{
"NDC": [
{
"NDCCode": "64679-670-02",
"PackageDescription": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64679-670-02) ",
"NDC11Code": "64679-0670-02",
"ProductNDC": "64679-670",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202176",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20120914",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules, USP are proton pump inhibitors (PPIs) indicated for the: : 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).",
"Description": "The active ingredient in lansoprazole delayed-release capsule, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole, USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsules for oral administration. The lansoprazole delayed-release capsules, USP are available in two dosage strengths: 15 and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients for 15 and 30 mg: colloidal silicon dioxide, D&C Red 33, FD&C Blue 1, gelatin, hypromellose, iron oxide black, magnesium carbonate, methacrylic acid co-polymer dispersion, polyethylene glycol, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sucrose, sugar sphere, talc, titanium dioxide. In addition 15 mg capsule only: D&C Yellow 10."
},
{
"NDCCode": "64679-670-01",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64679-670-01) ",
"NDC11Code": "64679-0670-01",
"ProductNDC": "64679-670",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202176",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20120914",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules, USP are proton pump inhibitors (PPIs) indicated for the: : 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).",
"Description": "The active ingredient in lansoprazole delayed-release capsule, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole, USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsules for oral administration. The lansoprazole delayed-release capsules, USP are available in two dosage strengths: 15 and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients for 15 and 30 mg: colloidal silicon dioxide, D&C Red 33, FD&C Blue 1, gelatin, hypromellose, iron oxide black, magnesium carbonate, methacrylic acid co-polymer dispersion, polyethylene glycol, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sucrose, sugar sphere, talc, titanium dioxide. In addition 15 mg capsule only: D&C Yellow 10."
},
{
"NDCCode": "64679-670-03",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64679-670-03) ",
"NDC11Code": "64679-0670-03",
"ProductNDC": "64679-670",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202176",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20120914",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules, USP are proton pump inhibitors (PPIs) indicated for the: : 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).",
"Description": "The active ingredient in lansoprazole delayed-release capsule, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole, USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsules for oral administration. The lansoprazole delayed-release capsules, USP are available in two dosage strengths: 15 and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients for 15 and 30 mg: colloidal silicon dioxide, D&C Red 33, FD&C Blue 1, gelatin, hypromellose, iron oxide black, magnesium carbonate, methacrylic acid co-polymer dispersion, polyethylene glycol, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sucrose, sugar sphere, talc, titanium dioxide. In addition 15 mg capsule only: D&C Yellow 10."
},
{
"NDCCode": "64679-670-04",
"PackageDescription": "500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64679-670-04) ",
"NDC11Code": "64679-0670-04",
"ProductNDC": "64679-670",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202176",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20120914",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules, USP are proton pump inhibitors (PPIs) indicated for the: : 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).",
"Description": "The active ingredient in lansoprazole delayed-release capsule, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole, USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsules for oral administration. The lansoprazole delayed-release capsules, USP are available in two dosage strengths: 15 and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients for 15 and 30 mg: colloidal silicon dioxide, D&C Red 33, FD&C Blue 1, gelatin, hypromellose, iron oxide black, magnesium carbonate, methacrylic acid co-polymer dispersion, polyethylene glycol, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sucrose, sugar sphere, talc, titanium dioxide. In addition 15 mg capsule only: D&C Yellow 10."
},
{
"NDCCode": "64679-670-05",
"PackageDescription": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64679-670-05) ",
"NDC11Code": "64679-0670-05",
"ProductNDC": "64679-670",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202176",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20120914",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules, USP are proton pump inhibitors (PPIs) indicated for the: : 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).",
"Description": "The active ingredient in lansoprazole delayed-release capsule, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole, USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsules for oral administration. The lansoprazole delayed-release capsules, USP are available in two dosage strengths: 15 and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients for 15 and 30 mg: colloidal silicon dioxide, D&C Red 33, FD&C Blue 1, gelatin, hypromellose, iron oxide black, magnesium carbonate, methacrylic acid co-polymer dispersion, polyethylene glycol, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sucrose, sugar sphere, talc, titanium dioxide. In addition 15 mg capsule only: D&C Yellow 10."
