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NAPROXEN AND ESOMEPRAZOLE MAGNESIUM

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Naproxen and esomeprazole magnesium NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
PREFERRED PHARMACEUTICALS INC. FDA Rx Only

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen, USP which is an NSAID and esomeprazole magnesium, USP which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen, USP and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, talc, triethy citrate, hypromellose, macrogol, sodium lauryl sulfate, magnesium oxide, polyethylene glycol, ferric oxide yellow. The imprinting ink contains shellac glaze, black iron oxide, propylene glycol, ammonium hydroxide. The chemical name for naproxen, USP is (S)-2-(6-Methoxy-naphth-2-yl) propionic acid. Naproxen, USP has the following structure: Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline powder. It is practically insoluble in water and soluble in ethanol and methanol. The octanol/water partition coefficient of naproxen is 3.18. The chemical name for esomeprazole is Magnesium bis [5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulphinyl]-1Hbenzimidazol-1- ide]dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. Its molecular formula is C 34 H 36 N 6 O 6 S 2 Mg.2H 2 O with molecular weight of 749.15 as a dihydrate and 713.15 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored powder. It contains 2 moles of water of solvation and is slightly soluble in methanol, practically insoluble in water and heptane. The stability of esomeprazole magnesium, USP is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. naproxen-structure esomeprazole-structure

Naproxen and esomeprazole magnesium NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
DR. REDDY'S LABORATORIES LIMITED FDA Rx Only

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as modified capsule shaped, off white to yellow colored 375 mg/20 mg and 500 mg/20 mg, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) or 500 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) for oral administration. The inactive ingredients are ammonium hydroxide, croscarmellose sodium, ferric oxide yellow, hypromellose, iron oxide black, lactose monohydrate, magnesium oxide, magnesium stearate, methacrylic acid copolymer, poloxamer, polyethylene glycol 400, povidone, propylene glycol, shellac glaze, simethicone, sodium hydroxide, sodium lauryl sulphate, talc, titanium dioxide and triethyl citrate. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure: Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen USP is white to off-white practically odourless crystalline powder. It is soluble in chloroform, in dehydrated alcohol and in alcohol, sparingly soluble in ether and practically insoluble in water. The octanol/water partition coefficient of naproxen at pH 6.48 is 1.5. The chemical name for esomeprazole is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium amorphous. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C 17 H 18 N 3 O 3 S) 2 Mg with molecular weight of 713.1. The structural formula is: The esomepraozle magnesium USP is a white to pale cream colored powder. It is slightly soluble in methanol and soluble in N,N-Dimethyl formamide and practically insoluble in heptane and in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C.

Naproxen and esomeprazole magnesium NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
PREFERRED PHARMACEUTICALS INC. FDA Rx Only

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as modified capsule shaped, off white to yellow colored 375 mg/20 mg and 500 mg/20 mg, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) or 500 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) for oral administration. The inactive ingredients are ammonium hydroxide, croscarmellose sodium, ferric oxide yellow, hypromellose, iron oxide black, lactose monohydrate, magnesium oxide, magnesium stearate, methacrylic acid copolymer, poloxamer, polyethylene glycol 400, povidone, propylene glycol, shellac glaze, simethicone, sodium hydroxide, sodium lauryl sulphate, talc, titanium dioxide and triethyl citrate. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure: Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen USP is white to off-white practically odourless crystalline powder. It is soluble in chloroform, in dehydrated alcohol and in alcohol, sparingly soluble in ether and practically insoluble in water. The octanol/water partition coefficient of naproxen at pH 6.48 is 1.5. The chemical name for esomeprazole is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium amorphous. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C 17 H 18 N 3 O 3 S) 2 Mg with molecular weight of 713.1. The structural formula is: The esomepraozle magnesium USP is a white to pale cream colored powder. It is slightly soluble in methanol and soluble in N,N-Dimethyl formamide and practically insoluble in heptane and in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. structure1 structure2

Naproxen and esomeprazole magnesium NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
PHOENIX RX LLC FDA Rx Only

