{
"NDC": [
{
"NDCCode": "55111-399-05",
"PackageDescription": "500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-399-05) ",
"NDC11Code": "55111-0399-05",
"ProductNDC": "55111-399",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091269",
"LabelerName": "Dr.Reddy's Laboratories Ltd.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101015",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsule is a proton pump inhibitor (PPIs) indicated for the:. Treatment of active duodenal ulcer in adults. (1.1). Eradication of H. pylori to reduce the risk of duodenal ulcer. recurrence in adults. (1.2). Maintenance of healed duodenal ulcers in adults. (1.3). Treatment of active benign gastric ulcer in adults. (1.4). Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5). Risk reduction of NSAID-associated gastric ulcer in adults. (1.6). Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older.(1.7). Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8). Maintenance of healing of EE in adults. (1.9). Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).",
"Description": "The active ingredient in lansoprazole delayed-release capsules USP is lansoprazole USP, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole USP has the following structure:. Lansoprazole USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole USP is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole USP 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 USP is supplied as delayed-release capsules for oral adminsitration. The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole USP per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: ammonium hydroxide, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, propylene glycol, shellac, simethicone, starch, sucrose, sugar spheres, talc, and titanium dioxide. Components of the gelatin capsule include gelatin, iron oxide red, iron oxide yellow, FD&C Blue 2, sodium lauryl sulphate and titanium dioxide for 15 mg capsules and gelatin, iron oxide black, iron oxide red, iron oxide yellow, sodium lauryl sulphate and titanium dioxide for 30 mg capsules."
},
{
"NDCCode": "55111-399-01",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-399-01) ",
"NDC11Code": "55111-0399-01",
"ProductNDC": "55111-399",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091269",
"LabelerName": "Dr.Reddy's Laboratories Ltd.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101015",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsule is a proton pump inhibitor (PPIs) indicated for the:. Treatment of active duodenal ulcer in adults. (1.1). Eradication of H. pylori to reduce the risk of duodenal ulcer. recurrence in adults. (1.2). Maintenance of healed duodenal ulcers in adults. (1.3). Treatment of active benign gastric ulcer in adults. (1.4). Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5). Risk reduction of NSAID-associated gastric ulcer in adults. (1.6). Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older.(1.7). Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8). Maintenance of healing of EE in adults. (1.9). Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).",
"Description": "The active ingredient in lansoprazole delayed-release capsules USP is lansoprazole USP, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole USP has the following structure:. Lansoprazole USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole USP is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole USP 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 USP is supplied as delayed-release capsules for oral adminsitration. The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole USP per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: ammonium hydroxide, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, propylene glycol, shellac, simethicone, starch, sucrose, sugar spheres, talc, and titanium dioxide. Components of the gelatin capsule include gelatin, iron oxide red, iron oxide yellow, FD&C Blue 2, sodium lauryl sulphate and titanium dioxide for 15 mg capsules and gelatin, iron oxide black, iron oxide red, iron oxide yellow, sodium lauryl sulphate and titanium dioxide for 30 mg capsules."
},
{
"NDCCode": "55111-399-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-399-30) ",
"NDC11Code": "55111-0399-30",
"ProductNDC": "55111-399",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091269",
"LabelerName": "Dr.Reddy's Laboratories Ltd.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101015",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsule is a proton pump inhibitor (PPIs) indicated for the:. Treatment of active duodenal ulcer in adults. (1.1). Eradication of H. pylori to reduce the risk of duodenal ulcer. recurrence in adults. (1.2). Maintenance of healed duodenal ulcers in adults. (1.3). Treatment of active benign gastric ulcer in adults. (1.4). Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5). Risk reduction of NSAID-associated gastric ulcer in adults. (1.6). Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older.(1.7). Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8). Maintenance of healing of EE in adults. (1.9). Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).",
"Description": "The active ingredient in lansoprazole delayed-release capsules USP is lansoprazole USP, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole USP has the following structure:. Lansoprazole USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole USP is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole USP 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 USP is supplied as delayed-release capsules for oral adminsitration. The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole USP per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: ammonium hydroxide, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, propylene glycol, shellac, simethicone, starch, sucrose, sugar spheres, talc, and titanium dioxide. Components of the gelatin capsule include gelatin, iron oxide red, iron oxide yellow, FD&C Blue 2, sodium lauryl sulphate and titanium dioxide for 15 mg capsules and gelatin, iron oxide black, iron oxide red, iron oxide yellow, sodium lauryl sulphate and titanium dioxide for 30 mg capsules."
},
{
"NDCCode": "55111-399-60",
"PackageDescription": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-399-60) ",
"NDC11Code": "55111-0399-60",
"ProductNDC": "55111-399",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091269",
"LabelerName": "Dr.Reddy's Laboratories Ltd.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101015",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsule is a proton pump inhibitor (PPIs) indicated for the:. Treatment of active duodenal ulcer in adults. (1.1). Eradication of H. pylori to reduce the risk of duodenal ulcer. recurrence in adults. (1.2). Maintenance of healed duodenal ulcers in adults. (1.3). Treatment of active benign gastric ulcer in adults. (1.4). Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5). Risk reduction of NSAID-associated gastric ulcer in adults. (1.6). Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older.(1.7). Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8). Maintenance of healing of EE in adults. (1.9). Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).",
"Description": "The active ingredient in lansoprazole delayed-release capsules USP is lansoprazole USP, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole USP has the following structure:. Lansoprazole USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole USP is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole USP 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 USP is supplied as delayed-release capsules for oral adminsitration. The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole USP per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: ammonium hydroxide, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, propylene glycol, shellac, simethicone, starch, sucrose, sugar spheres, talc, and titanium dioxide. Components of the gelatin capsule include gelatin, iron oxide red, iron oxide yellow, FD&C Blue 2, sodium lauryl sulphate and titanium dioxide for 15 mg capsules and gelatin, iron oxide black, iron oxide red, iron oxide yellow, sodium lauryl sulphate and titanium dioxide for 30 mg capsules."