},
{
"NDCCode": "64679-670-06",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (64679-670-06) > 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK",
"NDC11Code": "64679-0670-06",
"ProductNDC": "64679-670",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202176",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20120914",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules, USP are proton pump inhibitors (PPIs) indicated for the: : 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).",
"Description": "The active ingredient in lansoprazole delayed-release capsule, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole, USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsules for oral administration. The lansoprazole delayed-release capsules, USP are available in two dosage strengths: 15 and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients for 15 and 30 mg: colloidal silicon dioxide, D&C Red 33, FD&C Blue 1, gelatin, hypromellose, iron oxide black, magnesium carbonate, methacrylic acid co-polymer dispersion, polyethylene glycol, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sucrose, sugar sphere, talc, titanium dioxide. In addition 15 mg capsule only: D&C Yellow 10."
},
{
"NDCCode": "64679-670-07",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64679-670-07) ",
"NDC11Code": "64679-0670-07",
"ProductNDC": "64679-670",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120914",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202176",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20120914",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules, USP are proton pump inhibitors (PPIs) indicated for the: : 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).",
"Description": "The active ingredient in lansoprazole delayed-release capsule, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole, USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsules for oral administration. The lansoprazole delayed-release capsules, USP are available in two dosage strengths: 15 and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients for 15 and 30 mg: colloidal silicon dioxide, D&C Red 33, FD&C Blue 1, gelatin, hypromellose, iron oxide black, magnesium carbonate, methacrylic acid co-polymer dispersion, polyethylene glycol, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sucrose, sugar sphere, talc, titanium dioxide. In addition 15 mg capsule only: D&C Yellow 10."
},
{
"NDCCode": "13537-670-02",
"PackageDescription": "1 TUBE in 1 BOX (13537-670-02) > 30 g in 1 TUBE (13537-670-01)",
"NDC11Code": "13537-0670-02",
"ProductNDC": "13537-670",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Mousse Matiffiant Matte Finish Mousse Foundation Spf 16 Base Textura Mousse Acabado Mate Fps 16",
"ProprietaryNameSuffix": "Claire 1- Beige",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
"DosageFormName": "PASTE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151120",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": ".065; .024; .015",
"StrengthUnit": "g/g; g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "41226-672-02",
"PackageDescription": "1 KIT in 1 PACKAGE (41226-672-02) * 354 mL in 1 BOTTLE (41226-670-01) * 354 mL in 1 BOTTLE (41226-671-01) ",
"NDC11Code": "41226-0672-02",
"ProductNDC": "41226-672",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen Liquid / Acetaminophen Diphenhydramine Hcl Liquid",
"NonProprietaryName": "Acetaminophen, Diphenhydramine Hcl",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20260601",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Kroger",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260601",
"SamplePackage": "N"
},
{
"NDCCode": "50153-110-02",
"PackageDescription": "670 L in 1 CYLINDER (50153-110-02)",
"NDC11Code": "50153-0110-02",
"ProductNDC": "50153-110",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20130326",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Island Equipment Company",
"SubstanceName": "OXYGEN",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "55037-870-02",
"PackageDescription": "670 L in 1 CYLINDER (55037-870-02) ",
"NDC11Code": "55037-0870-02",
"ProductNDC": "55037-870",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen/nitrogen 38/62",
"NonProprietaryName": "Oxygen/nitrogen 38/62",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19870101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205889",
"LabelerName": "MATHESON TRI-GAS, INC.",
"SubstanceName": "OXYGEN",
"StrengthNumber": "380",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19870101",
"SamplePackage": "N"
},
{
"NDCCode": "55648-670-02",
"PackageDescription": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55648-670-02)",
"NDC11Code": "55648-0670-02",
"ProductNDC": "55648-670",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202176",
"LabelerName": "Wockhardt Limited",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Lansoprazole is a proton pump inhibitor (PPI). Refer to DOSAGE and ADMINISTRATION table (below) for indications and usage.",
"Description": "The active ingredient in lansoprazole delayed-release capsule is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white powder which melts with decomposition at about 166°C. Lansoprazole is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsules, USP for oral administration. The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients for 15 mg and 30 mg: colloidal silicon dioxide, D&C Red 33, FD&C Blue 1, gelatin, hypromellose, iron oxide black, magnesium carbonate, methacrylic acid co-polymer dispersion, polyethylene glycol, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sucrose, sugar sphere, talc, titanium dioxide. In addition 15 mg capsule only: D&C Yellow 10."
