{
"NDC": [
{
"NDCCode": "59651-562-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (59651-562-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK",
"NDC11Code": "59651-0562-78",
"ProductNDC": "59651-562",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20231120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205606",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231120",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1) , 2 Maintenance of healing of EE in adults. (1.2) , 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3) , 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4) , 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5) , 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6) .",
"Description": "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 (C17H18N3O3S)2 Mg x 3 H2O 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 powder. It contains 3 moles of water of solvation and is soluble in methanol, slightly soluble in water, practically insoluble in 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. 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 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: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion, mono and di glycerides, polysorbate 80, sugar spheres (which contains starch (maize) and sucrose), talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells contain gelatin and sodium lauryl sulfate. The capsule shells are imprinted with edible ink containing butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution and yellow iron oxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "12634-562-78",
"PackageDescription": "28 TABLET in 1 BOTTLE (12634-562-78)",
"NDC11Code": "12634-0562-78",
"ProductNDC": "12634-562",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate",
"NonProprietaryName": "Amlodipine Besylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140303",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203245",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "AMLODIPINE BESYLATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"IndicationAndUsage": "Amlodipine besylate tablets are calcium channel blockers and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of. Hypertension ( 1.1). o Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Coronary Artery Disease ( 1.2). o Chronic Stable Angina. o Vasospastic Angina (Prinzmetal's or Variant Angina). o Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.",
"Description": "Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl] 4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5 pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C 20H 25ClN 2O 5C 6H 6O 3S and its structural formula is:. Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate Tablets are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate."
},
{
"NDCCode": "46122-562-78",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (46122-562-78) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "46122-0562-78",
"ProductNDC": "46122-562",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204872",
"LabelerName": "Amerisource Bergen",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "220",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190201",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:headache muscular aches the common coldtoothache menstrual crampsbackacheminor pain of arthritis. temporarily reduces fever."
},
{
"NDCCode": "71205-562-78",
"PackageDescription": "180 TABLET in 1 BOTTLE (71205-562-78) ",
"NDC11Code": "71205-0562-78",
"ProductNDC": "71205-562",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hcl",
"NonProprietaryName": "Metformin Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090564",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260617",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin Hydrochloride Tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.",
"Description": "Metformin Hydrochloride Tablets USP are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Tablets USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients povidone (K-30), povidone (K-90), pregelatinized starch,and magnesium stearate. In addition, the coating for the tablets contains artificial blackberry flavor, hypromellose and polyethylene glycol."
},
{
"NDCCode": "59651-562-01",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-562-01) ",
"NDC11Code": "59651-0562-01",
"ProductNDC": "59651-562",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20231120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205606",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231120",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1) , 2 Maintenance of healing of EE in adults. (1.2) , 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3) , 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4) , 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5) , 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6) .",
"Description": "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 (C17H18N3O3S)2 Mg x 3 H2O 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 powder. It contains 3 moles of water of solvation and is soluble in methanol, slightly soluble in water, practically insoluble in 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. 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 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: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion, mono and di glycerides, polysorbate 80, sugar spheres (which contains starch (maize) and sucrose), talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells contain gelatin and sodium lauryl sulfate. The capsule shells are imprinted with edible ink containing butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution and yellow iron oxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "59651-562-25",
"PackageDescription": "25000 CAPSULE, DELAYED RELEASE in 1 BAG (59651-562-25) ",
"NDC11Code": "59651-0562-25",
"ProductNDC": "59651-562",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"StartMarketingDate": "20231120",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-12-28",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20-NOV-23"
},
{
"NDCCode": "59651-562-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-562-30) ",
"NDC11Code": "59651-0562-30",
"ProductNDC": "59651-562",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20231120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205606",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231120",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1) , 2 Maintenance of healing of EE in adults. (1.2) , 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3) , 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4) , 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5) , 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6) .",
"Description": "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 (C17H18N3O3S)2 Mg x 3 H2O 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 powder. It contains 3 moles of water of solvation and is soluble in methanol, slightly soluble in water, practically insoluble in 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. 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 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: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion, mono and di glycerides, polysorbate 80, sugar spheres (which contains starch (maize) and sucrose), talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells contain gelatin and sodium lauryl sulfate. The capsule shells are imprinted with edible ink containing butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution and yellow iron oxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "59651-562-90",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-562-90) ",
"NDC11Code": "59651-0562-90",
"ProductNDC": "59651-562",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20231120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205606",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231120",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1) , 2 Maintenance of healing of EE in adults. (1.2) , 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3) , 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4) , 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5) , 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6) .",
"Description": "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 (C17H18N3O3S)2 Mg x 3 H2O 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 powder. It contains 3 moles of water of solvation and is soluble in methanol, slightly soluble in water, practically insoluble in 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. 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 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: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion, mono and di glycerides, polysorbate 80, sugar spheres (which contains starch (maize) and sucrose), talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells contain gelatin and sodium lauryl sulfate. The capsule shells are imprinted with edible ink containing butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution and yellow iron oxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "59651-562-99",
"PackageDescription": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-562-99) ",
"NDC11Code": "59651-0562-99",
"ProductNDC": "59651-562",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20231120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205606",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231120",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1) , 2 Maintenance of healing of EE in adults. (1.2) , 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3) , 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4) , 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5) , 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6) .",
"Description": "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 (C17H18N3O3S)2 Mg x 3 H2O 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 powder. It contains 3 moles of water of solvation and is soluble in methanol, slightly soluble in water, practically insoluble in 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. 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 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: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion, mono and di glycerides, polysorbate 80, sugar spheres (which contains starch (maize) and sucrose), talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells contain gelatin and sodium lauryl sulfate. The capsule shells are imprinted with edible ink containing butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution and yellow iron oxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "59651-001-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (59651-001-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-001-10) ",
"NDC11Code": "59651-0001-78",
"ProductNDC": "59651-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203270",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150819",
"SamplePackage": "N",
"IndicationAndUsage": "Omeprazole is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4), 5 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6), 6 Pathologic hypersecretory conditions in adults (1.7).",
"Description": "The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole USP is a white to off-white powder that melts with decomposition between 150°C and 160°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: disodium hydrogen phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono and di-glycerides, polysorbate, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells also contain gelatin and iron oxide red. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2."
},
{
"NDCCode": "59651-002-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (59651-002-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-002-10) ",
"NDC11Code": "59651-0002-78",
"ProductNDC": "59651-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203270",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150819",
"SamplePackage": "N",
"IndicationAndUsage": "Omeprazole is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4), 5 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6), 6 Pathologic hypersecretory conditions in adults (1.7).",
"Description": "The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole USP is a white to off-white powder that melts with decomposition between 150°C and 160°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: disodium hydrogen phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono and di-glycerides, polysorbate, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells also contain gelatin and iron oxide red. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2."
},
{
"NDCCode": "59651-003-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (59651-003-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-003-10) ",
"NDC11Code": "59651-0003-78",
"ProductNDC": "59651-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203270",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150819",
"SamplePackage": "N",
"IndicationAndUsage": "Omeprazole is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4), 5 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6), 6 Pathologic hypersecretory conditions in adults (1.7).",
"Description": "The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole USP is a white to off-white powder that melts with decomposition between 150°C and 160°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: disodium hydrogen phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono and di-glycerides, polysorbate, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells also contain gelatin and iron oxide red. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2."