},
{
"NDCCode": "55111-399-79",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (55111-399-79) > 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK",
"NDC11Code": "55111-0399-79",
"ProductNDC": "55111-399",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091269",
"LabelerName": "Dr.Reddy's Laboratories Ltd.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101015",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsule is a proton pump inhibitor (PPIs) indicated for the:. Treatment of active duodenal ulcer in adults. (1.1). Eradication of H. pylori to reduce the risk of duodenal ulcer. recurrence in adults. (1.2). Maintenance of healed duodenal ulcers in adults. (1.3). Treatment of active benign gastric ulcer in adults. (1.4). Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5). Risk reduction of NSAID-associated gastric ulcer in adults. (1.6). Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older.(1.7). Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8). Maintenance of healing of EE in adults. (1.9). Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).",
"Description": "The active ingredient in lansoprazole delayed-release capsules USP is lansoprazole USP, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole USP has the following structure:. Lansoprazole USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole USP is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole USP 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 USP is supplied as delayed-release capsules for oral adminsitration. The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole USP per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: ammonium hydroxide, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, propylene glycol, shellac, simethicone, starch, sucrose, sugar spheres, talc, and titanium dioxide. Components of the gelatin capsule include gelatin, iron oxide red, iron oxide yellow, FD&C Blue 2, sodium lauryl sulphate and titanium dioxide for 15 mg capsules and gelatin, iron oxide black, iron oxide red, iron oxide yellow, sodium lauryl sulphate and titanium dioxide for 30 mg capsules."
},
{
"NDCCode": "55111-399-90",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-399-90) ",
"NDC11Code": "55111-0399-90",
"ProductNDC": "55111-399",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091269",
"LabelerName": "Dr.Reddy's Laboratories Ltd.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2022-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101015",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsule is a proton pump inhibitor (PPIs) indicated for the:. Treatment of active duodenal ulcer in adults. (1.1). Eradication of H. pylori to reduce the risk of duodenal ulcer. recurrence in adults. (1.2). Maintenance of healed duodenal ulcers in adults. (1.3). Treatment of active benign gastric ulcer in adults. (1.4). Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5). Risk reduction of NSAID-associated gastric ulcer in adults. (1.6). Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older.(1.7). Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8). Maintenance of healing of EE in adults. (1.9). Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).",
"Description": "The active ingredient in lansoprazole delayed-release capsules USP is lansoprazole USP, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole USP has the following structure:. Lansoprazole USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole USP is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole USP 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 USP is supplied as delayed-release capsules for oral adminsitration. The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole USP per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: ammonium hydroxide, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, propylene glycol, shellac, simethicone, starch, sucrose, sugar spheres, talc, and titanium dioxide. Components of the gelatin capsule include gelatin, iron oxide red, iron oxide yellow, FD&C Blue 2, sodium lauryl sulphate and titanium dioxide for 15 mg capsules and gelatin, iron oxide black, iron oxide red, iron oxide yellow, sodium lauryl sulphate and titanium dioxide for 30 mg capsules."
},
{
"NDCCode": "55111-399-92",
"PackageDescription": "2500 CAPSULE, DELAYED RELEASE in 1 POUCH (55111-399-92)",
"NDC11Code": "55111-0399-92",
"ProductNDC": "55111-399",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"StartMarketingDate": "20130620",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2020-02-20",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "29300-399-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (29300-399-05) ",
"NDC11Code": "29300-0399-05",
"ProductNDC": "29300-399",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213359",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210811",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride extended-release tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white crystals or white crystalline powder with a molecular formula of C4H11N5 HCl and a molecular weight of 165.62. It is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone, and in methylene chloride. The pKa of metformin hydrochloride is 2.8 and 11.5. The pH of a 5% aqueous solution of metformin hydrochloride is between 6 and 7. Metformin hydrochloride extended-release tablets, USP contain 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin hydrochloride extended-release tablets, USP 500 mg and 750 mg contain the inactive ingredients carboxymethylcellulose sodium, hypromellose and magnesium stearate. Meets USP Dissolution Test 22."
},
{
"NDCCode": "42961-399-05",
"PackageDescription": "250 PACKET in 1 BOX (42961-399-05) / 2 TABLET in 1 PACKET (42961-399-01) ",
"NDC11Code": "42961-0399-05",
"ProductNDC": "42961-399",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Xpect Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210330",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Cintas Corporation",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210330",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: headache, the common cold, backache, minor pain of arthritis, toothache, muscular aches, premenstrual and menstrual cramps. temporarily reduces fever ."
},
{
"NDCCode": "43602-399-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-399-05) ",
"NDC11Code": "43602-0399-05",
"ProductNDC": "43602-399",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Citrate",
"NonProprietaryName": "Potassium Citrate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214420",
"LabelerName": "Ascent Pharmaceuticals Inc",
"SubstanceName": "POTASSIUM CITRATE",
"StrengthNumber": "5",
"StrengthUnit": "meq/1",
"Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210215",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium Citrate extended-release tablets are a citrate salt of potassium indicated for the management of: 1 Renal tubular acidosis (RTA) with calcium stones (1.1), 2 Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2), 3 Uric acid lithiasis with or without calcium stones (1.3).",
"Description": "Potassium Citrate extended release tablets are a citrate salt of potassium. Its empirical formula is K3C6H5O7 H2O, and it has the following chemical structure. Potassium Citrate extended release tablets are off white to tan yellowish, oral wax-matrix tablets, contain 5 mEq (540 mg) potassium citrate, 10 mEq (1080 mg) potassium citrate and 15 mEq (1620 mg) potassium citrate each. Inactive ingredients include carnauba wax, silicon dioxide and magnesium stearate. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "49643-399-05",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (49643-399-05) ",
"NDC11Code": "49643-0399-05",
"ProductNDC": "49643-399",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Black Cottonwood Pollen",
"NonProprietaryName": "Populus Trichocarpa",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "POPULUS TRICHOCARPA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "63730-399-05",
"PackageDescription": "100 mL in 1 CARTON (63730-399-05)",
"NDC11Code": "63730-0399-05",
"ProductNDC": "63730-399",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "The Cure Sheer Cream",
"NonProprietaryName": "Octinoxate, Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170308",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Natura Bisse International",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "2; 4",
"StrengthUnit": "mg/50mL; g/50mL",
"Status": "Deprecated",
"LastUpdate": "2019-06-18",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "68428-399-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-399-05) ",
"NDC11Code": "68428-0399-05",
"ProductNDC": "68428-399",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Galphimia Glauca",
"NonProprietaryName": "Galphimia Glauca Flowering Top",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100215",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "GALPHIMIA GLAUCA FLOWERING TOP",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20100215",
"SamplePackage": "N",
"IndicationAndUsage": "Indications. GALPHIMIA Sneezing."