},
{
"NDCCode": "61786-670-02",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (61786-670-02)",
"NDC11Code": "61786-0670-02",
"ProductNDC": "61786-670",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160504",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203835",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-03-14"
},
{
"NDCCode": "68180-670-02",
"PackageDescription": "500 TABLET in 1 BOTTLE (68180-670-02) ",
"NDC11Code": "68180-0670-02",
"ProductNDC": "68180-670",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lurasidone Hydrochloride",
"NonProprietaryName": "Lurasidone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208031",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "LURASIDONE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230220",
"SamplePackage": "N"
},
{
"NDCCode": "70341-670-02",
"PackageDescription": "1 CONTAINER in 1 CARTON (70341-670-02) > 35 g in 1 CONTAINER (70341-670-01) ",
"NDC11Code": "70341-0670-02",
"ProductNDC": "70341-670",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eco Soul Tone Up Cc 03 Clear Bright",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, Octisalate, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180501",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "The Saem International Co., Ltd.",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE; ZINC OXIDE",
"StrengthNumber": "2.1; 1.4; .7; .66",
"StrengthUnit": "g/35g; g/35g; g/35g; g/35g",
"Status": "Deprecated",
"LastUpdate": "2019-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180501",
"SamplePackage": "N"
},
{
"NDCCode": "70920-670-02",
"PackageDescription": "60 POUCH in 1 CARTON (70920-670-02) > 1.4 g in 1 POUCH (70920-670-01) ",
"NDC11Code": "70920-0670-02",
"ProductNDC": "70920-670",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Roselle Tea Eye Ge L",
"NonProprietaryName": "Niacinamide, Adenosine",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181201",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "JAYJUN COSMETIC Co.,Ltd.",
"SubstanceName": "NIACINAMIDE; ADENOSINE",
"StrengthNumber": ".028; .0005",
"StrengthUnit": "g/1.4g; g/1.4g",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Brightening & Firming."
},
{
"NDCCode": "73991-670-02",
"PackageDescription": "59.147 mL in 1 BOTTLE, SPRAY (73991-670-02) ",
"NDC11Code": "73991-0670-02",
"ProductNDC": "73991-670",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "McConnell Labs Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200424",
"SamplePackage": "N"
},
{
"NDCCode": "75681-670-02",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (75681-670-02) > 60 mL in 1 BOTTLE, SPRAY (75681-670-01) ",
"NDC11Code": "75681-0670-02",
"ProductNDC": "75681-670",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Manime Moisturizing Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200531",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Cospharm Co.,Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "42",
"StrengthUnit": "mL/60mL",
"Status": "Deprecated",
"LastUpdate": "2023-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200531",
"SamplePackage": "N"
},
{
"NDCCode": "80421-100-02",
"PackageDescription": "670 L in 1 CYLINDER (80421-100-02) ",
"NDC11Code": "80421-0100-02",
"ProductNDC": "80421-100",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20200701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205849",
"LabelerName": "Empresas De Soldaduras",
"SubstanceName": "OXYGEN",
"StrengthNumber": "1",
"StrengthUnit": "L/L",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N"
},
{
"NDCCode": "64679-012-01",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (64679-012-01) / 20 mL in 1 VIAL, SINGLE-USE (64679-012-02) ",
"NDC11Code": "64679-0012-01",
"ProductNDC": "64679-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Piperacillin And Tazobactam",
"NonProprietaryName": "Piperacillin Sodium And Tazobactam Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170322",
"EndMarketingDate": "20251130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206996",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "PIPERACILLIN SODIUM; TAZOBACTAM SODIUM",
"StrengthNumber": "4; .5",
"StrengthUnit": "g/20mL; g/20mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170322",
"EndMarketingDatePackage": "20251130",
"SamplePackage": "N"
},
{
"NDCCode": "64679-034-01",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (64679-034-01) / 10 mL in 1 VIAL, SINGLE-USE (64679-034-02) ",
"NDC11Code": "64679-0034-01",
"ProductNDC": "64679-034",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Piperacillin And Tazobactam",
"NonProprietaryName": "Piperacillin Sodium And Tazobactam Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170322",
"EndMarketingDate": "20251130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206996",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "PIPERACILLIN SODIUM; TAZOBACTAM SODIUM",
"StrengthNumber": "2; .25",
"StrengthUnit": "g/10mL; g/10mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170322",
"EndMarketingDatePackage": "20251130",
"SamplePackage": "N"
},
{
"NDCCode": "64679-050-02",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (64679-050-02) > 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "64679-0050-02",
"ProductNDC": "64679-050",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "React",
"NonProprietaryName": "Levonorgestrel",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160413",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202246",
"LabelerName": "Wockhardt USA, LLC",
"SubstanceName": "LEVONORGESTREL",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)."