},
{
"NDCCode": "59651-279-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (59651-279-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-279-10) ",
"NDC11Code": "59651-0279-78",
"ProductNDC": "59651-279",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090778",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131211",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults and pediatric patients 13 years of age and older , 5 Chronic musculoskeletal pain in adults .",
"Description": "Duloxetine delayed-release capsules are selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include crospovidone, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, sugar spheres, talc, titanium dioxide, and triethylcitrate. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulphate. In addition, the 20 mg and 60 mg contain FD&C Blue No. 2 and iron oxide yellow and 30 mg contains FD&C Blue No. 2. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution."
},
{
"NDCCode": "59651-280-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (59651-280-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-280-10) ",
"NDC11Code": "59651-0280-78",
"ProductNDC": "59651-280",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090778",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131211",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults and pediatric patients 13 years of age and older , 5 Chronic musculoskeletal pain in adults .",
"Description": "Duloxetine delayed-release capsules are selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include crospovidone, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, sugar spheres, talc, titanium dioxide, and triethylcitrate. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulphate. In addition, the 20 mg and 60 mg contain FD&C Blue No. 2 and iron oxide yellow and 30 mg contains FD&C Blue No. 2. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution."
},
{
"NDCCode": "59651-282-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (59651-282-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-282-10) ",
"NDC11Code": "59651-0282-78",
"ProductNDC": "59651-282",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090778",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131211",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults and pediatric patients 13 years of age and older , 5 Chronic musculoskeletal pain in adults .",
"Description": "Duloxetine delayed-release capsules are selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include crospovidone, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, sugar spheres, talc, titanium dioxide, and triethylcitrate. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulphate. In addition, the 20 mg and 60 mg contain FD&C Blue No. 2 and iron oxide yellow and 30 mg contains FD&C Blue No. 2. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution."
},
{
"NDCCode": "59651-484-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (59651-484-78) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "59651-0484-78",
"ProductNDC": "59651-484",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215671",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211116",
"SamplePackage": "N",
"IndicationAndUsage": "Endocrine disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, nonsuppurative thyroiditis, hypercalcemia associated with cancer. Rheumatic disorders: as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis; posttraumatic osteoarthritis; synovitis of osteoarthritis; epicondylitis. Collagen diseases: during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus, acute rheumatic carditis. Dermatologic diseases: pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides, severe psoriasis, severe seborrheic dermatitis. Allergic states: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis, serum sickness, bronchial asthma, contact dermatitis, atopic dermatitis, drug hypersensitivity reactions. Ophthalmic diseases: severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as: allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, herpes zoster ophthalmicus, iritis and iridocyclitis, chorioretinitis, anterior segment inflammation, diffuse posterior uveitis and choroiditis, optic neuritis, sympathetic ophthalmia. Respiratory diseases: symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, aspiration pneumonitis. Hematologic disorders: idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous states: to induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal diseases: to tide the patient over a critical period of the disease in ulcerative colitis, regional enteritis. Miscellaneous: tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti-tuberculous chemotherapy, trichinosis with neurologic or myocardial involvement. In addition to the above indications, prednisone tablets are indicated for systemic dermatomyositis (polymyositis).",
"Description": "Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, that are readily absorbed from the gastrointestinal tract. The formula for prednisone is C21H26O5. Chemically, it is 17,21-dihydroxypregna-1,4-diene-3,11,20-trione and has the following structure. Prednisone USP is a white to partially white, odorless, crystalline powder and has a molecular weight of 358.43. It melts at about 230°C with some decomposition. Prednisone USP is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Prednisone tablets USP contain 1 mg prednisone, USP. The inactive ingredients for prednisone tablets USP include: D&C yellow No.10 aluminum lake, FD&C yellow # 6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. Meets USP Dissolution Test 2."
},
{
"NDCCode": "59651-485-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (59651-485-78) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "59651-0485-78",
"ProductNDC": "59651-485",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215672",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220328",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisone tablets are indicated in the following conditions. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia. Hypercalcemia associated with cancer. Nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional. treatment:. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of:. Leukemias and lymphomas in adults. Acute leukemia of childhood. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in:. Ulcerative colitis. Regional enteritis. Nervous System. Acute exacerbations of multiple sclerosis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.",
"Description": "Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below. C21H26O5 M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "59651-486-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (59651-486-78) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "59651-0486-78",
"ProductNDC": "59651-486",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215672",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220328",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisone tablets are indicated in the following conditions. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia. Hypercalcemia associated with cancer. Nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional. treatment:. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of:. Leukemias and lymphomas in adults. Acute leukemia of childhood. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in:. Ulcerative colitis. Regional enteritis. Nervous System. Acute exacerbations of multiple sclerosis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.",
"Description": "Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below. C21H26O5 M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "59651-487-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (59651-487-78) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "59651-0487-78",
"ProductNDC": "59651-487",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215672",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220328",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisone tablets are indicated in the following conditions. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia. Hypercalcemia associated with cancer. Nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional. treatment:. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of:. Leukemias and lymphomas in adults. Acute leukemia of childhood. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in:. Ulcerative colitis. Regional enteritis. Nervous System. Acute exacerbations of multiple sclerosis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.",
"Description": "Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below. C21H26O5 M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "59651-488-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (59651-488-78) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "59651-0488-78",
"ProductNDC": "59651-488",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215672",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220328",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisone tablets are indicated in the following conditions. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia. Hypercalcemia associated with cancer. Nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional. treatment:. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of:. Leukemias and lymphomas in adults. Acute leukemia of childhood. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in:. Ulcerative colitis. Regional enteritis. Nervous System. Acute exacerbations of multiple sclerosis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.",
"Description": "Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below. C21H26O5 M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "59651-489-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (59651-489-78) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "59651-0489-78",
"ProductNDC": "59651-489",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220328",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215672",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220328",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisone tablets are indicated in the following conditions. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia. Hypercalcemia associated with cancer. Nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional. treatment:. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of:. Leukemias and lymphomas in adults. Acute leukemia of childhood. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in:. Ulcerative colitis. Regional enteritis. Nervous System. Acute exacerbations of multiple sclerosis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.",
"Description": "Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below. C21H26O5 M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "59651-499-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (59651-499-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "59651-0499-78",
"ProductNDC": "59651-499",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Hydrochloride",
"NonProprietaryName": "Hydroxyzine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20211007",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087871",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "HYDROXYZINE DIHYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211007",
"SamplePackage": "N",
"IndicationAndUsage": "For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.",
"Description": "Hydroxyzine hydrochloride has the chemical name of 2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl] ethoxy] ethanol dihydrochloride. C21H27ClN2O22HCl Molecular Weight 447.83. Hydroxyzine hydrochloride USP occurs as a white powder which is very soluble in water.Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine hydrochloride USP. Inactive ingredients include FD&C blue #2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch (corn), and titanium dioxide. In addition, 10 mg contains D&C red #30 aluminum lake, 25 mg and 50 mg contains D&C red #7 calcium lake."
