 grams of mesalamine. The inactive ingredients are carbomer 934P, edetate disodium, potassium acetate, potassium metabisulfite, purified water and xanthan gum. Sodium benzoate is added as a preservative. The disposable unit consists of an applicator tip protected by a polyethylene cover and lubricated with USP white petrolatum. The unit has a one-way valve to prevent back flow of the dispensed product. str

MESALAMINE MESALAMINE
0.375 g Extended-release
ALEMBIC PHARMACEUTICALS LIMITED FDA Rx Only

Each mesalamine capsule is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine, USP (5-aminosalicylic acid, 5-ASA), an aminosalicylate. The structural formula of mesalamine is: Molecular Weight: 153.14 Molecular Formula: C 7 H 7 NO 3 Each mesalamine extended-release capsule contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above. The inactive ingredients of mesalamine extended-release capsules are: microcrystalline cellulose, hypromellose, colloidal silicon dioxide, ethyl acrylate and methyl methacrylate 2:1 copolymer, magnesium stearate, methacrylic acid and methyl methacrylate 1:1 copolymer, talc, triethyl citrate, titanium dioxide and hypromellose phthalate. The capsule shell contains titanium dioxide, FD&C Blue 1, FD&C Red 40 and gelatin. The capsule shells are printed with edible black ink containing shellac, black iron oxide and potassium hydroxide. FDA approved dissolution test specifications differ from USP. structure

Mesalamine MESALAMINE
1000 mg Suppository
ACTAVIS PHARMA, INC. FDA Rx Only

The active ingredient in mesalamine 1000 mg suppositories for rectal use is mesalamine USP, also known as mesalazine or 5-aminosalicylic acid (5-ASA). Chemically, mesalamine, USP is 5-amino-2-hydroxybenzoic acid, and is classified as an aminosalicylate. Each mesalamine rectal suppository contains 1000 mg of mesalamine, USP in a base of hard fat base. The molecular formula is C 7 H 7 NO 3 , representing a molecular weight of 153.14. The structural formula is: 1

MESALAMINE MESALAMINE
1.2 g Delayed-release
BRYANT RANCH PREPACK FDA Rx Only

Each mesalamine delayed-release tablet, USP for oral administration contains 1.2 g 5-aminosalicylic acid (5-ASA; mesalamine), an anti-inflammatory agent. Mesalamine, USP also has the chemical name 5-amino-2-hydroxybenzoic acid and its structural formula is: Molecular formula:C 7 H 7 NO 3 Molecular weight:153.14 The tablet is coated with a pH-dependent polymer film, which breaks down at or above pH 6.8, normally in the terminal ileum where mesalamine, USP then begins to be released from the tablet core. The tablet core contains mesalamine with hydrophilic and lipophilic excipients and provides for extended release of mesalamine. The inactive ingredients of mesalamine delayed-release tablets, USP are colloidal silicon dioxide, magnesium stearate, carboxymethylcellulose sodium, sodium starch glycolate, hypromellose, microcrystalline cellulose, methacrylic acid-methyl methacrylate copolymer 1:1, methacrylic acid-methyl methacrylate copolymer 1:2, triethyl citrate, talc, polyvinyl alcohol, titanium dioxide, macrogol/PEG, iron oxide red and iron oxide yellow. FDA approved dissolution test specifications differ from USP.

Mesalamine MESALAMINE
0.375 g Extended-release
INGENUS PHARMACEUTICALS, LLC FDA Rx Only

Each mesalamine extended-release capsule, USP is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine USP (5-aminosalicylic acid, 5-ASA), an aminosalicylate. The structural formula of mesalamine is: Molecular Weight: 153.14 Molecular Formula: C 7 H 7 NO 3 Each mesalamine extended-release capsule, USP contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above. The inactive ingredients of mesalamine extended-release capsules, USP are: microcrystalline cellulose, ethyl cellulose, hypromellose, methacrylic acid and methyl methacrylate copolymer (1:1), triethyl citrate, talc, gelatin, FD&C Blue 2, titanium dioxide, shellac, potassium hydroxide and black iron oxide. FDA approved dissolution test specifications differ from the USP. Mesalamine Structural Formula

Mesalamine MESALAMINE
1.2 g Delayed-release
NORTHSTAR RXLLC FDA Rx Only

Each mesalamine delayed-release tablet, USP for oral administration contains 1.2 g 5-aminosalicylic acid (5-ASA; mesalamine), an anti-inflammatory agent. Mesalamine also has the chemical name 5-amino-2-hydroxybenzoic acid and its structural formula is: Molecular formula: C 7 H 7 NO 3 Molecular weight: 153.14 The tablet is coated with a pH-dependent polymer film, which breaks down at or above pH 6.8, normally in the terminal ileum where mesalamine then begins to be released from the tablet core. The tablet core contains mesalamine with hydrophilic and lipophilic excipients and provides for extended release of mesalamine. The inactive ingredients of mesalamine delayed-release tablets, USP are colloidal silicon dioxide, ferric oxide, hypromellose, magnesium stearate, methacrylic acid and methyl methacrylate copolymer, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc, titanium dioxide, triethyl citrate, the imprinting ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac. FDA approved dissolution test specifications differ from USP. mesalaminedrtabsstructure