},
{
"NDCCode": "64679-056-01",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (64679-056-01) / 15 mL in 1 VIAL, SINGLE-USE (64679-056-02) ",
"NDC11Code": "64679-0056-01",
"ProductNDC": "64679-056",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Piperacillin And Tazobactam",
"NonProprietaryName": "Piperacillin Sodium And Tazobactam Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170322",
"EndMarketingDate": "20251130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206996",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "PIPERACILLIN SODIUM; TAZOBACTAM SODIUM",
"StrengthNumber": "3; .375",
"StrengthUnit": "g/15mL; g/15mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170322",
"EndMarketingDatePackage": "20251130",
"SamplePackage": "N"
},
{
"NDCCode": "64679-067-02",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (64679-067-02) > 20 mL in 1 VIAL, SINGLE-USE (64679-067-01) ",
"NDC11Code": "64679-0067-02",
"ProductNDC": "64679-067",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Decitabine",
"NonProprietaryName": "Decitabine",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209056",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "DECITABINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20201214",
"SamplePackage": "N",
"IndicationAndUsage": "Decitabine for injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.",
"Description": "Decitabine is a nucleoside metabolic inhibitor. Decitabine is a fine, white to almost white powder with the molecular formula of C8H12N4O4 and a molecular weight of 228.21. Its chemical name is 4-amino-1-(2-deoxy-β-D-erythro-pentofuranosyl)-1,3,5-triazin-2(1H)-one and it has the following structural formula. Decitabine is soluble in dimethyl sulphoxide, sparingly soluble in water, slightly soluble in methanol and insoluble in Acetonitrile. Decitabine for injection, for intravenous use, is a sterile, white to almost white lyophilized powder supplied in a clear colourless glass single-dose vial. Each 20 mL vial contains 50 mg decitabine,68mg monobasic potassium phosphate (potassium dihydrogen phosphate) and 11.6 mg sodium hydroxide. Sodium hydroxide and/or hydrochloric acid are used for pH adjustment."
},
{
"NDCCode": "64679-101-02",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-101-02) ",
"NDC11Code": "64679-0101-02",
"ProductNDC": "64679-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "(sr)",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201331",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20120515",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (SR) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (1) .",
"Description": "Bupropion hydrochloride extended-release tablets (SR), an antidepressant of the aminoketone class, are chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl) amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, soluble in water, 0.1N HCl and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets (SR) are supplied for oral administration as 100-mg (blue), 150-mg (purple), and 200-mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ammonium Chloride, colloidal silicon dioxide, glyceryl behenate, ydroxyl propyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, stearic acid, talc, titanium dioxide. In addition, the 100-mg tablet contains FD&C Blue No. 1 Lake, the 150-mg tablet contains FD&C Blue No. 2 Lake and FD&C Red No. 40 Lake, and the 200-mg tablet contains FD&C Red No. 40 Lake. Bupropion hydrochloride extended-release tablets, USP (SR), 100 mg, 150 mg and 200 mg, meet USP Dissolution Test 2."
},
{
"NDCCode": "64679-102-02",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-102-02) ",
"NDC11Code": "64679-0102-02",
"ProductNDC": "64679-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "(xl)",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20121121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202189",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20121121",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets, USP (XL) are an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) ( 1.1) , 2 prevention of seasonal affective disorder (SAD) ( 1.2) .",
"Description": "Bupropion hydrochloride, USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNO·HCl. Bupropion hydrochloride powder is white, crystalline, and soluble in water, 0.1N HCl and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg and 300 mg white to off white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: ammonium chloride, colloidal silicon dioxide, ethyl cellulose, eudragit L30D55, glyceryl behenate, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, silicon dioxide, shellac glaze, talc, titanium dioxide, triethyl citrate. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. Meets USP Dissolution Test 16."
},
{
"NDCCode": "64679-103-02",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-103-02) ",
"NDC11Code": "64679-0103-02",
"ProductNDC": "64679-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "(xl)",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202189",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220128",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets, USP (XL) are an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) ( 1.1) , 2 prevention of seasonal affective disorder (SAD) ( 1.2) .",
"Description": "Bupropion hydrochloride, USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNO·HCl. Bupropion hydrochloride powder is white, crystalline, and soluble in water, 0.1N HCl and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg and 300 mg white to off white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: ammonium chloride, colloidal silicon dioxide, ethyl cellulose, eudragit L30D55, glyceryl behenate, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, silicon dioxide, shellac glaze, talc, titanium dioxide, triethyl citrate. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. Meets USP Dissolution Test 16."