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen, USP which is an NSAID and esomeprazole magnesium, USP which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen, USP and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, talc, triethy citrate, hypromellose, macrogol, sodium lauryl sulfate, magnesium oxide, polyethylene glycol, ferric oxide yellow. The imprinting ink contains shellac glaze, black iron oxide, propylene glycol, ammonium hydroxide. The chemical name for naproxen, USP is (S)-2-(6-Methoxy-naphth-2-yl) propionic acid. Naproxen, USP has the following structure: Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline powder. It is practically insoluble in water and soluble in ethanol and methanol. The octanol/water partition coefficient of naproxen is 3.18. The chemical name for esomeprazole is Magnesium bis [5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulphinyl]-1Hbenzimidazol-1- ide]dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. Its molecular formula is C 34 H 36 N 6 O 6 S 2 Mg.2H 2 O with molecular weight of 749.15 as a dihydrate and 713.15 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored powder. It contains 2 moles of water of solvation and is slightly soluble in methanol, practically insoluble in water and heptane. The stability of esomeprazole magnesium, USP is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. naproxen-structure esomeprazole-structure

Naproxen and esomeprazole magnesium NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
PREFERRED PHARMACEUTICALS INC FDA Rx Only

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets (naproxen and esomeprazole magnesium) is combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen and 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) for oral administration. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide yellow, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, talc, plasacryl, polyethylene glycol, polysorbate 80, povidone, titanium dioxide. The imprinting ink contains ammonium hydroxide, iron oxide black, propylene glycol, shellac glaze. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure: Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The chemical name for esomeprazole, USP is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H -benzimidazole-1-yl) magnesium trihydrate. Esomeprazole, USP is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C 17 H 18 N 3 O 3 S)2Mg x 3 H 2 O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. structure1 structure2

Naproxen and esomeprazole magnesium NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
BRYANT RANCH PREPACK FDA Rx Only

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen, USP which is an NSAID and esomeprazole magnesium, USP which is a Proton Pump Inhibitor (PPI). Naproxen, USP and esomeprazole magnesium, USP is combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen, USP and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, talc, triethy citrate, hypromellose, macrogol, sodium lauryl sulfate, magnesium oxide, polyethylene glycol, ferric oxide yellow. The imprinting ink contains shellac glaze, black iron oxide, propylene glycol, ammonium hydroxide. The chemical name for naproxen, USP is (S)-2-(6-Methoxy-naphth-2-yl) propionic acid. Naproxen, USP has the following structure: Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline powder. It is practically insoluble in water and soluble in ethanol and methanol. The octanol/water partition coefficient of naproxen is 3.18. The chemical name for esomeprazole is Magnesium bis [5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulphinyl]-1Hbenzimidazol-1- ide]dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. Its molecular formula is C 34 H 36 N 6 O 6 S 2 Mg.2H 2 O with molecular weight of 749.15 as a dihydrate and 713.15 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored powder. It contains 2 moles of water of solvation and is slightly soluble in methanol, practically insoluble in water and heptane. The stability of esomeprazole magnesium, USP is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C.

Naproxen and esomeprazole magnesium NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
BRYANT RANCH PREPACK FDA Rx Only

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as modified capsule shaped, off white to yellow colored 375 mg/20 mg and 500 mg/20 mg, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) or 500 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) for oral administration. The inactive ingredients are ammonium hydroxide, croscarmellose sodium, ferric oxide yellow, hypromellose, iron oxide black, lactose monohydrate, magnesium oxide, magnesium stearate, methacrylic acid copolymer, poloxamer, polyethylene glycol 400, povidone, propylene glycol, shellac glaze, simethicone, sodium hydroxide, sodium lauryl sulphate, talc, titanium dioxide and triethyl citrate. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure: Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen USP is white to off-white practically odourless crystalline powder. It is soluble in chloroform, in dehydrated alcohol and in alcohol, sparingly soluble in ether and practically insoluble in water. The octanol/water partition coefficient of naproxen at pH 6.48 is 1.5. The chemical name for esomeprazole is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium amorphous. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C 17 H 18 N 3 O 3 S) 2 Mg with molecular weight of 713.1. The structural formula is: The esomepraozle magnesium USP is a white to pale cream colored powder. It is slightly soluble in methanol and soluble in N,N-Dimethyl formamide and practically insoluble in heptane and in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C.