},
{
"NDCCode": "69837-399-05",
"PackageDescription": "1 TUBE in 1 CARTON (69837-399-05) > 150 mL in 1 TUBE",
"NDC11Code": "69837-0399-05",
"ProductNDC": "69837-399",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202027",
"LabelerName": "International Brand Management, LLC",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "16.05",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Active ingredient: diclofenac sodium 16.05 mg. Excipients: alcohol (11.3%), dimethyl sulfoxide. glycerin, propylene glycol, purified water."
},
{
"NDCCode": "69837-500-05",
"PackageDescription": "1 KIT in 1 KIT (69837-500-05) * 1 TUBE in 1 KIT (69837-399-05) > 150 mL in 1 TUBE * 1 CARTON in 1 KIT > 118 g in 1 CARTON (69837-210-10)",
"NDC11Code": "69837-0500-05",
"ProductNDC": "69837-500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sure Result Dss Premium Pak",
"NonProprietaryName": "Diclofenac Sodium, Capsaicin",
"DosageFormName": "KIT",
"StartMarketingDate": "20160210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202027",
"LabelerName": "International Brand Management, LLC",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "84525-399-05",
"PackageDescription": "100 mL in 1 BOTTLE (84525-399-05) ",
"NDC11Code": "84525-0399-05",
"ProductNDC": "84525-399",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "The Organic Avocado Anti Wrinkle Essence",
"NonProprietaryName": "The Organic Avocado Anti Wrinkle Essence",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250111",
"EndMarketingDate": "20310111",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Ziqiu Import Export Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20250111",
"EndMarketingDatePackage": "20310111",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "84549-399-05",
"PackageDescription": "10 mL in 1 SYRINGE (84549-399-05) ",
"NDC11Code": "84549-0399-05",
"ProductNDC": "84549-399",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Procainamide Hydrochloride",
"NonProprietaryName": "Procainamide Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20161221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088636",
"LabelerName": "ProPharma Distribution",
"SubstanceName": "PROCAINAMIDE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250901",
"SamplePackage": "N",
"IndicationAndUsage": "Procainamide hydrochloride injection is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life-threatening. Because of the proarrhythmic effects of procainamide, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of procainamide treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias. Because procainamide has the potential to produce serious hematological disorders (0.5 percent) particularly leukopenia or agranulocytosis (sometimes fatal), its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment clearly outweigh the risks. (see WARNINGSand Boxed Warning.).",
"Description": "Procainamide Hydrochloride Injection, USP, is a sterile, nonpyrogenic solution of procainamide hydrochloride in Water for Injection. It is available in 100 mg per mL concentration. The 100 mg per mL potency contains 0.9% w/v benzyl alcohol and 0.09% sodium bisulfite as preservatives. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH 5.0 (4.0 to 6.0). Headspace nitrogen gassed. Procainamide hydrochloride, a Group 1A cardiac antiarrhythmic drug, is ρ-amino-N-[2-(diethylamino) ethyl] benzamide mono-hydrochloride. It has the following structural formula. M.W. 271.79. *(locus for acetylation to N-acetyl procainamide). It differs from procaine which is the p-aminobenzoyl ester of 2-(diethylamino)-ethanol. Procainamide as the free base has a pK aof 9.23; the monohydrochloride is very soluble in water."
},
{
"NDCCode": "84756-399-05",
"PackageDescription": "100 g in 1 BOX (84756-399-05) ",
"NDC11Code": "84756-0399-05",
"ProductNDC": "84756-399",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Moisturizing Smoothes Wrinkles",
"NonProprietaryName": "Trstay Moisturizing Smoothes Wrinkles",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241122",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Yiwu Luoxin E �Commerce Co Ltd",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241122",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "84827-399-05",
"PackageDescription": "100 mL in 1 BOX (84827-399-05) ",
"NDC11Code": "84827-0399-05",
"ProductNDC": "84827-399",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Beard Oil Softening With Argan Oil",
"NonProprietaryName": "Beard Oil Softening With Argan Oil",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241104",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Yiwu Ziqiu Import Export Co Ltd",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241104",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "55111-112-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (55111-112-05) ",
"NDC11Code": "55111-0112-05",
"ProductNDC": "55111-112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Moxifloxacin",
"NonProprietaryName": "Moxifloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140305",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076938",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "MOXIFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Active",
"LastUpdate": "2021-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140305",
"SamplePackage": "N",
"Description": "Moxifloxacin hydrochloride USP is a synthetic antibacterial agent for oral administration. Moxifloxacin, a fluoroquinolone, is available as the monohydrochloride salt of 1-cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. It is a slightly yellow to yellow powder or crystals with a molecular weight of 437.9. Its molecular formula is C21H24FN3O4*HCl and its chemical structure is as follows."