},
{
"NDCCode": "64679-105-02",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-105-02) ",
"NDC11Code": "64679-0105-02",
"ProductNDC": "64679-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "(sr)",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201331",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20120515",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (SR) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (1) .",
"Description": "Bupropion hydrochloride extended-release tablets (SR), an antidepressant of the aminoketone class, are chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl) amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, soluble in water, 0.1N HCl and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets (SR) are supplied for oral administration as 100-mg (blue), 150-mg (purple), and 200-mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ammonium Chloride, colloidal silicon dioxide, glyceryl behenate, ydroxyl propyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, stearic acid, talc, titanium dioxide. In addition, the 100-mg tablet contains FD&C Blue No. 1 Lake, the 150-mg tablet contains FD&C Blue No. 2 Lake and FD&C Red No. 40 Lake, and the 200-mg tablet contains FD&C Red No. 40 Lake. Bupropion hydrochloride extended-release tablets, USP (SR), 100 mg, 150 mg and 200 mg, meet USP Dissolution Test 2."
},
{
"NDCCode": "64679-107-02",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-107-02) ",
"NDC11Code": "64679-0107-02",
"ProductNDC": "64679-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "(sr)",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201331",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20120515",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (SR) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (1) .",
"Description": "Bupropion hydrochloride extended-release tablets (SR), an antidepressant of the aminoketone class, are chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl) amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, soluble in water, 0.1N HCl and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets (SR) are supplied for oral administration as 100-mg (blue), 150-mg (purple), and 200-mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ammonium Chloride, colloidal silicon dioxide, glyceryl behenate, ydroxyl propyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, stearic acid, talc, titanium dioxide. In addition, the 100-mg tablet contains FD&C Blue No. 1 Lake, the 150-mg tablet contains FD&C Blue No. 2 Lake and FD&C Red No. 40 Lake, and the 200-mg tablet contains FD&C Red No. 40 Lake. Bupropion hydrochloride extended-release tablets, USP (SR), 100 mg, 150 mg and 200 mg, meet USP Dissolution Test 2."
},
{
"NDCCode": "64679-121-02",
"PackageDescription": "500 TABLET in 1 BOTTLE (64679-121-02) ",
"NDC11Code": "64679-0121-02",
"ProductNDC": "64679-121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090073",
"LabelerName": "Wockhardt USA LLC.",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1).",
"Description": "Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine HCl occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride is available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride, USP. The tablets also contain the following inactive ingredients: silicified microcrystalline cellulose, colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, triacetin, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, triacetin and iron oxide black (10 mg tablets)."
}
]
}
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<Description>The active ingredient in lansoprazole delayed-release capsule, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole, USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsules for oral administration. The lansoprazole delayed-release capsules, USP are available in two dosage strengths: 15 and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients for 15 and 30 mg: colloidal silicon dioxide, D&C Red 33, FD&C Blue 1, gelatin, hypromellose, iron oxide black, magnesium carbonate, methacrylic acid co-polymer dispersion, polyethylene glycol, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sucrose, sugar sphere, talc, titanium dioxide. In addition 15 mg capsule only: D&C Yellow 10.</Description>
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<Description>The active ingredient in lansoprazole delayed-release capsule, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole, USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsules for oral administration. The lansoprazole delayed-release capsules, USP are available in two dosage strengths: 15 and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients for 15 and 30 mg: colloidal silicon dioxide, D&C Red 33, FD&C Blue 1, gelatin, hypromellose, iron oxide black, magnesium carbonate, methacrylic acid co-polymer dispersion, polyethylene glycol, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sucrose, sugar sphere, talc, titanium dioxide. In addition 15 mg capsule only: D&C Yellow 10.</Description>
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<NDCCode>64679-670-03</NDCCode>