},
{
"NDCCode": "50458-562-01",
"PackageDescription": "1 SYRINGE in 1 KIT (50458-562-01) / .75 mL in 1 SYRINGE",
"NDC11Code": "50458-0562-01",
"ProductNDC": "50458-562",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Invega Sustenna",
"NonProprietaryName": "Paliperidone Palmitate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20090731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022264",
"LabelerName": "Janssen Pharmaceuticals, Inc.",
"SubstanceName": "PALIPERIDONE PALMITATE",
"StrengthNumber": "117",
"StrengthUnit": "mg/.75mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090731",
"SamplePackage": "N",
"IndicationAndUsage": "INVEGA SUSTENNA (paliperidone palmitate) is indicated for the treatment of: 1 Schizophrenia in adults [see Clinical Studies (14.1)]. , 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants [see Clinical Studies (14.2)]. .",
"Description": "INVEGA SUSTENNA ® contains paliperidone palmitate. The active ingredient, paliperidone, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. INVEGA SUSTENNA contains a racemic mixture of (+)- and (-)- paliperidone palmitate. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4 and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in polyethylene glycol 400 and propylene glycol, and slightly soluble in ethyl acetate. INVEGA SUSTENNA is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (and deliverable volumes) of the single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1.0 mL), and 234 mg (1.5 mL). The drug product hydrolyzes to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg of paliperidone, respectively. The inactive ingredients are polysorbate 20 (12 mg/mL), polyethylene glycol 4000 (30 mg/mL), citric acid monohydrate (5 mg/mL), disodium hydrogen phosphate anhydrous (5 mg/mL), sodium dihydrogen phosphate monohydrate (2.5 mg/mL), sodium hydroxide (2.84 mg/mL used as an alkalizing agent to set pH at 7), and water for injection. INVEGA SUSTENNA is provided in a single-dose prefilled syringe (cyclic-olefin-copolymer) with a plunger stopper and tip cap (bromobutyl rubber). The kit also contains 2 safety needles (a 1 ½-inch 22 gauge safety needle and a 1-inch 23 gauge safety needle)."
},
{
"NDCCode": "59651-844-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (59651-844-30) ",
"NDC11Code": "59651-0844-30",
"ProductNDC": "59651-844",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin",
"NonProprietaryName": "Doxepin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216041",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250712",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin tablets is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration.",
"Description": "Doxepin tablets are available in 3 mg and 6 mg strength tablets for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, equivalent to 3 mg and 6 mg of doxepin, respectively. Chemically, doxepin hydrochloride is an (E) and (Z) geometric, isomeric mixture of 1 propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-hydrochloride. It has the following structure. Doxepin hydrochloride, USP is a white crystalline powder, with a slight amine-like odor, that is readily soluble in water. It has a molecular weight of 315.84 and molecular formula of C19H21NOHCl. Each Doxepin tablet includes the following inactive ingredients: microcrystalline cellulose, magnesium stearate, pregelatinized starch, povidone."
},
{
"NDCCode": "59651-845-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (59651-845-30) ",
"NDC11Code": "59651-0845-30",
"ProductNDC": "59651-845",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin",
"NonProprietaryName": "Doxepin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216041",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250712",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin tablets is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration.",
"Description": "Doxepin tablets are available in 3 mg and 6 mg strength tablets for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, equivalent to 3 mg and 6 mg of doxepin, respectively. Chemically, doxepin hydrochloride is an (E) and (Z) geometric, isomeric mixture of 1 propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-hydrochloride. It has the following structure. Doxepin hydrochloride, USP is a white crystalline powder, with a slight amine-like odor, that is readily soluble in water. It has a molecular weight of 315.84 and molecular formula of C19H21NOHCl. Each Doxepin tablet includes the following inactive ingredients: microcrystalline cellulose, magnesium stearate, pregelatinized starch, povidone."
},
{
"NDCCode": "0597-0160-28",
"PackageDescription": "1 CARTRIDGE in 1 CARTON (0597-0160-28) / 28 SPRAY, METERED in 1 CARTRIDGE",
"NDC11Code": "00597-0160-28",
"ProductNDC": "0597-0160",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spiriva Respimat",
"NonProprietaryName": "Tiotropium Bromide Inhalation Spray",
"DosageFormName": "SPRAY, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20150915",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207070",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "TIOTROPIUM BROMIDE ANHYDROUS",
"StrengthNumber": "1.562",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150915",
"SamplePackage": "N",
"IndicationAndUsage": "SPIRIVA RESPIMAT is an anticholinergic indicated for: 1 The long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), and for reducing COPD exacerbations (1.1), 2 The long-term, once-daily, maintenance treatment of asthma in patients 6 years of age and older (1.2).",
"Description": "The active component of SPIRIVA RESPIMAT is tiotropium. The drug substance, tiotropium bromide monohydrate, is an anticholinergic with specificity for muscarinic receptors. It is chemically described as (1α, 2β, 4β, 5α, 7β)-7-[(Hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4] nonane bromide monohydrate. It is a synthetic, non-chiral, quaternary ammonium compound. Tiotropium bromide is a white or yellowish white powder. It is sparingly soluble in water and soluble in methanol. The structural formula is. Tiotropium bromide (monohydrate) has a molecular mass of 490.4 and a molecular formula of C19H22NO4S2Br ∙ H2O. The drug product, SPIRIVA RESPIMAT, is composed of a sterile, aqueous solution of tiotropium bromide filled into a 4.5 mL plastic container crimped into an aluminum cylinder (SPIRIVA RESPIMAT cartridge) for use with the SPIRIVA RESPIMAT inhaler. Excipients include benzalkonium chloride, edetate disodium, hydrochloric acid, and water for injection. The SPIRIVA RESPIMAT cartridge is only intended for use with the SPIRIVA RESPIMAT inhaler. The RESPIMAT inhaler is a hand held, pocket sized oral inhalation device that uses mechanical energy to generate a slow-moving aerosol cloud of medication from a metered volume of the drug solution. When used with the SPIRIVA RESPIMAT inhaler, each cartridge containing 4 grams of sterile aqueous solution delivers the labeled number of metered actuations after preparation for use. Each dose (one dose equals two actuations) from the SPIRIVA RESPIMAT inhaler delivers 2.5 mcg or 5 mcg of tiotropium (equivalent to 3.124 mcg or 6.247 mcg, respectively, of tiotropium bromide monohydrate) in 22.1 mcL from the mouthpiece. As with all inhaled drugs, the actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. The duration of inspiration should be at least as long as the spray duration (1.5 seconds). Prior to first use, the SPIRIVA RESPIMAT cartridge is inserted into the SPIRIVA RESPIMAT inhaler and the unit is primed. When using the unit for the first time, patients are to actuate the inhaler toward the ground until an aerosol cloud is visible and then repeat the process three more times. The unit is then considered primed and ready for use. If not used for more than 3 days, patients are to actuate the inhaler once to prepare the inhaler for use. If not used for more than 21 days, patients are to actuate the inhaler until an aerosol cloud is visible and then repeat the process three more times to prepare the inhaler for use [see Patient Counseling Information (17)]."