},
{
"NDCCode": "55111-121-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (55111-121-05) ",
"NDC11Code": "55111-0121-05",
"ProductNDC": "55111-121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120717",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091650",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120717",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.",
"Description": "Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). The molecular formula of atorvastatin calcium is C66H68CaF2N4O10and its molecular weight is 1155.36. Its structural formula is:. Atorvastatin calcium is a white to off-white colored powder free from visible extraneous matter. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral administration contain 10, 20 and 40 mg atorvastatin and the following inactive ingredients: Basic butylated methacrylate copolymer, crospovidone, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate, methanol, microcrystalline cellulose, sodium bicarbonate and sodium lauryl sulphate. The tablet coating contains isopropyl alcohol, methylene chloride and coloring agent opadry OY-58900 white contains polyethylene glycol, titanium dioxide and hypromellose."
},
{
"NDCCode": "55111-122-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (55111-122-05) ",
"NDC11Code": "55111-0122-05",
"ProductNDC": "55111-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120717",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091650",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120717",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.",
"Description": "Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). The molecular formula of atorvastatin calcium is C66H68CaF2N4O10and its molecular weight is 1155.36. Its structural formula is:. Atorvastatin calcium is a white to off-white colored powder free from visible extraneous matter. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral administration contain 10, 20 and 40 mg atorvastatin and the following inactive ingredients: Basic butylated methacrylate copolymer, crospovidone, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate, methanol, microcrystalline cellulose, sodium bicarbonate and sodium lauryl sulphate. The tablet coating contains isopropyl alcohol, methylene chloride and coloring agent opadry OY-58900 white contains polyethylene glycol, titanium dioxide and hypromellose."
},
{
"NDCCode": "55111-123-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (55111-123-05) ",
"NDC11Code": "55111-0123-05",
"ProductNDC": "55111-123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120717",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091650",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120717",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.",
"Description": "Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). The molecular formula of atorvastatin calcium is C66H68CaF2N4O10and its molecular weight is 1155.36. Its structural formula is:. Atorvastatin calcium is a white to off-white colored powder free from visible extraneous matter. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral administration contain 10, 20 and 40 mg atorvastatin and the following inactive ingredients: Basic butylated methacrylate copolymer, crospovidone, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate, methanol, microcrystalline cellulose, sodium bicarbonate and sodium lauryl sulphate. The tablet coating contains isopropyl alcohol, methylene chloride and coloring agent opadry OY-58900 white contains polyethylene glycol, titanium dioxide and hypromellose."
},
{
"NDCCode": "55111-124-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (55111-124-05) ",
"NDC11Code": "55111-0124-05",
"ProductNDC": "55111-124",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120717",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202357",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120717",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.",
"Description": "Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). The molecular formula of atorvastatin calcium is C66H68CaF2N4O10and its molecular weight is 1155.36. Its structural formula is:. Atorvastatin calcium is a white to off-white colored powder free from visible extraneous matter. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral administration contain 80 mg atorvastatin and the following inactive ingredients: Basic butylated methacrylate copolymer, crospovidone, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate, methanol, microcrystalline cellulose, sodium bicarbonate and sodium lauryl sulphate. The tablet coating contains lecithin, polyvinyl alcohol, talc, titanium dioxide, and xanthan gum. Atorvastatin calcium tablets meets USP Dissolution Test 2."
},
{
"NDCCode": "55111-126-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (55111-126-05) ",
"NDC11Code": "55111-0126-05",
"ProductNDC": "55111-126",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20040609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075593",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20040609",
"SamplePackage": "N",
"Description": "Ciprofloxacin tablets USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydratesalt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid.It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 100 mg, 250 mg, 500 mg and 750 strengths. Each ciprofloxacin film-coated tablet contains 100 mg (equivalent to 116.4 mg ciprofloxacin hydrochloride monohydrate) or 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets are white. The inactive ingredients are colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "55111-127-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (55111-127-05) ",
"NDC11Code": "55111-0127-05",
"ProductNDC": "55111-127",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20040609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075593",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20040609",
"SamplePackage": "N",
"Description": "Ciprofloxacin tablets USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydratesalt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid.It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 100 mg, 250 mg, 500 mg and 750 strengths. Each ciprofloxacin film-coated tablet contains 100 mg (equivalent to 116.4 mg ciprofloxacin hydrochloride monohydrate) or 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets are white. The inactive ingredients are colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "55111-128-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (55111-128-05) ",
"NDC11Code": "55111-0128-05",
"ProductNDC": "55111-128",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20040609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075593",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20040609",
"SamplePackage": "N",
"Description": "Ciprofloxacin tablets USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydratesalt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid.It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 100 mg, 250 mg, 500 mg and 750 strengths. Each ciprofloxacin film-coated tablet contains 100 mg (equivalent to 116.4 mg ciprofloxacin hydrochloride monohydrate) or 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets are white. The inactive ingredients are colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "55111-129-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (55111-129-05) ",
"NDC11Code": "55111-0129-05",
"ProductNDC": "55111-129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ranitidine Hydrochloride",
"NonProprietaryName": "Ranitidine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20010112",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075742",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2018-11-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20010112",
"SamplePackage": "N",
"IndicationAndUsage": "Ranitidine is indicated in:. 1. Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. 2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year. 3.The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis). 4. Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks. 5.Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year. 6.Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg two times a day. 7. Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg 4 times daily. 8. Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks. Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.",
"Description": "Ranitidine hydrochloride (HCl) USP, is a histamine H2-receptor antagonist. Chemically it is N-[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N’-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structural formula. The molecular formula is C13H22N4O3SHCl, representing a molecular weight of 350.87. Ranitidine hydrochloride USP is a white to pale yellow, crystalline practically odorless powder, is sensitive to light and moisture. It is very soluble in water and sparingly soluble in alcohol. Each Ranitidine Hydrochloride capsule, for oral administration, contains 167.4 mg or 334.8 mg of ranitidine hydrochloride equivalent to 150 mg or 300 mg of ranitidine, respectively. In addition, each capsule contains the following inactive ingredients: Microcrystalline Cellulose, Sodium Starch Glycolate, Magnesium Stearate. The capsule shells contain Black Iron Oxide, Red Iron Oxide T3469, Yellow Iron Oxide T3506, Titanium Dioxide and Gelatin. The capsule shells are imprinted with edible ink."