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<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<Description>The active ingredient in lansoprazole delayed-release capsule, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole, USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsules for oral administration. The lansoprazole delayed-release capsules, USP are available in two dosage strengths: 15 and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients for 15 and 30 mg: colloidal silicon dioxide, D&C Red 33, FD&C Blue 1, gelatin, hypromellose, iron oxide black, magnesium carbonate, methacrylic acid co-polymer dispersion, polyethylene glycol, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sucrose, sugar sphere, talc, titanium dioxide. In addition 15 mg capsule only: D&C Yellow 10.</Description>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<Description>The active ingredient in lansoprazole delayed-release capsule, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole, USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsules for oral administration. The lansoprazole delayed-release capsules, USP are available in two dosage strengths: 15 and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients for 15 and 30 mg: colloidal silicon dioxide, D&C Red 33, FD&C Blue 1, gelatin, hypromellose, iron oxide black, magnesium carbonate, methacrylic acid co-polymer dispersion, polyethylene glycol, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sucrose, sugar sphere, talc, titanium dioxide. In addition 15 mg capsule only: D&C Yellow 10.</Description>
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<NDCCode>64679-670-05</NDCCode>
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<Status>Deprecated</Status>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Lansoprazole delayed-release capsules, USP are proton pump inhibitors (PPIs) indicated for the: : 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).</IndicationAndUsage>
<Description>The active ingredient in lansoprazole delayed-release capsule, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole, USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsules for oral administration. The lansoprazole delayed-release capsules, USP are available in two dosage strengths: 15 and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients for 15 and 30 mg: colloidal silicon dioxide, D&C Red 33, FD&C Blue 1, gelatin, hypromellose, iron oxide black, magnesium carbonate, methacrylic acid co-polymer dispersion, polyethylene glycol, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sucrose, sugar sphere, talc, titanium dioxide. In addition 15 mg capsule only: D&C Yellow 10.</Description>
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<IndicationAndUsage>Lansoprazole delayed-release capsules, USP are proton pump inhibitors (PPIs) indicated for the: : 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).</IndicationAndUsage>
<Description>The active ingredient in lansoprazole delayed-release capsule, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole, USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsules for oral administration. The lansoprazole delayed-release capsules, USP are available in two dosage strengths: 15 and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients for 15 and 30 mg: colloidal silicon dioxide, D&C Red 33, FD&C Blue 1, gelatin, hypromellose, iron oxide black, magnesium carbonate, methacrylic acid co-polymer dispersion, polyethylene glycol, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sucrose, sugar sphere, talc, titanium dioxide. In addition 15 mg capsule only: D&C Yellow 10.</Description>
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<IndicationAndUsage>Lansoprazole delayed-release capsules, USP are proton pump inhibitors (PPIs) indicated for the: : 1 Treatment of active duodenal ulcer in adults. (1.1), 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2), 3 Maintenance of healed duodenal ulcers in adults. (1.3), 4 Treatment of active benign gastric ulcer in adults. (1.4), 5 Healing of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5), 6 Risk reduction of NSAID-associated gastric ulcer in adults. (1.6), 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7), 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8), 9 Maintenance of healing of EE in adults. (1.9), 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).</IndicationAndUsage>
<Description>The active ingredient in lansoprazole delayed-release capsule, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole, USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsules for oral administration. The lansoprazole delayed-release capsules, USP are available in two dosage strengths: 15 and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients for 15 and 30 mg: colloidal silicon dioxide, D&C Red 33, FD&C Blue 1, gelatin, hypromellose, iron oxide black, magnesium carbonate, methacrylic acid co-polymer dispersion, polyethylene glycol, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sucrose, sugar sphere, talc, titanium dioxide. In addition 15 mg capsule only: D&C Yellow 10.</Description>
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<Description>The active ingredient in lansoprazole delayed-release capsule is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white powder which melts with decomposition at about 166°C. Lansoprazole is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsules, USP for oral administration. The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients for 15 mg and 30 mg: colloidal silicon dioxide, D&C Red 33, FD&C Blue 1, gelatin, hypromellose, iron oxide black, magnesium carbonate, methacrylic acid co-polymer dispersion, polyethylene glycol, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sucrose, sugar sphere, talc, titanium dioxide. In addition 15 mg capsule only: D&C Yellow 10.</Description>
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<LastUpdate>2017-03-14</LastUpdate>
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<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20200701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205849</ApplicationNumber>
<LabelerName>Empresas De Soldaduras</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>L/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64679-012-01</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (64679-012-01) / 20 mL in 1 VIAL, SINGLE-USE (64679-012-02) </PackageDescription>
<NDC11Code>64679-0012-01</NDC11Code>
<ProductNDC>64679-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Piperacillin And Tazobactam</ProprietaryName>
<NonProprietaryName>Piperacillin Sodium And Tazobactam Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170322</StartMarketingDate>