},
{
"NDCCode": "0597-0160-31",
"PackageDescription": "1 CARTRIDGE in 1 CARTON (0597-0160-31) > 28 SPRAY, METERED in 1 CARTRIDGE",
"NDC11Code": "00597-0160-31",
"ProductNDC": "0597-0160",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spiriva Respimat",
"NonProprietaryName": "Tiotropium Bromide Inhalation Spray",
"DosageFormName": "SPRAY, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20150915",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207070",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "TIOTROPIUM BROMIDE",
"StrengthNumber": "1.562",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-03-03"
},
{
"NDCCode": "0597-0160-61",
"PackageDescription": "1 CARTRIDGE in 1 CARTON (0597-0160-61) / 60 SPRAY, METERED in 1 CARTRIDGE",
"NDC11Code": "00597-0160-61",
"ProductNDC": "0597-0160",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spiriva Respimat",
"NonProprietaryName": "Tiotropium Bromide Inhalation Spray",
"DosageFormName": "SPRAY, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20150915",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207070",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "TIOTROPIUM BROMIDE ANHYDROUS",
"StrengthNumber": "1.562",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150915",
"SamplePackage": "N",
"IndicationAndUsage": "SPIRIVA RESPIMAT is an anticholinergic indicated for: 1 The long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), and for reducing COPD exacerbations (1.1), 2 The long-term, once-daily, maintenance treatment of asthma in patients 6 years of age and older (1.2).",
"Description": "The active component of SPIRIVA RESPIMAT is tiotropium. The drug substance, tiotropium bromide monohydrate, is an anticholinergic with specificity for muscarinic receptors. It is chemically described as (1α, 2β, 4β, 5α, 7β)-7-[(Hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4] nonane bromide monohydrate. It is a synthetic, non-chiral, quaternary ammonium compound. Tiotropium bromide is a white or yellowish white powder. It is sparingly soluble in water and soluble in methanol. The structural formula is. Tiotropium bromide (monohydrate) has a molecular mass of 490.4 and a molecular formula of C19H22NO4S2Br ∙ H2O. The drug product, SPIRIVA RESPIMAT, is composed of a sterile, aqueous solution of tiotropium bromide filled into a 4.5 mL plastic container crimped into an aluminum cylinder (SPIRIVA RESPIMAT cartridge) for use with the SPIRIVA RESPIMAT inhaler. Excipients include benzalkonium chloride, edetate disodium, hydrochloric acid, and water for injection. The SPIRIVA RESPIMAT cartridge is only intended for use with the SPIRIVA RESPIMAT inhaler. The RESPIMAT inhaler is a hand held, pocket sized oral inhalation device that uses mechanical energy to generate a slow-moving aerosol cloud of medication from a metered volume of the drug solution. When used with the SPIRIVA RESPIMAT inhaler, each cartridge containing 4 grams of sterile aqueous solution delivers the labeled number of metered actuations after preparation for use. Each dose (one dose equals two actuations) from the SPIRIVA RESPIMAT inhaler delivers 2.5 mcg or 5 mcg of tiotropium (equivalent to 3.124 mcg or 6.247 mcg, respectively, of tiotropium bromide monohydrate) in 22.1 mcL from the mouthpiece. As with all inhaled drugs, the actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. The duration of inspiration should be at least as long as the spray duration (1.5 seconds). Prior to first use, the SPIRIVA RESPIMAT cartridge is inserted into the SPIRIVA RESPIMAT inhaler and the unit is primed. When using the unit for the first time, patients are to actuate the inhaler toward the ground until an aerosol cloud is visible and then repeat the process three more times. The unit is then considered primed and ready for use. If not used for more than 3 days, patients are to actuate the inhaler once to prepare the inhaler for use. If not used for more than 21 days, patients are to actuate the inhaler until an aerosol cloud is visible and then repeat the process three more times to prepare the inhaler for use [see Patient Counseling Information (17)]."
},
{
"NDCCode": "0781-1943-39",
"PackageDescription": "40 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0781-1943-39) ",
"NDC11Code": "00781-1943-39",
"ProductNDC": "0781-1943",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET, MULTILAYER, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090227",
"LabelerName": "Sandoz Inc",
"SubstanceName": "AMOXICILLIN; AMOXICILLIN SODIUM; CLAVULANATE POTASSIUM",
"StrengthNumber": "562.5; 437.5; 62.5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillin-class Antibacterial [EPC], Penicillins [CS], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100421",
"SamplePackage": "N",
"IndicationAndUsage": "Amoxicillin and clavulanate potassium extended-release tablets is indicated for the treatment of infections in adults and pediatric patients weighing greater than or equal to 40 kg who are able to swallow tablets with: 1 community-acquired pneumonia or, 2 acute bacterial sinusitis.",
"Description": "Amoxicillin and clavulanate potassium extended-release tablets for oral use is an antibacterial combination consisting of the semisynthetic antibacterial amoxicillin (present as amoxicillin trihydrate and amoxicillin sodium) and the β-lactamase inhibitor clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin trihydrate molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Chemically, amoxicillin trihydrate is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3‑ dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. The amoxicillin sodium molecular formula is C16H18N3NaO5S, and the molecular weight is 387.39. Chemically, amoxicillin sodium is [2 -[2α,5α,6β(S*)]]-6-[[Amino(4‑ hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2‑ carboxylic acid monosodium salt and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β‑lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R,5R)-3-(2-hydroxy ethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate, and may be represented structurally as. Each tablet of amoxicillin and clavulanate potassium extended-release contains 1,000 mg of amoxicillin (437.5 mg as amoxicillin sodium and 562.5 mg as amoxicillin trihydrate), and 62.5 mg of clavulanic acid (equivalent to 74.5 mg of clavulanate potassium). Inactive Ingredients: Anhydrous citric acid, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, and xanthan gum. Each tablet of amoxicillin and clavulanate potassium extended-release tablets contains approximately 12 mg of potassium and 29 mg of sodium. Meets USP Dissolution Test 2."
},
{
"NDCCode": "0781-1943-82",
"PackageDescription": "28 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0781-1943-82) ",
"NDC11Code": "00781-1943-82",
"ProductNDC": "0781-1943",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET, MULTILAYER, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090227",
"LabelerName": "Sandoz Inc",
"SubstanceName": "AMOXICILLIN; AMOXICILLIN SODIUM; CLAVULANATE POTASSIUM",
"StrengthNumber": "562.5; 437.5; 62.5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillin-class Antibacterial [EPC], Penicillins [CS], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100421",
"SamplePackage": "N",
"IndicationAndUsage": "Amoxicillin and clavulanate potassium extended-release tablets is indicated for the treatment of infections in adults and pediatric patients weighing greater than or equal to 40 kg who are able to swallow tablets with: 1 community-acquired pneumonia or, 2 acute bacterial sinusitis.",
"Description": "Amoxicillin and clavulanate potassium extended-release tablets for oral use is an antibacterial combination consisting of the semisynthetic antibacterial amoxicillin (present as amoxicillin trihydrate and amoxicillin sodium) and the β-lactamase inhibitor clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin trihydrate molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Chemically, amoxicillin trihydrate is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3‑ dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. The amoxicillin sodium molecular formula is C16H18N3NaO5S, and the molecular weight is 387.39. Chemically, amoxicillin sodium is [2 -[2α,5α,6β(S*)]]-6-[[Amino(4‑ hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2‑ carboxylic acid monosodium salt and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β‑lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R,5R)-3-(2-hydroxy ethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate, and may be represented structurally as. Each tablet of amoxicillin and clavulanate potassium extended-release contains 1,000 mg of amoxicillin (437.5 mg as amoxicillin sodium and 562.5 mg as amoxicillin trihydrate), and 62.5 mg of clavulanic acid (equivalent to 74.5 mg of clavulanate potassium). Inactive Ingredients: Anhydrous citric acid, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, and xanthan gum. Each tablet of amoxicillin and clavulanate potassium extended-release tablets contains approximately 12 mg of potassium and 29 mg of sodium. Meets USP Dissolution Test 2."