},
{
"NDCCode": "55111-143-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (55111-143-05) ",
"NDC11Code": "55111-0143-05",
"ProductNDC": "55111-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076658",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
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"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140620",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of:. 1. Vaginal candidiasis (vaginal yeast infections due to Candida). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.",
"Description": "Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder, which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropyl alcohol and in chloroform. Slightly soluble in water, very slightly soluble in toluene. Fluconazole tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: dibasic calcium phosphate anhydrous, ferric oxide (iron oxide, red), magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and starch. Fluconazole tablets meets USP Dissolution Test 2."
},
{
"NDCCode": "55111-144-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (55111-144-05) ",
"NDC11Code": "55111-0144-05",
"ProductNDC": "55111-144",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076658",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140620",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of:. 1. Vaginal candidiasis (vaginal yeast infections due to Candida). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.",
"Description": "Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder, which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropyl alcohol and in chloroform. Slightly soluble in water, very slightly soluble in toluene. Fluconazole tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: dibasic calcium phosphate anhydrous, ferric oxide (iron oxide, red), magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and starch. Fluconazole tablets meets USP Dissolution Test 2."
}
]
}
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<NDCList>
<NDC>
<NDCCode>55111-399-05</NDCCode>
<PackageDescription>500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-399-05) </PackageDescription>
<NDC11Code>55111-0399-05</NDC11Code>
<ProductNDC>55111-399</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
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<LabelerName>Dr.Reddy's Laboratories Ltd.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lansoprazole delayed-release capsule is a proton pump inhibitor (PPIs) indicated for the:. Treatment of active duodenal ulcer in adults. (1.1). Eradication of H. pylori to reduce the risk of duodenal ulcer. recurrence in adults. (1.2). Maintenance of healed duodenal ulcers in adults. (1.3). Treatment of active benign gastric ulcer in adults. (1.4). Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5). Risk reduction of NSAID-associated gastric ulcer in adults. (1.6). Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older.(1.7). Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8). Maintenance of healing of EE in adults. (1.9). Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).</IndicationAndUsage>
<Description>The active ingredient in lansoprazole delayed-release capsules USP is lansoprazole USP, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole USP has the following structure:. Lansoprazole USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole USP is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole USP 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 USP is supplied as delayed-release capsules for oral adminsitration. The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole USP per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: ammonium hydroxide, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, propylene glycol, shellac, simethicone, starch, sucrose, sugar spheres, talc, and titanium dioxide. Components of the gelatin capsule include gelatin, iron oxide red, iron oxide yellow, FD&C Blue 2, sodium lauryl sulphate and titanium dioxide for 15 mg capsules and gelatin, iron oxide black, iron oxide red, iron oxide yellow, sodium lauryl sulphate and titanium dioxide for 30 mg capsules.</Description>
</NDC>
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<NDCCode>55111-399-01</NDCCode>
<PackageDescription>100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-399-01) </PackageDescription>
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<ApplicationNumber>ANDA091269</ApplicationNumber>
<LabelerName>Dr.Reddy's Laboratories Ltd.</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
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<Status>Active</Status>
<LastUpdate>2022-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lansoprazole delayed-release capsule is a proton pump inhibitor (PPIs) indicated for the:. Treatment of active duodenal ulcer in adults. (1.1). Eradication of H. pylori to reduce the risk of duodenal ulcer. recurrence in adults. (1.2). Maintenance of healed duodenal ulcers in adults. (1.3). Treatment of active benign gastric ulcer in adults. (1.4). Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5). Risk reduction of NSAID-associated gastric ulcer in adults. (1.6). Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older.(1.7). Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8). Maintenance of healing of EE in adults. (1.9). Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).</IndicationAndUsage>
<Description>The active ingredient in lansoprazole delayed-release capsules USP is lansoprazole USP, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole USP has the following structure:. Lansoprazole USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole USP is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole USP 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 USP is supplied as delayed-release capsules for oral adminsitration. The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole USP per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: ammonium hydroxide, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, propylene glycol, shellac, simethicone, starch, sucrose, sugar spheres, talc, and titanium dioxide. Components of the gelatin capsule include gelatin, iron oxide red, iron oxide yellow, FD&C Blue 2, sodium lauryl sulphate and titanium dioxide for 15 mg capsules and gelatin, iron oxide black, iron oxide red, iron oxide yellow, sodium lauryl sulphate and titanium dioxide for 30 mg capsules.</Description>
</NDC>
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<NDCCode>55111-399-30</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-399-30) </PackageDescription>
<NDC11Code>55111-0399-30</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
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<ApplicationNumber>ANDA091269</ApplicationNumber>
<LabelerName>Dr.Reddy's Laboratories Ltd.</LabelerName>
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<Status>Active</Status>
<LastUpdate>2022-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lansoprazole delayed-release capsule is a proton pump inhibitor (PPIs) indicated for the:. Treatment of active duodenal ulcer in adults. (1.1). Eradication of H. pylori to reduce the risk of duodenal ulcer. recurrence in adults. (1.2). Maintenance of healed duodenal ulcers in adults. (1.3). Treatment of active benign gastric ulcer in adults. (1.4). Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5). Risk reduction of NSAID-associated gastric ulcer in adults. (1.6). Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older.(1.7). Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8). Maintenance of healing of EE in adults. (1.9). Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).</IndicationAndUsage>