<EndMarketingDate>20251130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206996</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>PIPERACILLIN SODIUM; TAZOBACTAM SODIUM</SubstanceName>
<StrengthNumber>4; .5</StrengthNumber>
<StrengthUnit>g/20mL; g/20mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170322</StartMarketingDatePackage>
<EndMarketingDatePackage>20251130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64679-034-01</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (64679-034-01) / 10 mL in 1 VIAL, SINGLE-USE (64679-034-02) </PackageDescription>
<NDC11Code>64679-0034-01</NDC11Code>
<ProductNDC>64679-034</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Piperacillin And Tazobactam</ProprietaryName>
<NonProprietaryName>Piperacillin Sodium And Tazobactam Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170322</StartMarketingDate>
<EndMarketingDate>20251130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206996</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>PIPERACILLIN SODIUM; TAZOBACTAM SODIUM</SubstanceName>
<StrengthNumber>2; .25</StrengthNumber>
<StrengthUnit>g/10mL; g/10mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170322</StartMarketingDatePackage>
<EndMarketingDatePackage>20251130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64679-050-02</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (64679-050-02) > 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64679-0050-02</NDC11Code>
<ProductNDC>64679-050</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>React</ProprietaryName>
<NonProprietaryName>Levonorgestrel</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160413</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202246</ApplicationNumber>
<LabelerName>Wockhardt USA, LLC</LabelerName>
<SubstanceName>LEVONORGESTREL</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64679-056-01</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (64679-056-01) / 15 mL in 1 VIAL, SINGLE-USE (64679-056-02) </PackageDescription>
<NDC11Code>64679-0056-01</NDC11Code>
<ProductNDC>64679-056</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Piperacillin And Tazobactam</ProprietaryName>
<NonProprietaryName>Piperacillin Sodium And Tazobactam Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170322</StartMarketingDate>
<EndMarketingDate>20251130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206996</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>PIPERACILLIN SODIUM; TAZOBACTAM SODIUM</SubstanceName>
<StrengthNumber>3; .375</StrengthNumber>
<StrengthUnit>g/15mL; g/15mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170322</StartMarketingDatePackage>
<EndMarketingDatePackage>20251130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64679-067-02</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (64679-067-02) > 20 mL in 1 VIAL, SINGLE-USE (64679-067-01) </PackageDescription>
<NDC11Code>64679-0067-02</NDC11Code>
<ProductNDC>64679-067</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Decitabine</ProprietaryName>
<NonProprietaryName>Decitabine</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20201214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209056</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>DECITABINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Decitabine for injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.</IndicationAndUsage>
<Description>Decitabine is a nucleoside metabolic inhibitor. Decitabine is a fine, white to almost white powder with the molecular formula of C8H12N4O4 and a molecular weight of 228.21. Its chemical name is 4-amino-1-(2-deoxy-β-D-erythro-pentofuranosyl)-1,3,5-triazin-2(1H)-one and it has the following structural formula. Decitabine is soluble in dimethyl sulphoxide, sparingly soluble in water, slightly soluble in methanol and insoluble in Acetonitrile. Decitabine for injection, for intravenous use, is a sterile, white to almost white lyophilized powder supplied in a clear colourless glass single-dose vial. Each 20 mL vial contains 50 mg decitabine,68mg monobasic potassium phosphate (potassium dihydrogen phosphate) and 11.6 mg sodium hydroxide. Sodium hydroxide and/or hydrochloric acid are used for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>64679-101-02</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-101-02) </PackageDescription>
<NDC11Code>64679-0101-02</NDC11Code>
<ProductNDC>64679-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>(sr)</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201331</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (SR) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (1) .</IndicationAndUsage>
<Description>Bupropion hydrochloride extended-release tablets (SR), an antidepressant of the aminoketone class, are chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl) amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, soluble in water, 0.1N HCl and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets (SR) are supplied for oral administration as 100-mg (blue), 150-mg (purple), and 200-mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ammonium Chloride, colloidal silicon dioxide, glyceryl behenate, ydroxyl propyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, stearic acid, talc, titanium dioxide. In addition, the 100-mg tablet contains FD&C Blue No. 1 Lake, the 150-mg tablet contains FD&C Blue No. 2 Lake and FD&C Red No. 40 Lake, and the 200-mg tablet contains FD&C Red No. 40 Lake. Bupropion hydrochloride extended-release tablets, USP (SR), 100 mg, 150 mg and 200 mg, meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>64679-102-02</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-102-02) </PackageDescription>
<NDC11Code>64679-0102-02</NDC11Code>