Naproxen and esomeprazole magnesium NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
PHOENIX RX LLC FDA Rx Only

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen, USP which is an NSAID and esomeprazole magnesium, USP which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen, USP and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, talc, triethy citrate, hypromellose, macrogol, sodium lauryl sulfate, magnesium oxide, polyethylene glycol, ferric oxide yellow. The imprinting ink contains shellac glaze, black iron oxide, propylene glycol, ammonium hydroxide. The chemical name for naproxen, USP is (S)-2-(6-Methoxy-naphth-2-yl) propionic acid. Naproxen, USP has the following structure: Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline powder. It is practically insoluble in water and soluble in ethanol and methanol. The octanol/water partition coefficient of naproxen is 3.18. The chemical name for esomeprazole is Magnesium bis [5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulphinyl]-1Hbenzimidazol-1- ide]dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. Its molecular formula is C 34 H 36 N 6 O 6 S 2 Mg.2H 2 O with molecular weight of 749.15 as a dihydrate and 713.15 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored powder. It contains 2 moles of water of solvation and is slightly soluble in methanol, practically insoluble in water and heptane. The stability of esomeprazole magnesium, USP is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. naproxen-structure esomeprazole-structure

Naproxen and esomeprazole magnesium NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
AJANTA PHARMA USA INC. FDA Rx Only

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen, USP which is an NSAID and esomeprazole magnesium, USP which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen, USP and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, talc, triethy citrate, hypromellose, macrogol, sodium lauryl sulfate, magnesium oxide, polyethylene glycol, ferric oxide yellow. The imprinting ink contains shellac glaze, black iron oxide, propylene glycol, ammonium hydroxide. The chemical name for naproxen, USP is (S)-2-(6-Methoxy-naphth-2-yl) propionic acid. Naproxen, USP has the following structure: Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline powder. It is practically insoluble in water and soluble in ethanol and methanol. The octanol/water partition coefficient of naproxen is 3.18. The chemical name for esomeprazole is Magnesium bis [5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulphinyl]-1Hbenzimidazol-1- ide]dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. Its molecular formula is C 34 H 36 N 6 O 6 S 2 Mg.2H 2 O with molecular weight of 749.15 as a dihydrate and 713.15 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored powder. It contains 2 moles of water of solvation and is slightly soluble in methanol, practically insoluble in water and heptane. The stability of esomeprazole magnesium, USP is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. naproxen-structure esomeprazole-structure

Naproxen and esomeprazole magnesium NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
ASCLEMED USA, INC. FDA Rx Only

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as modified capsule shaped, off white to yellow colored 375 mg/20 mg and 500 mg/20 mg, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) or 500 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) for oral administration. The inactive ingredients are ammonium hydroxide, croscarmellose sodium, ferric oxide yellow, hypromellose, iron oxide black, lactose monohydrate, magnesium oxide, magnesium stearate, methacrylic acid copolymer, poloxamer, polyethylene glycol 400, povidone, propylene glycol, shellac glaze, simethicone, sodium hydroxide, sodium lauryl sulphate, talc, titanium dioxide and triethyl citrate. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure: Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen USP is white to off-white practically odourless crystalline powder. It is soluble in chloroform, in dehydrated alcohol and in alcohol, sparingly soluble in ether and practically insoluble in water. The octanol/water partition coefficient of naproxen at pH 6.48 is 1.5. The chemical name for esomeprazole is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium amorphous. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C 17 H 18 N 3 O 3 S) 2 Mg with molecular weight of 713.1. The structural formula is: The esomepraozle magnesium USP is a white to pale cream colored powder. It is slightly soluble in methanol and soluble in N,N-Dimethyl formamide and practically insoluble in heptane and in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. structure1 structure2

Naproxen and esomeprazole magnesium NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
SCIEGEN PHARMACEUTICALS, INC FDA Rx Only

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets (naproxen and esomeprazole magnesium) is combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen and 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) for oral administration. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide yellow, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, talc, plasacryl, polyethylene glycol, polysorbate 80, povidone, titanium dioxide. The imprinting ink contains ammonium hydroxide, iron oxide black, propylene glycol, shellac glaze. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure: Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The chemical name for esomeprazole, USP is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H -benzimidazole-1-yl) magnesium trihydrate. Esomeprazole, USP is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C 17 H 18 N 3 O 3 S)2Mg x 3 H 2 O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. structure1 structure2

By Generic Name

Drugs with the same generic name (different brands)