<Description>The active ingredient in lansoprazole delayed-release capsules USP is lansoprazole USP, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole USP has the following structure:. Lansoprazole USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole USP is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole USP 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 USP is supplied as delayed-release capsules for oral adminsitration. The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole USP per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: ammonium hydroxide, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, propylene glycol, shellac, simethicone, starch, sucrose, sugar spheres, talc, and titanium dioxide. Components of the gelatin capsule include gelatin, iron oxide red, iron oxide yellow, FD&C Blue 2, sodium lauryl sulphate and titanium dioxide for 15 mg capsules and gelatin, iron oxide black, iron oxide red, iron oxide yellow, sodium lauryl sulphate and titanium dioxide for 30 mg capsules.</Description>
</NDC>
<NDC>
<NDCCode>55111-399-60</NDCCode>
<PackageDescription>60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-399-60) </PackageDescription>
<NDC11Code>55111-0399-60</NDC11Code>
<ProductNDC>55111-399</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091269</ApplicationNumber>
<LabelerName>Dr.Reddy's Laboratories Ltd.</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lansoprazole delayed-release capsule is a proton pump inhibitor (PPIs) indicated for the:. Treatment of active duodenal ulcer in adults. (1.1). Eradication of H. pylori to reduce the risk of duodenal ulcer. recurrence in adults. (1.2). Maintenance of healed duodenal ulcers in adults. (1.3). Treatment of active benign gastric ulcer in adults. (1.4). Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5). Risk reduction of NSAID-associated gastric ulcer in adults. (1.6). Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older.(1.7). Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8). Maintenance of healing of EE in adults. (1.9). Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).</IndicationAndUsage>
<Description>The active ingredient in lansoprazole delayed-release capsules USP is lansoprazole USP, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole USP has the following structure:. Lansoprazole USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole USP is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole USP 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 USP is supplied as delayed-release capsules for oral adminsitration. The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole USP per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: ammonium hydroxide, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, propylene glycol, shellac, simethicone, starch, sucrose, sugar spheres, talc, and titanium dioxide. Components of the gelatin capsule include gelatin, iron oxide red, iron oxide yellow, FD&C Blue 2, sodium lauryl sulphate and titanium dioxide for 15 mg capsules and gelatin, iron oxide black, iron oxide red, iron oxide yellow, sodium lauryl sulphate and titanium dioxide for 30 mg capsules.</Description>
</NDC>
<NDC>
<NDCCode>55111-399-79</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (55111-399-79) > 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55111-0399-79</NDC11Code>
<ProductNDC>55111-399</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091269</ApplicationNumber>
<LabelerName>Dr.Reddy's Laboratories Ltd.</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lansoprazole delayed-release capsule is a proton pump inhibitor (PPIs) indicated for the:. Treatment of active duodenal ulcer in adults. (1.1). Eradication of H. pylori to reduce the risk of duodenal ulcer. recurrence in adults. (1.2). Maintenance of healed duodenal ulcers in adults. (1.3). Treatment of active benign gastric ulcer in adults. (1.4). Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5). Risk reduction of NSAID-associated gastric ulcer in adults. (1.6). Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older.(1.7). Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8). Maintenance of healing of EE in adults. (1.9). Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).</IndicationAndUsage>
<Description>The active ingredient in lansoprazole delayed-release capsules USP is lansoprazole USP, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole USP has the following structure:. Lansoprazole USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole USP is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole USP 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 USP is supplied as delayed-release capsules for oral adminsitration. The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole USP per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: ammonium hydroxide, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, propylene glycol, shellac, simethicone, starch, sucrose, sugar spheres, talc, and titanium dioxide. Components of the gelatin capsule include gelatin, iron oxide red, iron oxide yellow, FD&C Blue 2, sodium lauryl sulphate and titanium dioxide for 15 mg capsules and gelatin, iron oxide black, iron oxide red, iron oxide yellow, sodium lauryl sulphate and titanium dioxide for 30 mg capsules.</Description>
</NDC>
<NDC>
<NDCCode>55111-399-90</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-399-90) </PackageDescription>
<NDC11Code>55111-0399-90</NDC11Code>
<ProductNDC>55111-399</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091269</ApplicationNumber>
<LabelerName>Dr.Reddy's Laboratories Ltd.</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101015</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lansoprazole delayed-release capsule is a proton pump inhibitor (PPIs) indicated for the:. Treatment of active duodenal ulcer in adults. (1.1). Eradication of H. pylori to reduce the risk of duodenal ulcer. recurrence in adults. (1.2). Maintenance of healed duodenal ulcers in adults. (1.3). Treatment of active benign gastric ulcer in adults. (1.4). Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5). Risk reduction of NSAID-associated gastric ulcer in adults. (1.6). Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older.(1.7). Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8). Maintenance of healing of EE in adults. (1.9). Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).</IndicationAndUsage>
<Description>The active ingredient in lansoprazole delayed-release capsules USP is lansoprazole USP, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole USP has the following structure:. Lansoprazole USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole USP is freely soluble in dimethylformamide and practically insoluble in water. Lansoprazole USP 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 USP is supplied as delayed-release capsules for oral adminsitration. The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole USP per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: ammonium hydroxide, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, propylene glycol, shellac, simethicone, starch, sucrose, sugar spheres, talc, and titanium dioxide. Components of the gelatin capsule include gelatin, iron oxide red, iron oxide yellow, FD&C Blue 2, sodium lauryl sulphate and titanium dioxide for 15 mg capsules and gelatin, iron oxide black, iron oxide red, iron oxide yellow, sodium lauryl sulphate and titanium dioxide for 30 mg capsules.</Description>