<ProductNDC>64679-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>(xl)</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202189</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets, USP (XL) are an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) ( 1.1) , 2 prevention of seasonal affective disorder (SAD) ( 1.2) .</IndicationAndUsage>
<Description>Bupropion hydrochloride, USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNO·HCl. Bupropion hydrochloride powder is white, crystalline, and soluble in water, 0.1N HCl and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg and 300 mg white to off white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: ammonium chloride, colloidal silicon dioxide, ethyl cellulose, eudragit L30D55, glyceryl behenate, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, silicon dioxide, shellac glaze, talc, titanium dioxide, triethyl citrate. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. Meets USP Dissolution Test 16.</Description>
</NDC>
<NDC>
<NDCCode>64679-103-02</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-103-02) </PackageDescription>
<NDC11Code>64679-0103-02</NDC11Code>
<ProductNDC>64679-103</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>(xl)</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220128</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202189</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets, USP (XL) are an aminoketone antidepressant, indicated for: 1 treatment of major depressive disorder (MDD) ( 1.1) , 2 prevention of seasonal affective disorder (SAD) ( 1.2) .</IndicationAndUsage>
<Description>Bupropion hydrochloride, USP, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C 13H 18ClNO·HCl. Bupropion hydrochloride powder is white, crystalline, and soluble in water, 0.1N HCl and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:. Bupropion hydrochloride extended-release tablets, USP (XL) are supplied for oral administration as 150 mg and 300 mg white to off white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: ammonium chloride, colloidal silicon dioxide, ethyl cellulose, eudragit L30D55, glyceryl behenate, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, silicon dioxide, shellac glaze, talc, titanium dioxide, triethyl citrate. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. Meets USP Dissolution Test 16.</Description>
</NDC>
<NDC>
<NDCCode>64679-105-02</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-105-02) </PackageDescription>
<NDC11Code>64679-0105-02</NDC11Code>
<ProductNDC>64679-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>(sr)</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201331</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (SR) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (1) .</IndicationAndUsage>
<Description>Bupropion hydrochloride extended-release tablets (SR), an antidepressant of the aminoketone class, are chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl) amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, soluble in water, 0.1N HCl and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets (SR) are supplied for oral administration as 100-mg (blue), 150-mg (purple), and 200-mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ammonium Chloride, colloidal silicon dioxide, glyceryl behenate, ydroxyl propyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, stearic acid, talc, titanium dioxide. In addition, the 100-mg tablet contains FD&C Blue No. 1 Lake, the 150-mg tablet contains FD&C Blue No. 2 Lake and FD&C Red No. 40 Lake, and the 200-mg tablet contains FD&C Red No. 40 Lake. Bupropion hydrochloride extended-release tablets, USP (SR), 100 mg, 150 mg and 200 mg, meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>64679-107-02</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-107-02) </PackageDescription>
<NDC11Code>64679-0107-02</NDC11Code>
<ProductNDC>64679-107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>(sr)</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120515</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201331</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (SR) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (1) .</IndicationAndUsage>
<Description>Bupropion hydrochloride extended-release tablets (SR), an antidepressant of the aminoketone class, are chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl) amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, soluble in water, 0.1N HCl and in alcohol. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets (SR) are supplied for oral administration as 100-mg (blue), 150-mg (purple), and 200-mg (pink), film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Ammonium Chloride, colloidal silicon dioxide, glyceryl behenate, ydroxyl propyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, stearic acid, talc, titanium dioxide. In addition, the 100-mg tablet contains FD&C Blue No. 1 Lake, the 150-mg tablet contains FD&C Blue No. 2 Lake and FD&C Red No. 40 Lake, and the 200-mg tablet contains FD&C Red No. 40 Lake. Bupropion hydrochloride extended-release tablets, USP (SR), 100 mg, 150 mg and 200 mg, meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>64679-121-02</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (64679-121-02) </PackageDescription>
<NDC11Code>64679-0121-02</NDC11Code>
<ProductNDC>64679-121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090073</ApplicationNumber>
<LabelerName>Wockhardt USA LLC.</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1).</IndicationAndUsage>
<Description>Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine HCl occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride is available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride, USP. The tablets also contain the following inactive ingredients: silicified microcrystalline cellulose, colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, triacetin, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, triacetin and iron oxide black (10 mg tablets).</Description>
</NDC>
</NDCList>