dexlansoprazole delayed release - Medication Listings

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Dexlansoprazole delayed release DEXLANSOPRAZOLE
A-S MEDICATION SOLUTIONS FDA Rx Only

The active ingredient in dexlansoprazole delayed-release capsules, a proton pump inhibitor, is (+)-2-[( R )-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl] methyl} sulfinyl]- 1H -benzimidazole, a compound that inhibits gastric acid secretion. Dexlansoprazole is the R -enantiomer of lansoprazole (a racemic mixture of the R - and S -enantiomers). Its empirical formula is: C 16 H 14 F 3 N 3 O 2 S, with a molecular weight of 369.36. Dexlansoprazole has the following chemical structure: Dexlansoprazole is a white to nearly white crystalline powder which melts with decomposition at 140°C. Dexlansoprazole is freely soluble in dimethylformamide, methanol, dichloromethane, ethanol, and ethyl acetate; and soluble in acetonitrile; slightly soluble in ether; and very slightly soluble in water; and practically insoluble in hexane. Dexlansoprazole is stable when exposed to light. Dexlansoprazole is more stable in neutral and alkaline conditions than acidic conditions. Dexlansoprazole is supplied for oral administration as a dual delayed-release formulation in capsules. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles [see Clinical Pharmacology (12.3) ] . Dexlansoprazole delayed-release capsules are available in two dosage strengths: 30 and 60 mg, per capsule. Each capsule contains enteric-coated granules consisting of dexlansoprazole (active ingredient) and the following inactive ingredients: sugar spheres, magnesium carbonate, sucrose, low-substituted hydroxypropyl cellulose, titanium dioxide, hydroxypropyl cellulose, hypromellose 2910, talc, methacrylic acid copolymers, polyethylene glycol 8000, triethyl citrate, polysorbate 80, and colloidal silicon dioxide. The components of the capsule shell include the following inactive ingredients: hypromellose, carrageenan and potassium chloride. Based on the capsule shell color, blue contains FD&C Blue No. 2 (or FD&C Blue No. 2 aluminum lake); gray contains black ferric oxide; and both contain titanium dioxide. Chemical Structure

Dexlansoprazole delayed release DEXLANSOPRAZOLE
UPSHER-SMITH LABORATORIES, LLC FDA Rx Only

The active ingredient in dexlansoprazole delayed-release capsules, a proton pump inhibitor, is (+)-2-[( R )-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl] methyl} sulfinyl]- 1H -benzimidazole, a compound that inhibits gastric acid secretion. Dexlansoprazole is the R -enantiomer of lansoprazole (a racemic mixture of the R - and S -enantiomers). Its empirical formula is: C 16 H 14 F 3 N 3 O 2 S, with a molecular weight of 369.36. Dexlansoprazole has the following chemical structure: Dexlansoprazole is a white to nearly white crystalline powder which melts with decomposition at 140°C. Dexlansoprazole is freely soluble in dimethylformamide, methanol, dichloromethane, ethanol, and ethyl acetate; and soluble in acetonitrile; slightly soluble in ether; and very slightly soluble in water; and practically insoluble in hexane. Dexlansoprazole is stable when exposed to light. Dexlansoprazole is more stable in neutral and alkaline conditions than acidic conditions. Dexlansoprazole is supplied for oral administration as a dual delayed-release formulation in capsules. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles [see Clinical Pharmacology (12.3) ] . Dexlansoprazole delayed-release capsules are available in two dosage strengths: 30 and 60 mg, per capsule. Each capsule contains enteric-coated granules consisting of dexlansoprazole (active ingredient) and the following inactive ingredients: sugar spheres, hypromellose, sucrose, sodium hydroxide, magnesium carbonate, titanium dioxide, methacrylic acid and ethyl acrylate copolymer dispersion, triethyl citrate, polyethylene glycol, polysorbate 80 and talc. The components of the capsule shell include the following inactive ingredients: FDA/E172 Black iron oxide, titanium dioxide, hypromellose, and FD&C Blue #1. The black imprinting ink contains: shellac, black iron oxide, FD&C Blue #2, FD&C Red #40, FD&C Blue #1, and D&C Yellow #10. Chemical Structure

Dexlansoprazole delayed release DEXLANSOPRAZOLE
A-S MEDICATION SOLUTIONS FDA Rx Only