}
]
}
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<NDCList>
<NDC>
<NDCCode>59651-562-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (59651-562-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59651-0562-78</NDC11Code>
<ProductNDC>59651-562</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205606</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1) , 2 Maintenance of healing of EE in adults. (1.2) , 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3) , 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4) , 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5) , 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6) .</IndicationAndUsage>
<Description>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 (C17H18N3O3S)2 Mg x 3 H2O 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 powder. It contains 3 moles of water of solvation and is soluble in methanol, slightly soluble in water, practically insoluble in 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. 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 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: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion, mono and di glycerides, polysorbate 80, sugar spheres (which contains starch (maize) and sucrose), talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells contain gelatin and sodium lauryl sulfate. The capsule shells are imprinted with edible ink containing butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution and yellow iron oxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>12634-562-78</NDCCode>
<PackageDescription>28 TABLET in 1 BOTTLE (12634-562-78)</PackageDescription>
<NDC11Code>12634-0562-78</NDC11Code>
<ProductNDC>12634-562</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140303</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203245</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Amlodipine besylate tablets are calcium channel blockers and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of. Hypertension ( 1.1). o Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Coronary Artery Disease ( 1.2). o Chronic Stable Angina. o Vasospastic Angina (Prinzmetal's or Variant Angina). o Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.</IndicationAndUsage>
<Description>Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl] 4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5 pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C 20H 25ClN 2O 5C 6H 6O 3S and its structural formula is:. Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate Tablets are formulated as white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>46122-562-78</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (46122-562-78) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>46122-0562-78</NDC11Code>
<ProductNDC>46122-562</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204872</ApplicationNumber>
<LabelerName>Amerisource Bergen</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>220</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to:headache muscular aches the common coldtoothache menstrual crampsbackacheminor pain of arthritis. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71205-562-78</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (71205-562-78) </PackageDescription>
<NDC11Code>71205-0562-78</NDC11Code>
<ProductNDC>71205-562</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hcl</ProprietaryName>
<NonProprietaryName>Metformin Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090564</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260617</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin Hydrochloride Tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin Hydrochloride Tablets USP are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Tablets USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients povidone (K-30), povidone (K-90), pregelatinized starch,and magnesium stearate. In addition, the coating for the tablets contains artificial blackberry flavor, hypromellose and polyethylene glycol.</Description>
</NDC>
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<ApplicationNumber>ANDA205606</ApplicationNumber>
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<IndicationAndUsage>Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1) , 2 Maintenance of healing of EE in adults. (1.2) , 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3) , 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4) , 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5) , 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6) .</IndicationAndUsage>
<Description>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 (C17H18N3O3S)2 Mg x 3 H2O 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 powder. It contains 3 moles of water of solvation and is soluble in methanol, slightly soluble in water, practically insoluble in 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. 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 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: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion, mono and di glycerides, polysorbate 80, sugar spheres (which contains starch (maize) and sucrose), talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells contain gelatin and sodium lauryl sulfate. The capsule shells are imprinted with edible ink containing butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution and yellow iron oxide. Meets USP Dissolution Test 2.</Description>
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<LastUpdate>2024-12-28</LastUpdate>
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<StartMarketingDatePackage>20-NOV-23</StartMarketingDatePackage>
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<IndicationAndUsage>Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1) , 2 Maintenance of healing of EE in adults. (1.2) , 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3) , 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4) , 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5) , 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6) .</IndicationAndUsage>
<Description>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 (C17H18N3O3S)2 Mg x 3 H2O 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 powder. It contains 3 moles of water of solvation and is soluble in methanol, slightly soluble in water, practically insoluble in 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. 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 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: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion, mono and di glycerides, polysorbate 80, sugar spheres (which contains starch (maize) and sucrose), talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells contain gelatin and sodium lauryl sulfate. The capsule shells are imprinted with edible ink containing butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution and yellow iron oxide. Meets USP Dissolution Test 2.</Description>
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<IndicationAndUsage>Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1) , 2 Maintenance of healing of EE in adults. (1.2) , 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3) , 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4) , 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5) , 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6) .</IndicationAndUsage>
<Description>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 (C17H18N3O3S)2 Mg x 3 H2O 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 powder. It contains 3 moles of water of solvation and is soluble in methanol, slightly soluble in water, practically insoluble in 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. 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 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: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion, mono and di glycerides, polysorbate 80, sugar spheres (which contains starch (maize) and sucrose), talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells contain gelatin and sodium lauryl sulfate. The capsule shells are imprinted with edible ink containing butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution and yellow iron oxide. Meets USP Dissolution Test 2.</Description>
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<IndicationAndUsage>Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1) , 2 Maintenance of healing of EE in adults. (1.2) , 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3) , 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4) , 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5) , 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6) .</IndicationAndUsage>
<Description>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 (C17H18N3O3S)2 Mg x 3 H2O 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 powder. It contains 3 moles of water of solvation and is soluble in methanol, slightly soluble in water, practically insoluble in 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. 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 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: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion, mono and di glycerides, polysorbate 80, sugar spheres (which contains starch (maize) and sucrose), talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells contain gelatin and sodium lauryl sulfate. The capsule shells are imprinted with edible ink containing butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution and yellow iron oxide. Meets USP Dissolution Test 2.</Description>
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<IndicationAndUsage>Omeprazole is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4), 5 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6), 6 Pathologic hypersecretory conditions in adults (1.7).</IndicationAndUsage>
<Description>The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole USP is a white to off-white powder that melts with decomposition between 150°C and 160°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: disodium hydrogen phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono and di-glycerides, polysorbate, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells also contain gelatin and iron oxide red. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2.</Description>
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<IndicationAndUsage>Omeprazole is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4), 5 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6), 6 Pathologic hypersecretory conditions in adults (1.7).</IndicationAndUsage>