Naproxen and esomeprazole magnesium NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
PREFERRED PHARMACEUTICALS INC FDA Rx Only

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets (naproxen and esomeprazole magnesium) is combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen and 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) for oral administration. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide yellow, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, talc, plasacryl, polyethylene glycol, polysorbate 80, povidone, titanium dioxide. The imprinting ink contains ammonium hydroxide, iron oxide black, propylene glycol, shellac glaze. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure: Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The chemical name for esomeprazole, USP is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H -benzimidazole-1-yl) magnesium trihydrate. Esomeprazole, USP is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C 17 H 18 N 3 O 3 S)2Mg x 3 H 2 O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. structure1 structure2

Naproxen and esomeprazole magnesium NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
BRYANT RANCH PREPACK FDA Rx Only

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen, USP which is an NSAID and esomeprazole magnesium, USP which is a Proton Pump Inhibitor (PPI). Naproxen, USP and esomeprazole magnesium, USP is combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen, USP and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, talc, triethy citrate, hypromellose, macrogol, sodium lauryl sulfate, magnesium oxide, polyethylene glycol, ferric oxide yellow. The imprinting ink contains shellac glaze, black iron oxide, propylene glycol, ammonium hydroxide. The chemical name for naproxen, USP is (S)-2-(6-Methoxy-naphth-2-yl) propionic acid. Naproxen, USP has the following structure: Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline powder. It is practically insoluble in water and soluble in ethanol and methanol. The octanol/water partition coefficient of naproxen is 3.18. The chemical name for esomeprazole is Magnesium bis [5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulphinyl]-1Hbenzimidazol-1- ide]dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. Its molecular formula is C 34 H 36 N 6 O 6 S 2 Mg.2H 2 O with molecular weight of 749.15 as a dihydrate and 713.15 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored powder. It contains 2 moles of water of solvation and is slightly soluble in methanol, practically insoluble in water and heptane. The stability of esomeprazole magnesium, USP is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C.

Naproxen and esomeprazole magnesium NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
BRYANT RANCH PREPACK FDA Rx Only

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as modified capsule shaped, off white to yellow colored 375 mg/20 mg and 500 mg/20 mg, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) or 500 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) for oral administration. The inactive ingredients are ammonium hydroxide, croscarmellose sodium, ferric oxide yellow, hypromellose, iron oxide black, lactose monohydrate, magnesium oxide, magnesium stearate, methacrylic acid copolymer, poloxamer, polyethylene glycol 400, povidone, propylene glycol, shellac glaze, simethicone, sodium hydroxide, sodium lauryl sulphate, talc, titanium dioxide and triethyl citrate. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure: Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen USP is white to off-white practically odourless crystalline powder. It is soluble in chloroform, in dehydrated alcohol and in alcohol, sparingly soluble in ether and practically insoluble in water. The octanol/water partition coefficient of naproxen at pH 6.48 is 1.5. The chemical name for esomeprazole is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium amorphous. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C 17 H 18 N 3 O 3 S) 2 Mg with molecular weight of 713.1. The structural formula is: The esomepraozle magnesium USP is a white to pale cream colored powder. It is slightly soluble in methanol and soluble in N,N-Dimethyl formamide and practically insoluble in heptane and in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C.

Naproxen and esomeprazole magnesium NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
ASCLEMED USA, INC. FDA Rx Only

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as modified capsule shaped, off white to yellow colored 375 mg/20 mg and 500 mg/20 mg, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) or 500 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) for oral administration. The inactive ingredients are ammonium hydroxide, croscarmellose sodium, ferric oxide yellow, hypromellose, iron oxide black, lactose monohydrate, magnesium oxide, magnesium stearate, methacrylic acid copolymer, poloxamer, polyethylene glycol 400, povidone, propylene glycol, shellac glaze, simethicone, sodium hydroxide, sodium lauryl sulphate, talc, titanium dioxide and triethyl citrate. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure: Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen USP is white to off-white practically odourless crystalline powder. It is soluble in chloroform, in dehydrated alcohol and in alcohol, sparingly soluble in ether and practically insoluble in water. The octanol/water partition coefficient of naproxen at pH 6.48 is 1.5. The chemical name for esomeprazole is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium amorphous. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C 17 H 18 N 3 O 3 S) 2 Mg with molecular weight of 713.1. The structural formula is: The esomepraozle magnesium USP is a white to pale cream colored powder. It is slightly soluble in methanol and soluble in N,N-Dimethyl formamide and practically insoluble in heptane and in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. structure1 structure2