Mesalamine MESALAMINE
800 mg Delayed-release
TEVA PHARMACEUTICALS, INC. FDA Rx Only

Each mesalamine delayed-release tablet, USP for oral administration contains 800 mg of mesalamine, USP, an aminosalicylate. Mesalamine delayed-release tablets, USP have an outer protective coat consisting of a combination of acrylic based resins, methacrylic acid and methyl methacrylate copolymer (1:2) and methacrylic acid and methyl methacrylate copolymer (1:1). The inner coat consists of an acrylic based resin, methacrylic acid and methyl methacrylate copolymer (1:2), which dissolves at pH 7 or greater, releasing mesalamine in the terminal ileum and beyond for topical anti-inflammatory action in the colon. Mesalamine, USP (also referred to as 5-aminosalicylic acid or 5-ASA) has the chemical name 5-amino-2-hydroxybenzoic acid; its structural formula is: Molecular Weight: 153.1 Molecular Formula: C 7 H 7 NO 3 Inactive Ingredients: Each tablet contains colloidal silicon dioxide, dibutyl sebacate, FD&C Red #40/Allura Red AC Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, iron oxide red, lactose monohydrate, magnesium stearate, methacrylic acid and methyl methacrylate copolymer (1:1), methacrylic acid and methyl methacrylate copolymer (1:2), polyethylene glycol 3350, polyethylene glycol 6000, polyvinyl alcohol, povidone K-30, sodium starch glycolate (type A), talc, and titanium dioxide. In addition the imprinting white ink contains isopropyl alcohol, n-butyl alcohol, propylene glycol, and shellac glaze. 1

Mesalamine MESALAMINE
1.2 g Delayed-release
AMERICAN HEALTH PACKAGING FDA Rx Only

Each mesalamine delayed-release tablet for oral administration contains 1.2 g 5-aminosalicylic acid (5-ASA; mesalamine), an anti-inflammatory agent. Mesalamine also has the chemical name 5-amino-2-hydroxybenzoic acid and its structural formula is: Molecular formula: C 7 H 7 NO 3 Molecular weight: 153.14 Mesalamine, USP is a light tan to pink colored, needle-shaped crystals. Color may darken on exposure to air. It is odorless or may have a slight characteristic odor. The tablet is coated with a pH dependent polymer film, which breaks down at or above pH 6.8, normally in the terminal ileum where mesalamine then begins to be released from the tablet core. The tablet core contains mesalamine with hydrophilic excipients and provides for extended release of mesalamine. Each mesalamine delayed-release tablet, USP intended for oral administration contains 1.2 g of mesalamine. In addition, each tablet contains the following inactive ingredients: carboxymethylcellulose sodium, colloidal silicon dioxide, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, triethyl citrate, talc and titanium dioxide. The Product meets USP Dissolution Test 4. Structural Formula

Mesalamine MESALAMINE
1.2 g Delayed-release
TAKEDA PHARMACEUTICALS AMERICA, INC. FDA Rx Only

Each mesalamine delayed-release tablet for oral administration contains 1.2 g 5-aminosalicylic acid (5-ASA; mesalamine), an anti-inflammatory agent. Mesalamine also has the chemical name 5-amino-2-hydroxybenzoic acid and its structural formula is: Molecular formula: C 7 H 7 NO 3 Molecular weight: 153.14 The tablet is coated with a pH-dependent polymer film, which breaks down at or above pH 6.8, normally in the terminal ileum where mesalamine then begins to be released from the tablet core . The tablet core contains mesalamine with hydrophilic and lipophilic excipients and provides for extended release of mesalamine. The inactive ingredients of a mesalamine delayed-release tablet are sodium carboxymethylcellulose, carnauba wax, stearic acid, silica (colloidal hydrated), sodium starch glycolate (type A), talc, magnesium stearate, methacrylic acid copolymer types A and B, triethylcitrate, titanium dioxide, red ferric oxide, and polyethylene glycol 6000. Chemical Structure

mesalamine MESALAMINE
1.2 g Delayed-release
ZYDUS PHARMACEUTICALS USA INC. FDA Rx Only

Each mesalamine delayed-release tablet for oral administration contains 1.2 g 5-aminosalicylic acid (5-ASA; mesalamine), an anti-inflammatory agent. Mesalamine also has the chemical name 5-amino-2-hydroxybenzoic acid and its structural formula is: Molecular formula: C 7 H 7 NO 3 Molecular weight: 153.14 Mesalamine, USP is a light tan to pink colored, needle-shaped crystals. Color may darken on exposure to air. It is odorless or may have a slight characteristic odor. The tablet is coated with a pH-dependent polymer film, which breaks down at or above pH 6.8, normally in the terminal ileum where mesalamine then begins to be released from the tablet core . The tablet core contains mesalamine with hydrophilic excipients and provides for extended release of mesalamine. Each mesalamine delayed-release tablet, USP intended for oral administration contains 1.2 g of mesalamine. In addition, each tablet contains the following inactive ingredients: carboxymethylcellulose sodium, colloidal silicon dioxide, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, triethyl citrate, talc and titanium dioxide. The Product meets USP Dissolution Test 4. Image