<Description>The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole USP is a white to off-white powder that melts with decomposition between 150°C and 160°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: disodium hydrogen phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono and di-glycerides, polysorbate, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells also contain gelatin and iron oxide red. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2.</Description>
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<IndicationAndUsage>Omeprazole is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1), 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2), 3 Treatment of active benign gastric ulcer in adults (1.3), 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4), 5 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6), 6 Pathologic hypersecretory conditions in adults (1.7).</IndicationAndUsage>
<Description>The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:. Omeprazole USP is a white to off-white powder that melts with decomposition between 150°C and 160°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: disodium hydrogen phosphate dihydrate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, mono and di-glycerides, polysorbate, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate. In addition, the empty hard gelatin capsule shells also contain gelatin and iron oxide red. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2.</Description>
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<PackageDescription>10 BLISTER PACK in 1 CARTON (59651-279-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-279-10) </PackageDescription>
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<ApplicationNumber>ANDA090778</ApplicationNumber>
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<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults and pediatric patients 13 years of age and older , 5 Chronic musculoskeletal pain in adults .</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules are selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include crospovidone, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, sugar spheres, talc, titanium dioxide, and triethylcitrate. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulphate. In addition, the 20 mg and 60 mg contain FD&C Blue No. 2 and iron oxide yellow and 30 mg contains FD&C Blue No. 2. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.</Description>
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<PackageDescription>10 BLISTER PACK in 1 CARTON (59651-280-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-280-10) </PackageDescription>
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<ApplicationNumber>ANDA090778</ApplicationNumber>
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<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
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<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults and pediatric patients 13 years of age and older , 5 Chronic musculoskeletal pain in adults .</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules are selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include crospovidone, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, sugar spheres, talc, titanium dioxide, and triethylcitrate. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulphate. In addition, the 20 mg and 60 mg contain FD&C Blue No. 2 and iron oxide yellow and 30 mg contains FD&C Blue No. 2. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.</Description>
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<PackageDescription>10 BLISTER PACK in 1 CARTON (59651-282-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-282-10) </PackageDescription>
<NDC11Code>59651-0282-78</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine</ProprietaryName>
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<ApplicationNumber>ANDA090778</ApplicationNumber>
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<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
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<LastUpdate>2024-12-27</LastUpdate>
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<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults and pediatric patients 13 years of age and older , 5 Chronic musculoskeletal pain in adults .</IndicationAndUsage>
<Description>Duloxetine delayed-release capsules are selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include crospovidone, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, sugar spheres, talc, titanium dioxide, and triethylcitrate. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulphate. In addition, the 20 mg and 60 mg contain FD&C Blue No. 2 and iron oxide yellow and 30 mg contains FD&C Blue No. 2. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.</Description>
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<PackageDescription>10 BLISTER PACK in 1 CARTON (59651-484-78) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59651-0484-78</NDC11Code>
<ProductNDC>59651-484</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20211116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215671</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-01</LastUpdate>
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<IndicationAndUsage>Endocrine disorders: primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, nonsuppurative thyroiditis, hypercalcemia associated with cancer. Rheumatic disorders: as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis; posttraumatic osteoarthritis; synovitis of osteoarthritis; epicondylitis. Collagen diseases: during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus, acute rheumatic carditis. Dermatologic diseases: pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides, severe psoriasis, severe seborrheic dermatitis. Allergic states: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis, serum sickness, bronchial asthma, contact dermatitis, atopic dermatitis, drug hypersensitivity reactions. Ophthalmic diseases: severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as: allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, herpes zoster ophthalmicus, iritis and iridocyclitis, chorioretinitis, anterior segment inflammation, diffuse posterior uveitis and choroiditis, optic neuritis, sympathetic ophthalmia. Respiratory diseases: symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, aspiration pneumonitis. Hematologic disorders: idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous states: to induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal diseases: to tide the patient over a critical period of the disease in ulcerative colitis, regional enteritis. Miscellaneous: tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti-tuberculous chemotherapy, trichinosis with neurologic or myocardial involvement. In addition to the above indications, prednisone tablets are indicated for systemic dermatomyositis (polymyositis).</IndicationAndUsage>
<Description>Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, that are readily absorbed from the gastrointestinal tract. The formula for prednisone is C21H26O5. Chemically, it is 17,21-dihydroxypregna-1,4-diene-3,11,20-trione and has the following structure. Prednisone USP is a white to partially white, odorless, crystalline powder and has a molecular weight of 358.43. It melts at about 230°C with some decomposition. Prednisone USP is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Prednisone tablets USP contain 1 mg prednisone, USP. The inactive ingredients for prednisone tablets USP include: D&C yellow No.10 aluminum lake, FD&C yellow # 6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. Meets USP Dissolution Test 2.</Description>
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<NDCCode>59651-485-78</NDCCode>
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<ApplicationNumber>ANDA215672</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
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<LastUpdate>2024-02-27</LastUpdate>
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<IndicationAndUsage>Prednisone tablets are indicated in the following conditions. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia. Hypercalcemia associated with cancer. Nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional. treatment:. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of:. Leukemias and lymphomas in adults. Acute leukemia of childhood. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in:. Ulcerative colitis. Regional enteritis. Nervous System. Acute exacerbations of multiple sclerosis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below. C21H26O5 M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP.</Description>
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<NDCCode>59651-486-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (59651-486-78) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
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<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
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<IndicationAndUsage>Prednisone tablets are indicated in the following conditions. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia. Hypercalcemia associated with cancer. Nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional. treatment:. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of:. Leukemias and lymphomas in adults. Acute leukemia of childhood. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in:. Ulcerative colitis. Regional enteritis. Nervous System. Acute exacerbations of multiple sclerosis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below. C21H26O5 M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP.</Description>
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<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
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<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
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<IndicationAndUsage>Prednisone tablets are indicated in the following conditions. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia. Hypercalcemia associated with cancer. Nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional. treatment:. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of:. Leukemias and lymphomas in adults. Acute leukemia of childhood. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in:. Ulcerative colitis. Regional enteritis. Nervous System. Acute exacerbations of multiple sclerosis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below. C21H26O5 M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>59651-488-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (59651-488-78) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59651-0488-78</NDC11Code>