Naproxen and esomeprazole magnesium NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
PHOENIX RX LLC FDA Rx Only

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen, USP which is an NSAID and esomeprazole magnesium, USP which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen, USP and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, talc, triethy citrate, hypromellose, macrogol, sodium lauryl sulfate, magnesium oxide, polyethylene glycol, ferric oxide yellow. The imprinting ink contains shellac glaze, black iron oxide, propylene glycol, ammonium hydroxide. The chemical name for naproxen, USP is (S)-2-(6-Methoxy-naphth-2-yl) propionic acid. Naproxen, USP has the following structure: Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline powder. It is practically insoluble in water and soluble in ethanol and methanol. The octanol/water partition coefficient of naproxen is 3.18. The chemical name for esomeprazole is Magnesium bis [5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulphinyl]-1Hbenzimidazol-1- ide]dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. Its molecular formula is C 34 H 36 N 6 O 6 S 2 Mg.2H 2 O with molecular weight of 749.15 as a dihydrate and 713.15 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored powder. It contains 2 moles of water of solvation and is slightly soluble in methanol, practically insoluble in water and heptane. The stability of esomeprazole magnesium, USP is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. naproxen-structure esomeprazole-structure

Naproxen and esomeprazole magnesium NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
SCIEGEN PHARMACEUTICALS, INC FDA Rx Only

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets (naproxen and esomeprazole magnesium) is combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen and 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) for oral administration. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide yellow, magnesium oxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, talc, plasacryl, polyethylene glycol, polysorbate 80, povidone, titanium dioxide. The imprinting ink contains ammonium hydroxide, iron oxide black, propylene glycol, shellac glaze. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure: Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. The chemical name for esomeprazole, USP is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H -benzimidazole-1-yl) magnesium trihydrate. Esomeprazole, USP is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C 17 H 18 N 3 O 3 S)2Mg x 3 H 2 O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. structure1 structure2

Naproxen and esomeprazole magnesium NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
PREFERRED PHARMACEUTICALS INC. FDA Rx Only

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen, USP which is an NSAID and esomeprazole magnesium, USP which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen, USP and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, talc, triethy citrate, hypromellose, macrogol, sodium lauryl sulfate, magnesium oxide, polyethylene glycol, ferric oxide yellow. The imprinting ink contains shellac glaze, black iron oxide, propylene glycol, ammonium hydroxide. The chemical name for naproxen, USP is (S)-2-(6-Methoxy-naphth-2-yl) propionic acid. Naproxen, USP has the following structure: Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline powder. It is practically insoluble in water and soluble in ethanol and methanol. The octanol/water partition coefficient of naproxen is 3.18. The chemical name for esomeprazole is Magnesium bis [5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulphinyl]-1Hbenzimidazol-1- ide]dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. Its molecular formula is C 34 H 36 N 6 O 6 S 2 Mg.2H 2 O with molecular weight of 749.15 as a dihydrate and 713.15 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored powder. It contains 2 moles of water of solvation and is slightly soluble in methanol, practically insoluble in water and heptane. The stability of esomeprazole magnesium, USP is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. naproxen-structure esomeprazole-structure

Naproxen and esomeprazole magnesium NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
DR. REDDY'S LABORATORIES LIMITED FDA Rx Only

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as modified capsule shaped, off white to yellow colored 375 mg/20 mg and 500 mg/20 mg, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) or 500 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) for oral administration. The inactive ingredients are ammonium hydroxide, croscarmellose sodium, ferric oxide yellow, hypromellose, iron oxide black, lactose monohydrate, magnesium oxide, magnesium stearate, methacrylic acid copolymer, poloxamer, polyethylene glycol 400, povidone, propylene glycol, shellac glaze, simethicone, sodium hydroxide, sodium lauryl sulphate, talc, titanium dioxide and triethyl citrate. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure: Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen USP is white to off-white practically odourless crystalline powder. It is soluble in chloroform, in dehydrated alcohol and in alcohol, sparingly soluble in ether and practically insoluble in water. The octanol/water partition coefficient of naproxen at pH 6.48 is 1.5. The chemical name for esomeprazole is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium amorphous. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C 17 H 18 N 3 O 3 S) 2 Mg with molecular weight of 713.1. The structural formula is: The esomepraozle magnesium USP is a white to pale cream colored powder. It is slightly soluble in methanol and soluble in N,N-Dimethyl formamide and practically insoluble in heptane and in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C.