</NDC>
<NDC>
<NDCCode>55111-399-92</NDCCode>
<PackageDescription>2500 CAPSULE, DELAYED RELEASE in 1 POUCH (55111-399-92)</PackageDescription>
<NDC11Code>55111-0399-92</NDC11Code>
<ProductNDC>55111-399</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<StartMarketingDate>20130620</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2020-02-20</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>29300-399-05</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (29300-399-05) </PackageDescription>
<NDC11Code>29300-0399-05</NDC11Code>
<ProductNDC>29300-399</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213359</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride extended-release tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white crystals or white crystalline powder with a molecular formula of C4H11N5 HCl and a molecular weight of 165.62. It is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone, and in methylene chloride. The pKa of metformin hydrochloride is 2.8 and 11.5. The pH of a 5% aqueous solution of metformin hydrochloride is between 6 and 7. Metformin hydrochloride extended-release tablets, USP contain 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin hydrochloride extended-release tablets, USP 500 mg and 750 mg contain the inactive ingredients carboxymethylcellulose sodium, hypromellose and magnesium stearate. Meets USP Dissolution Test 22.</Description>
</NDC>
<NDC>
<NDCCode>42961-399-05</NDCCode>
<PackageDescription>250 PACKET in 1 BOX (42961-399-05) / 2 TABLET in 1 PACKET (42961-399-01) </PackageDescription>
<NDC11Code>42961-0399-05</NDC11Code>
<ProductNDC>42961-399</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Xpect Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Cintas Corporation</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: headache, the common cold, backache, minor pain of arthritis, toothache, muscular aches, premenstrual and menstrual cramps. temporarily reduces fever .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43602-399-05</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43602-399-05) </PackageDescription>
<NDC11Code>43602-0399-05</NDC11Code>
<ProductNDC>43602-399</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Citrate</ProprietaryName>
<NonProprietaryName>Potassium Citrate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214420</ApplicationNumber>
<LabelerName>Ascent Pharmaceuticals Inc</LabelerName>
<SubstanceName>POTASSIUM CITRATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>meq/1</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium Citrate extended-release tablets are a citrate salt of potassium indicated for the management of: 1 Renal tubular acidosis (RTA) with calcium stones (1.1), 2 Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2), 3 Uric acid lithiasis with or without calcium stones (1.3).</IndicationAndUsage>
<Description>Potassium Citrate extended release tablets are a citrate salt of potassium. Its empirical formula is K3C6H5O7 H2O, and it has the following chemical structure. Potassium Citrate extended release tablets are off white to tan yellowish, oral wax-matrix tablets, contain 5 mEq (540 mg) potassium citrate, 10 mEq (1080 mg) potassium citrate and 15 mEq (1620 mg) potassium citrate each. Inactive ingredients include carnauba wax, silicon dioxide and magnesium stearate. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>49643-399-05</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (49643-399-05) </PackageDescription>
<NDC11Code>49643-0399-05</NDC11Code>
<ProductNDC>49643-399</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Black Cottonwood Pollen</ProprietaryName>
<NonProprietaryName>Populus Trichocarpa</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740312</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102211</ApplicationNumber>
<LabelerName>Allermed Laboratories, Inc.</LabelerName>
<SubstanceName>POPULUS TRICHOCARPA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
</NDC>
<NDC>
<NDCCode>63730-399-05</NDCCode>
<PackageDescription>100 mL in 1 CARTON (63730-399-05)</PackageDescription>
<NDC11Code>63730-0399-05</NDC11Code>
<ProductNDC>63730-399</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>The Cure Sheer Cream</ProprietaryName>
<NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170308</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Natura Bisse International</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>2; 4</StrengthNumber>
<StrengthUnit>mg/50mL; g/50mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-06-18</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68428-399-05</NDCCode>
<PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-399-05) </PackageDescription>
<NDC11Code>68428-0399-05</NDC11Code>
<ProductNDC>68428-399</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Galphimia Glauca</ProprietaryName>
<NonProprietaryName>Galphimia Glauca Flowering Top</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100215</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>GALPHIMIA GLAUCA FLOWERING TOP</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications. GALPHIMIA Sneezing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69837-399-05</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (69837-399-05) > 150 mL in 1 TUBE</PackageDescription>
<NDC11Code>69837-0399-05</NDC11Code>
<ProductNDC>69837-399</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202027</ApplicationNumber>
<LabelerName>International Brand Management, LLC</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>16.05</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Active ingredient: diclofenac sodium 16.05 mg. Excipients: alcohol (11.3%), dimethyl sulfoxide. glycerin, propylene glycol, purified water.</Description>
</NDC>
<NDC>
<NDCCode>69837-500-05</NDCCode>
<PackageDescription>1 KIT in 1 KIT (69837-500-05) * 1 TUBE in 1 KIT (69837-399-05) > 150 mL in 1 TUBE * 1 CARTON in 1 KIT > 118 g in 1 CARTON (69837-210-10)</PackageDescription>
<NDC11Code>69837-0500-05</NDC11Code>
<ProductNDC>69837-500</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sure Result Dss Premium Pak</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium, Capsaicin</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202027</ApplicationNumber>
<LabelerName>International Brand Management, LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>84525-399-05</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (84525-399-05) </PackageDescription>
<NDC11Code>84525-0399-05</NDC11Code>
<ProductNDC>84525-399</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>The Organic Avocado Anti Wrinkle Essence</ProprietaryName>
<NonProprietaryName>The Organic Avocado Anti Wrinkle Essence</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250111</StartMarketingDate>
<EndMarketingDate>20310111</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Ziqiu Import Export Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20250111</StartMarketingDatePackage>
<EndMarketingDatePackage>20310111</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84549-399-05</NDCCode>
<PackageDescription>10 mL in 1 SYRINGE (84549-399-05) </PackageDescription>
<NDC11Code>84549-0399-05</NDC11Code>
<ProductNDC>84549-399</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Procainamide Hydrochloride</ProprietaryName>