<ProductNDC>59651-488</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220328</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215672</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prednisone tablets are indicated in the following conditions. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia. Hypercalcemia associated with cancer. Nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional. treatment:. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of:. Leukemias and lymphomas in adults. Acute leukemia of childhood. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in:. Ulcerative colitis. Regional enteritis. Nervous System. Acute exacerbations of multiple sclerosis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below. C21H26O5 M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>59651-489-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (59651-489-78) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59651-0489-78</NDC11Code>
<ProductNDC>59651-489</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220328</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215672</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prednisone tablets are indicated in the following conditions. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia. Hypercalcemia associated with cancer. Nonsuppurative thyroiditis. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional. treatment:. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia. Allergic conjunctivitis. Keratitis. Chorioretinitis. Optic neuritis. Iritis and iridocyclitis. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. Neoplastic Diseases. For palliative management of:. Leukemias and lymphomas in adults. Acute leukemia of childhood. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in:. Ulcerative colitis. Regional enteritis. Nervous System. Acute exacerbations of multiple sclerosis. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake. Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below. C21H26O5 M.W. 358.44 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>59651-499-78</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (59651-499-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59651-0499-78</NDC11Code>
<ProductNDC>59651-499</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211007</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087871</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>HYDROXYZINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Hydroxyzine hydrochloride has the chemical name of 2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl] ethoxy] ethanol dihydrochloride. C21H27ClN2O22HCl Molecular Weight 447.83. Hydroxyzine hydrochloride USP occurs as a white powder which is very soluble in water.Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine hydrochloride USP. Inactive ingredients include FD&C blue #2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch (corn), and titanium dioxide. In addition, 10 mg contains D&C red #30 aluminum lake, 25 mg and 50 mg contains D&C red #7 calcium lake.</Description>
</NDC>
<NDC>
<NDCCode>50458-562-01</NDCCode>
<PackageDescription>1 SYRINGE in 1 KIT (50458-562-01) / .75 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>50458-0562-01</NDC11Code>
<ProductNDC>50458-562</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Invega Sustenna</ProprietaryName>
<NonProprietaryName>Paliperidone Palmitate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20090731</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022264</ApplicationNumber>
<LabelerName>Janssen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PALIPERIDONE PALMITATE</SubstanceName>
<StrengthNumber>117</StrengthNumber>
<StrengthUnit>mg/.75mL</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INVEGA SUSTENNA (paliperidone palmitate) is indicated for the treatment of: 1 Schizophrenia in adults [see Clinical Studies (14.1)]. , 2 Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants [see Clinical Studies (14.2)]. .</IndicationAndUsage>
<Description>INVEGA SUSTENNA ® contains paliperidone palmitate. The active ingredient, paliperidone, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. INVEGA SUSTENNA contains a racemic mixture of (+)- and (-)- paliperidone palmitate. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-4-oxo-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimadin-9-yl hexadecanoate. Its molecular formula is C 39H 57FN 4O 4 and its molecular weight is 664.89. The structural formula is:. Paliperidone palmitate is very slightly soluble in ethanol and methanol, practically insoluble in polyethylene glycol 400 and propylene glycol, and slightly soluble in ethyl acetate. INVEGA SUSTENNA is available as a white to off-white sterile aqueous extended-release suspension for intramuscular injection in the following dose strengths of paliperidone palmitate (and deliverable volumes) of the single-dose prefilled syringes: 39 mg (0.25 mL), 78 mg (0.5 mL), 117 mg (0.75 mL), 156 mg (1.0 mL), and 234 mg (1.5 mL). The drug product hydrolyzes to the active moiety, paliperidone, resulting in dose strengths of 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg of paliperidone, respectively. The inactive ingredients are polysorbate 20 (12 mg/mL), polyethylene glycol 4000 (30 mg/mL), citric acid monohydrate (5 mg/mL), disodium hydrogen phosphate anhydrous (5 mg/mL), sodium dihydrogen phosphate monohydrate (2.5 mg/mL), sodium hydroxide (2.84 mg/mL used as an alkalizing agent to set pH at 7), and water for injection. INVEGA SUSTENNA is provided in a single-dose prefilled syringe (cyclic-olefin-copolymer) with a plunger stopper and tip cap (bromobutyl rubber). The kit also contains 2 safety needles (a 1 ½-inch 22 gauge safety needle and a 1-inch 23 gauge safety needle).</Description>
</NDC>
<NDC>
<NDCCode>59651-844-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (59651-844-30) </PackageDescription>
<NDC11Code>59651-0844-30</NDC11Code>
<ProductNDC>59651-844</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin</ProprietaryName>
<NonProprietaryName>Doxepin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216041</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin tablets is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration.</IndicationAndUsage>
<Description>Doxepin tablets are available in 3 mg and 6 mg strength tablets for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, equivalent to 3 mg and 6 mg of doxepin, respectively. Chemically, doxepin hydrochloride is an (E) and (Z) geometric, isomeric mixture of 1 propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-hydrochloride. It has the following structure. Doxepin hydrochloride, USP is a white crystalline powder, with a slight amine-like odor, that is readily soluble in water. It has a molecular weight of 315.84 and molecular formula of C19H21NOHCl. Each Doxepin tablet includes the following inactive ingredients: microcrystalline cellulose, magnesium stearate, pregelatinized starch, povidone.</Description>
</NDC>
<NDC>
<NDCCode>59651-845-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (59651-845-30) </PackageDescription>
<NDC11Code>59651-0845-30</NDC11Code>
<ProductNDC>59651-845</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin</ProprietaryName>
<NonProprietaryName>Doxepin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216041</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin tablets is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration.</IndicationAndUsage>
<Description>Doxepin tablets are available in 3 mg and 6 mg strength tablets for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, equivalent to 3 mg and 6 mg of doxepin, respectively. Chemically, doxepin hydrochloride is an (E) and (Z) geometric, isomeric mixture of 1 propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-hydrochloride. It has the following structure. Doxepin hydrochloride, USP is a white crystalline powder, with a slight amine-like odor, that is readily soluble in water. It has a molecular weight of 315.84 and molecular formula of C19H21NOHCl. Each Doxepin tablet includes the following inactive ingredients: microcrystalline cellulose, magnesium stearate, pregelatinized starch, povidone.</Description>
</NDC>
<NDC>
<NDCCode>0597-0160-28</NDCCode>
<PackageDescription>1 CARTRIDGE in 1 CARTON (0597-0160-28) / 28 SPRAY, METERED in 1 CARTRIDGE</PackageDescription>
<NDC11Code>00597-0160-28</NDC11Code>
<ProductNDC>0597-0160</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spiriva Respimat</ProprietaryName>
<NonProprietaryName>Tiotropium Bromide Inhalation Spray</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20150915</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207070</ApplicationNumber>
<LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TIOTROPIUM BROMIDE ANHYDROUS</SubstanceName>
<StrengthNumber>1.562</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SPIRIVA RESPIMAT is an anticholinergic indicated for: 1 The long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), and for reducing COPD exacerbations (1.1), 2 The long-term, once-daily, maintenance treatment of asthma in patients 6 years of age and older (1.2).</IndicationAndUsage>
<Description>The active component of SPIRIVA RESPIMAT is tiotropium. The drug substance, tiotropium bromide monohydrate, is an anticholinergic with specificity for muscarinic receptors. It is chemically described as (1α, 2β, 4β, 5α, 7β)-7-[(Hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4] nonane bromide monohydrate. It is a synthetic, non-chiral, quaternary ammonium compound. Tiotropium bromide is a white or yellowish white powder. It is sparingly soluble in water and soluble in methanol. The structural formula is. Tiotropium bromide (monohydrate) has a molecular mass of 490.4 and a molecular formula of C19H22NO4S2Br ∙ H2O. The drug product, SPIRIVA RESPIMAT, is composed of a sterile, aqueous solution of tiotropium bromide filled into a 4.5 mL plastic container crimped into an aluminum cylinder (SPIRIVA RESPIMAT cartridge) for use with the SPIRIVA RESPIMAT inhaler. Excipients include benzalkonium chloride, edetate disodium, hydrochloric acid, and water for injection. The SPIRIVA RESPIMAT cartridge is only intended for use with the SPIRIVA RESPIMAT inhaler. The RESPIMAT inhaler is a hand held, pocket sized oral inhalation device that uses mechanical energy to generate a slow-moving aerosol cloud of medication from a metered volume of the drug solution. When used with the SPIRIVA RESPIMAT inhaler, each cartridge containing 4 grams of sterile aqueous solution delivers the labeled number of metered actuations after preparation for use. Each dose (one dose equals two actuations) from the SPIRIVA RESPIMAT inhaler delivers 2.5 mcg or 5 mcg of tiotropium (equivalent to 3.124 mcg or 6.247 mcg, respectively, of tiotropium bromide monohydrate) in 22.1 mcL from the mouthpiece. As with all inhaled drugs, the actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. The duration of inspiration should be at least as long as the spray duration (1.5 seconds). Prior to first use, the SPIRIVA RESPIMAT cartridge is inserted into the SPIRIVA RESPIMAT inhaler and the unit is primed. When using the unit for the first time, patients are to actuate the inhaler toward the ground until an aerosol cloud is visible and then repeat the process three more times. The unit is then considered primed and ready for use. If not used for more than 3 days, patients are to actuate the inhaler once to prepare the inhaler for use. If not used for more than 21 days, patients are to actuate the inhaler until an aerosol cloud is visible and then repeat the process three more times to prepare the inhaler for use [see Patient Counseling Information (17)].</Description>