Naproxen and esomeprazole magnesium NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
AJANTA PHARMA USA INC. FDA Rx Only

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen, USP which is an NSAID and esomeprazole magnesium, USP which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen, USP and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, talc, triethy citrate, hypromellose, macrogol, sodium lauryl sulfate, magnesium oxide, polyethylene glycol, ferric oxide yellow. The imprinting ink contains shellac glaze, black iron oxide, propylene glycol, ammonium hydroxide. The chemical name for naproxen, USP is (S)-2-(6-Methoxy-naphth-2-yl) propionic acid. Naproxen, USP has the following structure: Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline powder. It is practically insoluble in water and soluble in ethanol and methanol. The octanol/water partition coefficient of naproxen is 3.18. The chemical name for esomeprazole is Magnesium bis [5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulphinyl]-1Hbenzimidazol-1- ide]dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. Its molecular formula is C 34 H 36 N 6 O 6 S 2 Mg.2H 2 O with molecular weight of 749.15 as a dihydrate and 713.15 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored powder. It contains 2 moles of water of solvation and is slightly soluble in methanol, practically insoluble in water and heptane. The stability of esomeprazole magnesium, USP is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. naproxen-structure esomeprazole-structure

Naproxen and esomeprazole magnesium NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
PREFERRED PHARMACEUTICALS INC. FDA Rx Only

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen which is an NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as modified capsule shaped, off white to yellow colored 375 mg/20 mg and 500 mg/20 mg, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) or 500 mg of naproxen USP and 20 mg of esomeprazole (equivalent to 20.71 mg esomeprazole magnesium USP amorphous form) for oral administration. The inactive ingredients are ammonium hydroxide, croscarmellose sodium, ferric oxide yellow, hypromellose, iron oxide black, lactose monohydrate, magnesium oxide, magnesium stearate, methacrylic acid copolymer, poloxamer, polyethylene glycol 400, povidone, propylene glycol, shellac glaze, simethicone, sodium hydroxide, sodium lauryl sulphate, talc, titanium dioxide and triethyl citrate. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure: Naproxen has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen USP is white to off-white practically odourless crystalline powder. It is soluble in chloroform, in dehydrated alcohol and in alcohol, sparingly soluble in ether and practically insoluble in water. The octanol/water partition coefficient of naproxen at pH 6.48 is 1.5. The chemical name for esomeprazole is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium amorphous. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C 17 H 18 N 3 O 3 S) 2 Mg with molecular weight of 713.1. The structural formula is: The esomepraozle magnesium USP is a white to pale cream colored powder. It is slightly soluble in methanol and soluble in N,N-Dimethyl formamide and practically insoluble in heptane and in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. structure1 structure2

Naproxen and esomeprazole magnesium NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
PHOENIX RX LLC FDA Rx Only

The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen, USP which is an NSAID and esomeprazole magnesium, USP which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen, USP and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, talc, triethy citrate, hypromellose, macrogol, sodium lauryl sulfate, magnesium oxide, polyethylene glycol, ferric oxide yellow. The imprinting ink contains shellac glaze, black iron oxide, propylene glycol, ammonium hydroxide. The chemical name for naproxen, USP is (S)-2-(6-Methoxy-naphth-2-yl) propionic acid. Naproxen, USP has the following structure: Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 . Naproxen, USP is an odorless, white to off-white crystalline powder. It is practically insoluble in water and soluble in ethanol and methanol. The octanol/water partition coefficient of naproxen is 3.18. The chemical name for esomeprazole is Magnesium bis [5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulphinyl]-1Hbenzimidazol-1- ide]dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. Its molecular formula is C 34 H 36 N 6 O 6 S 2 Mg.2H 2 O with molecular weight of 749.15 as a dihydrate and 713.15 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored powder. It contains 2 moles of water of solvation and is slightly soluble in methanol, practically insoluble in water and heptane. The stability of esomeprazole magnesium, USP is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. naproxen-structure esomeprazole-structure