Mesalamine MESALAMINE
1000 mg Suppository
BRYANT RANCH PREPACK FDA Rx Only

The active ingredient in mesalamine suppositories 1000 mg for rectal use is mesalamine, also known as mesalazine or 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid, and is classified as an anti-inflammatory drug. Each mesalamine suppository contains 1000 mg of mesalamine (USP) in a base of Hard Fat, NF. The empirical formula is C 7 H 7 NO 3 , representing a molecular weight of 153.14. The structural formula is:

Mesalamine MESALAMINE
ANI PHARMACEUTICALS, INC. FDA Rx Only

The active ingredient in Mesalamine Rectal Suspension Enema, a disposable (60 mL) unit, is mesalamine, also known as 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid. The empirical formula is C 7 H 7 NO 3 , representing a molecular weight of 153.14. The structural formula is: Each rectal suspension enema unit contains 4 grams of mesalamine. In addition to mesalamine the preparation contains the inactive ingredients carbomer 934P, edetate disodium, potassium acetate, potassium metabisulfite, purified water and xanthan gum. Sodium benzoate is added as a preservative. The disposable unit consists of an applicator tip protected by a polyethylene cover and lubricated with USP white petrolatum. The unit has a one-way valve to prevent back flow of the dispensed product. structure

MESALAMINE MESALAMINE
0.375 g Extended-release
ALEMBIC PHARMACEUTICALS INC. FDA Rx Only

Each mesalamine capsule is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine, USP (5-aminosalicylic acid, 5-ASA), an aminosalicylate. The structural formula of mesalamine is: Molecular Weight: 153.14 Molecular Formula: C 7 H 7 NO 3 Each mesalamine extended-release capsule contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above. The inactive ingredients of mesalamine extended-release capsules are: microcrystalline cellulose, hypromellose, colloidal silicon dioxide, ethyl acrylate and methyl methacrylate 2:1 copolymer, magnesium stearate, methacrylic acid and methyl methacrylate 1:1 copolymer, talc, triethyl citrate, titanium dioxide and hypromellose phthalate. The capsule shell contains titanium dioxide, FD&C Blue 1, FD&C Red 40 and gelatin. The capsule shells are printed with edible black ink containing shellac, black iron oxide and potassium hydroxide. Meets USP Dissolution Test 5. structure

mesalamine MESALAMINE
0.375 g Extended-release
OCEANSIDE PHARMACEUTICALS FDA Rx Only

Each mesalamine extended-release capsule is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine USP (5-aminosalicylic acid, 5-ASA), an aminosalicylate. The structural formula of mesalamine is: Molecular Weight: 153.14 Molecular Formula: C 7 H 7 NO 3 Each mesalamine extended-release capsule contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above. The inactive ingredients of mesalamine extended-release capsules are: anhydrous citric acid, aspartame, colloidal silicon dioxide, edible black ink, hypromellose, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, simethicone emulsion, ethyl acrylate/methyl methacrylate copolymer, talc, titanium dioxide, triethyl citrate, vanilla flavor. Each mesalamine extended-release 0.375 g capsule contains 0.56 mg of phenylalanine. Apriso chemical structure

Mesalamine MESALAMINE
BRYANT RANCH PREPACK FDA Rx Only

The active ingredient in Mesalamine Rectal Suspension, USP Enema, a disposable (60 mL) unit, is mesalamine, also known as 5-aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid. The empirical formula is C 7 H 7 NO 3 , representing a molecular weight of 153.14. The structural formula is: Each rectal suspension enema unit contains 4 grams of mesalamine. In addition to mesalamine the preparation contains the inactive ingredients carbomer 934P, edetate disodium, potassium acetate, potassium metabisulfite, purified water and xanthan gum. Sodium benzoate is added as a preservative. The disposable unit consists of an applicator tip protected by a polyethylene cover and lubricated with USP white petrolatum. The unit has a one-way valve to prevent back flow of the dispensed product.

Mesalamine MESALAMINE
0.375 g Extended-release
UPSHER-SMITH LABORATORIES, LLC FDA Rx Only

Each Mesalamine Extended-Release Capsule, USP is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine USP (5-aminosalicylic acid, 5-ASA), an aminosalicylate. The structural formula of mesalamine is: Molecular Weight: 153.14 Molecular Formula: C 7 H 7 NO 3 Each Mesalamine Extended-Release Capsule, USP contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above. The inactive ingredients of Mesalamine Extended-Release Capsules, USP are: ethylcellulose, FD&C Blue No. 1, gelatin, hypromellose, methacrylic acid and methyl methacrylate copolymer, silicon dioxide, sodium lauryl sulfate, sugar spheres (corn starch and sucrose), talc, titanium dioxide and triethyl citrate. The imprinting ink has the following ingredients: ferrosoferric oxide, potassium hydroxide and shellac. FDA approved dissolution test specifications differ from USP. Chemical Structure

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