</NDC>
<NDC>
<NDCCode>0597-0160-31</NDCCode>
<PackageDescription>1 CARTRIDGE in 1 CARTON (0597-0160-31) > 28 SPRAY, METERED in 1 CARTRIDGE</PackageDescription>
<NDC11Code>00597-0160-31</NDC11Code>
<ProductNDC>0597-0160</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spiriva Respimat</ProprietaryName>
<NonProprietaryName>Tiotropium Bromide Inhalation Spray</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20150915</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207070</ApplicationNumber>
<LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TIOTROPIUM BROMIDE</SubstanceName>
<StrengthNumber>1.562</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-03-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>0597-0160-61</NDCCode>
<PackageDescription>1 CARTRIDGE in 1 CARTON (0597-0160-61) / 60 SPRAY, METERED in 1 CARTRIDGE</PackageDescription>
<NDC11Code>00597-0160-61</NDC11Code>
<ProductNDC>0597-0160</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spiriva Respimat</ProprietaryName>
<NonProprietaryName>Tiotropium Bromide Inhalation Spray</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20150915</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207070</ApplicationNumber>
<LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TIOTROPIUM BROMIDE ANHYDROUS</SubstanceName>
<StrengthNumber>1.562</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SPIRIVA RESPIMAT is an anticholinergic indicated for: 1 The long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), and for reducing COPD exacerbations (1.1), 2 The long-term, once-daily, maintenance treatment of asthma in patients 6 years of age and older (1.2).</IndicationAndUsage>
<Description>The active component of SPIRIVA RESPIMAT is tiotropium. The drug substance, tiotropium bromide monohydrate, is an anticholinergic with specificity for muscarinic receptors. It is chemically described as (1α, 2β, 4β, 5α, 7β)-7-[(Hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4] nonane bromide monohydrate. It is a synthetic, non-chiral, quaternary ammonium compound. Tiotropium bromide is a white or yellowish white powder. It is sparingly soluble in water and soluble in methanol. The structural formula is. Tiotropium bromide (monohydrate) has a molecular mass of 490.4 and a molecular formula of C19H22NO4S2Br ∙ H2O. The drug product, SPIRIVA RESPIMAT, is composed of a sterile, aqueous solution of tiotropium bromide filled into a 4.5 mL plastic container crimped into an aluminum cylinder (SPIRIVA RESPIMAT cartridge) for use with the SPIRIVA RESPIMAT inhaler. Excipients include benzalkonium chloride, edetate disodium, hydrochloric acid, and water for injection. The SPIRIVA RESPIMAT cartridge is only intended for use with the SPIRIVA RESPIMAT inhaler. The RESPIMAT inhaler is a hand held, pocket sized oral inhalation device that uses mechanical energy to generate a slow-moving aerosol cloud of medication from a metered volume of the drug solution. When used with the SPIRIVA RESPIMAT inhaler, each cartridge containing 4 grams of sterile aqueous solution delivers the labeled number of metered actuations after preparation for use. Each dose (one dose equals two actuations) from the SPIRIVA RESPIMAT inhaler delivers 2.5 mcg or 5 mcg of tiotropium (equivalent to 3.124 mcg or 6.247 mcg, respectively, of tiotropium bromide monohydrate) in 22.1 mcL from the mouthpiece. As with all inhaled drugs, the actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. The duration of inspiration should be at least as long as the spray duration (1.5 seconds). Prior to first use, the SPIRIVA RESPIMAT cartridge is inserted into the SPIRIVA RESPIMAT inhaler and the unit is primed. When using the unit for the first time, patients are to actuate the inhaler toward the ground until an aerosol cloud is visible and then repeat the process three more times. The unit is then considered primed and ready for use. If not used for more than 3 days, patients are to actuate the inhaler once to prepare the inhaler for use. If not used for more than 21 days, patients are to actuate the inhaler until an aerosol cloud is visible and then repeat the process three more times to prepare the inhaler for use [see Patient Counseling Information (17)].</Description>
</NDC>
<NDC>
<NDCCode>0781-1943-39</NDCCode>
<PackageDescription>40 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0781-1943-39) </PackageDescription>
<NDC11Code>00781-1943-39</NDC11Code>
<ProductNDC>0781-1943</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>TABLET, MULTILAYER, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100421</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090227</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>AMOXICILLIN; AMOXICILLIN SODIUM; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>562.5; 437.5; 62.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillin-class Antibacterial [EPC], Penicillins [CS], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100421</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amoxicillin and clavulanate potassium extended-release tablets is indicated for the treatment of infections in adults and pediatric patients weighing greater than or equal to 40 kg who are able to swallow tablets with: 1 community-acquired pneumonia or, 2 acute bacterial sinusitis.</IndicationAndUsage>
<Description>Amoxicillin and clavulanate potassium extended-release tablets for oral use is an antibacterial combination consisting of the semisynthetic antibacterial amoxicillin (present as amoxicillin trihydrate and amoxicillin sodium) and the β-lactamase inhibitor clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin trihydrate molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Chemically, amoxicillin trihydrate is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3‑ dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. The amoxicillin sodium molecular formula is C16H18N3NaO5S, and the molecular weight is 387.39. Chemically, amoxicillin sodium is [2 -[2α,5α,6β(S*)]]-6-[[Amino(4‑ hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2‑ carboxylic acid monosodium salt and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β‑lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R,5R)-3-(2-hydroxy ethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate, and may be represented structurally as. Each tablet of amoxicillin and clavulanate potassium extended-release contains 1,000 mg of amoxicillin (437.5 mg as amoxicillin sodium and 562.5 mg as amoxicillin trihydrate), and 62.5 mg of clavulanic acid (equivalent to 74.5 mg of clavulanate potassium). Inactive Ingredients: Anhydrous citric acid, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, and xanthan gum. Each tablet of amoxicillin and clavulanate potassium extended-release tablets contains approximately 12 mg of potassium and 29 mg of sodium. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>0781-1943-82</NDCCode>
<PackageDescription>28 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0781-1943-82) </PackageDescription>
<NDC11Code>00781-1943-82</NDC11Code>
<ProductNDC>0781-1943</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>TABLET, MULTILAYER, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100421</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090227</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>AMOXICILLIN; AMOXICILLIN SODIUM; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>562.5; 437.5; 62.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillin-class Antibacterial [EPC], Penicillins [CS], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100421</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amoxicillin and clavulanate potassium extended-release tablets is indicated for the treatment of infections in adults and pediatric patients weighing greater than or equal to 40 kg who are able to swallow tablets with: 1 community-acquired pneumonia or, 2 acute bacterial sinusitis.</IndicationAndUsage>
<Description>Amoxicillin and clavulanate potassium extended-release tablets for oral use is an antibacterial combination consisting of the semisynthetic antibacterial amoxicillin (present as amoxicillin trihydrate and amoxicillin sodium) and the β-lactamase inhibitor clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin trihydrate molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Chemically, amoxicillin trihydrate is (2S,5R,6R)-6-[(R)-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3‑ dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as. The amoxicillin sodium molecular formula is C16H18N3NaO5S, and the molecular weight is 387.39. Chemically, amoxicillin sodium is [2 -[2α,5α,6β(S*)]]-6-[[Amino(4‑ hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2‑ carboxylic acid monosodium salt and may be represented structurally as. Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a β‑lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated β-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2R,5R)-3-(2-hydroxy ethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate, and may be represented structurally as. Each tablet of amoxicillin and clavulanate potassium extended-release contains 1,000 mg of amoxicillin (437.5 mg as amoxicillin sodium and 562.5 mg as amoxicillin trihydrate), and 62.5 mg of clavulanic acid (equivalent to 74.5 mg of clavulanate potassium). Inactive Ingredients: Anhydrous citric acid, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, and xanthan gum. Each tablet of amoxicillin and clavulanate potassium extended-release tablets contains approximately 12 mg of potassium and 29 mg of sodium. Meets USP Dissolution Test 2.</Description>
</NDC>
</NDCList>