The active ingredient in dexlansoprazole delayed-release capsules, a proton pump inhibitor, is (+)-2-[( R )-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl] methyl} sulfinyl]- 1H -benzimidazole, a compound that inhibits gastric acid secretion. Dexlansoprazole is the R -enantiomer of lansoprazole (a racemic mixture of the R - and S -enantiomers). Its empirical formula is: C 16 H 14 F 3 N 3 O 2 S, with a molecular weight of 369.36. Dexlansoprazole has the following chemical structure: Dexlansoprazole is a white to nearly white crystalline powder which melts with decomposition at 140°C. Dexlansoprazole is freely soluble in dimethylformamide, methanol, dichloromethane, ethanol, and ethyl acetate; and soluble in acetonitrile; slightly soluble in ether; and very slightly soluble in water; and practically insoluble in hexane. Dexlansoprazole is stable when exposed to light. Dexlansoprazole is more stable in neutral and alkaline conditions than acidic conditions. Dexlansoprazole is supplied for oral administration as a dual delayed-release formulation in capsules. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles [see Clinical Pharmacology (12.3) ] . Dexlansoprazole delayed-release capsules are available in two dosage strengths: 30 and 60 mg, per capsule. Each capsule contains enteric-coated granules consisting of dexlansoprazole (active ingredient) and the following inactive ingredients: sugar spheres, hypromellose, sucrose, sodium hydroxide, magnesium carbonate, titanium dioxide, methacrylic acid and ethyl acrylate copolymer dispersion, triethyl citrate, polyethylene glycol, polysorbate 80 and talc. The components of the capsule shell include the following inactive ingredients: FDA/E172 Black iron oxide, titanium dioxide, hypromellose, and FD&C Blue #1. The black imprinting ink contains: shellac, black iron oxide, FD&C Blue #2, FD&C Red #40, FD&C Blue #1, and D&C Yellow #10. Chemical Structure

Dexlansoprazole delayed release DEXLANSOPRAZOLE
GOLDEN STATE MEDICAL SUPPLY, INC. FDA Rx Only

The active ingredient in dexlansoprazole delayed-release capsules, a proton pump inhibitor, is (+)-2-[( R )-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl] methyl} sulfinyl]- 1H -benzimidazole, a compound that inhibits gastric acid secretion. Dexlansoprazole is the R -enantiomer of lansoprazole (a racemic mixture of the R - and S -enantiomers). Its empirical formula is: C 16 H 14 F 3 N 3 O 2 S, with a molecular weight of 369.36. Dexlansoprazole has the following chemical structure: Dexlansoprazole is a white to nearly white crystalline powder which melts with decomposition at 140°C. Dexlansoprazole is freely soluble in dimethylformamide, methanol, dichloromethane, ethanol, and ethyl acetate; and soluble in acetonitrile; slightly soluble in ether; and very slightly soluble in water; and practically insoluble in hexane. Dexlansoprazole is stable when exposed to light. Dexlansoprazole is more stable in neutral and alkaline conditions than acidic conditions. Dexlansoprazole is supplied for oral administration as a dual delayed-release formulation in capsules. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles [see Clinical Pharmacology (12.3) ] . Dexlansoprazole delayed-release capsules are available in two dosage strengths: 30 and 60 mg, per capsule. Each capsule contains enteric-coated granules consisting of dexlansoprazole (active ingredient) and the following inactive ingredients: sugar spheres, hypromellose, sucrose, sodium hydroxide, magnesium carbonate, titanium dioxide, methacrylic acid and ethyl acrylate copolymer dispersion, triethyl citrate, polyethylene glycol, polysorbate 80 and talc. The components of the capsule shell include the following inactive ingredients: FDA/E172 Black iron oxide, titanium dioxide, hypromellose, and FD&C Blue #1. The black imprinting ink contains: shellac, black iron oxide, FD&C Blue #2, FD&C Red #40, FD&C Blue #1, and D&C Yellow #10. Chemical Structure

Dexlansoprazole delayed release DEXLANSOPRAZOLE
BRYANT RANCH PREPACK FDA Rx Only

The active ingredient in dexlansoprazole delayed-release capsules, a proton pump inhibitor, is (+)-2-[( R )-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl] methyl} sulfinyl]- 1H -benzimidazole, a compound that inhibits gastric acid secretion. Dexlansoprazole is the R -enantiomer of lansoprazole (a racemic mixture of the R - and S -enantiomers). Its empirical formula is: C 16 H 14 F 3 N 3 O 2 S, with a molecular weight of 369.36. Dexlansoprazole has the following chemical structure: Dexlansoprazole is a white to nearly white crystalline powder which melts with decomposition at 140°C. Dexlansoprazole is freely soluble in dimethylformamide, methanol, dichloromethane, ethanol, and ethyl acetate; and soluble in acetonitrile; slightly soluble in ether; and very slightly soluble in water; and practically insoluble in hexane. Dexlansoprazole is stable when exposed to light. Dexlansoprazole is more stable in neutral and alkaline conditions than acidic conditions. Dexlansoprazole is supplied for oral administration as a dual delayed-release formulation in capsules. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles [see Clinical Pharmacology (12.3) ] . Dexlansoprazole delayed-release capsules are available in two dosage strengths: 30 and 60 mg, per capsule. Each capsule contains enteric-coated granules consisting of dexlansoprazole (active ingredient) and the following inactive ingredients: sugar spheres, hypromellose, sucrose, sodium hydroxide, magnesium carbonate, titanium dioxide, methacrylic acid and ethyl acrylate copolymer dispersion, triethyl citrate, polyethylene glycol, polysorbate 80 and talc. The components of the capsule shell include the following inactive ingredients: FDA/E172 Black iron oxide, titanium dioxide, hypromellose, and FD&C Blue #1. The black imprinting ink contains: shellac, black iron oxide, FD&C Blue #2, FD&C Red #40, FD&C Blue #1, and D&C Yellow #10.

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