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Uses treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

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P & L DEVELOPMENT, LLC FDA OTC

Uses treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Esomeprazole ESOMEPRAZOLE MAGNESIUM

Use treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Esomeprazole ESOMEPRAZOLE MAGNESIUM
HARRIS TEETER FDA OTC

Use • treats frequent heartburn (occurs 2 or more days a week) • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Esomeprazole ESOMEPRAZOLE MAGNESIUM
OHM LABORATORIES INC. FDA OTC

Use • treats frequent heartburn (occurs 2 or more days a week) • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Esomeprazole ESOMEPRAZOLE MAGNESIUM
VALU MERCHANDISERS COMPANY FDA OTC

Use • treats frequent heartburn (occurs 2 or more days a week) • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

esomeprazole ESOMEPRAZOLE
#20 20 mg
THE KROGER COMPANY FDA OTC

Uses treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Esomeprazole ESOMEPRAZOLE
#20 20 mg
SAFEWAY, INC. FDA OTC

Use • treats frequent heartburn (occurs 2 or more days a week) • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Esomeprazole ESOMEPRAZOLE
#20 20 mg
SUN PHARMACEUTICAL INDUSTRIES, INC. FDA OTC

Use • treats frequent heartburn (occurs 2 or more days a week) • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Esomeprazole ESOMEPRAZOLE MAGNESIUM
YYBA CORP FDA OTC

Use treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM
CARDINAL HEALTH FDA OTC

Uses treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM
CHAIN DRUG MARKETING ASSOCIATION, INC. FDA OTC

Use(s) treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM
DR. REDDY'S LABORATORIES INC FDA OTC

Use(s) treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM
#20 20 mg Delayed-release
PROFICIENT RX LP FDA Rx Only

The active ingredient in the proton pump inhibitor Esomeprazole Magnesium Delayed-Release Capsules USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H -benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C 17 H 18 N 3 O 3 S) 2 Mg x 3 H 2 O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly cream or slightly yellow colored powder. It contains 3 moles of water of solvation and is soluble in methanol. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate USP) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, polysorbate 80, simethicone, sugar spheres, talc and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, titanium dioxide, ammonia solution, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide and shellac. Figure1

Esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM
#20 20 mg Delayed-release
RISING PHARMA HOLDINGS, INC. FDA Rx Only

The active ingredient in esomeprazole magnesium delayed-release capsules, USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy 3,5-dimethyl-2- pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C 17 H 18 N 3 O 3 S) 2 Mg x 3 H 2 O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each esomeprazole magnesium delayed-release capsule contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate) or 40 mg of esomeprazole (equivalent to 4.5 mg esomeprazole magnesium trihydrate) in the form of entericcoatedgranules with the following inactive ingredients: FD&C Blue #1, gelatin, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, methacrylic acid and ethyl acrylate copolymer, polysorbate 80, sodium bicarbonate, sodium lauryl sulfate, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, triethyl citrate, ferrosoferric oxide, potassium hydroxide, propylene glycol and shellac. esomeprazole-structure

Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM
#20 20 mg Delayed-release
ADVANCED RX OF TENNESSEE, LLC FDA Rx Only

The active ingredient in the esomeprazole magnesium delayed-release capsules, USP for oral administration is 1H-Benzimidazole, 5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl- 2-pyridinyl]methyl] Sulfinyl], Magnesium Salt (2:1) Trihydrate. Esomeprazole is S-enantiomer of omeprazole. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is C 34 H 36 MgN 6 O 6 S 2 .3H 2 O with molecular weight of 767.17 as a trihydrate. The structural formula is: Figure 1 The magnesium salt is a white to slightly colored powder. It contains 3 moles of water. Slightly soluble in methanol, insoluble in water and in n-Heptane. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. Esomeprazole magnesium is supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (equivalent to 22.25 mg esomeprazole magnesium trihydrate, USP) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate, USP) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hydroxy propyl cellulose, hypromellose, magnesium stearate, methacrylic acid ethyl acrylate copolymer, polysorbate 80, simethicone, sugar spheres (contains sucrose and starch), talc and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, titanium dioxide and sodium lauryl sulfate. The printing ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. Esomeprazolemagnesiumfigure1

Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM
THE KROGER CO. FDA OTC

Uses treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

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