<NonProprietaryName>Procainamide Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20161221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088636</ApplicationNumber>
<LabelerName>ProPharma Distribution</LabelerName>
<SubstanceName>PROCAINAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Procainamide hydrochloride injection is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life-threatening. Because of the proarrhythmic effects of procainamide, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of procainamide treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias. Because procainamide has the potential to produce serious hematological disorders (0.5 percent) particularly leukopenia or agranulocytosis (sometimes fatal), its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment clearly outweigh the risks. (see WARNINGSand Boxed Warning.).</IndicationAndUsage>
<Description>Procainamide Hydrochloride Injection, USP, is a sterile, nonpyrogenic solution of procainamide hydrochloride in Water for Injection. It is available in 100 mg per mL concentration. The 100 mg per mL potency contains 0.9% w/v benzyl alcohol and 0.09% sodium bisulfite as preservatives. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH 5.0 (4.0 to 6.0). Headspace nitrogen gassed. Procainamide hydrochloride, a Group 1A cardiac antiarrhythmic drug, is ρ-amino-N-[2-(diethylamino) ethyl] benzamide mono-hydrochloride. It has the following structural formula. M.W. 271.79. *(locus for acetylation to N-acetyl procainamide). It differs from procaine which is the p-aminobenzoyl ester of 2-(diethylamino)-ethanol. Procainamide as the free base has a pK aof 9.23; the monohydrochloride is very soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>84756-399-05</NDCCode>
<PackageDescription>100 g in 1 BOX (84756-399-05) </PackageDescription>
<NDC11Code>84756-0399-05</NDC11Code>
<ProductNDC>84756-399</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Moisturizing Smoothes Wrinkles</ProprietaryName>
<NonProprietaryName>Trstay Moisturizing Smoothes Wrinkles</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241122</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Yiwu Luoxin E �Commerce Co Ltd</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84827-399-05</NDCCode>
<PackageDescription>100 mL in 1 BOX (84827-399-05) </PackageDescription>
<NDC11Code>84827-0399-05</NDC11Code>
<ProductNDC>84827-399</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Beard Oil Softening With Argan Oil</ProprietaryName>
<NonProprietaryName>Beard Oil Softening With Argan Oil</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241104</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Yiwu Ziqiu Import Export Co Ltd</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55111-112-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (55111-112-05) </PackageDescription>
<NDC11Code>55111-0112-05</NDC11Code>
<ProductNDC>55111-112</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Moxifloxacin</ProprietaryName>
<NonProprietaryName>Moxifloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140305</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076938</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>MOXIFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140305</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Moxifloxacin hydrochloride USP is a synthetic antibacterial agent for oral administration. Moxifloxacin, a fluoroquinolone, is available as the monohydrochloride salt of 1-cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. It is a slightly yellow to yellow powder or crystals with a molecular weight of 437.9. Its molecular formula is C21H24FN3O4*HCl and its chemical structure is as follows.</Description>
</NDC>
<NDC>
<NDCCode>55111-121-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (55111-121-05) </PackageDescription>
<NDC11Code>55111-0121-05</NDC11Code>
<ProductNDC>55111-121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120717</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091650</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.</IndicationAndUsage>
<Description>Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). The molecular formula of atorvastatin calcium is C66H68CaF2N4O10and its molecular weight is 1155.36. Its structural formula is:. Atorvastatin calcium is a white to off-white colored powder free from visible extraneous matter. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral administration contain 10, 20 and 40 mg atorvastatin and the following inactive ingredients: Basic butylated methacrylate copolymer, crospovidone, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate, methanol, microcrystalline cellulose, sodium bicarbonate and sodium lauryl sulphate. The tablet coating contains isopropyl alcohol, methylene chloride and coloring agent opadry OY-58900 white contains polyethylene glycol, titanium dioxide and hypromellose.</Description>
</NDC>
<NDC>
<NDCCode>55111-122-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (55111-122-05) </PackageDescription>
<NDC11Code>55111-0122-05</NDC11Code>
<ProductNDC>55111-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120717</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091650</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.</IndicationAndUsage>
<Description>Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). The molecular formula of atorvastatin calcium is C66H68CaF2N4O10and its molecular weight is 1155.36. Its structural formula is:. Atorvastatin calcium is a white to off-white colored powder free from visible extraneous matter. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral administration contain 10, 20 and 40 mg atorvastatin and the following inactive ingredients: Basic butylated methacrylate copolymer, crospovidone, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate, methanol, microcrystalline cellulose, sodium bicarbonate and sodium lauryl sulphate. The tablet coating contains isopropyl alcohol, methylene chloride and coloring agent opadry OY-58900 white contains polyethylene glycol, titanium dioxide and hypromellose.</Description>
</NDC>
<NDC>
<NDCCode>55111-123-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (55111-123-05) </PackageDescription>
<NDC11Code>55111-0123-05</NDC11Code>
<ProductNDC>55111-123</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120717</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091650</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.</IndicationAndUsage>
<Description>Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). The molecular formula of atorvastatin calcium is C66H68CaF2N4O10and its molecular weight is 1155.36. Its structural formula is:. Atorvastatin calcium is a white to off-white colored powder free from visible extraneous matter. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral administration contain 10, 20 and 40 mg atorvastatin and the following inactive ingredients: Basic butylated methacrylate copolymer, crospovidone, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate, methanol, microcrystalline cellulose, sodium bicarbonate and sodium lauryl sulphate. The tablet coating contains isopropyl alcohol, methylene chloride and coloring agent opadry OY-58900 white contains polyethylene glycol, titanium dioxide and hypromellose.</Description>
</NDC>
<NDC>
<NDCCode>55111-124-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (55111-124-05) </PackageDescription>
<NDC11Code>55111-0124-05</NDC11Code>
<ProductNDC>55111-124</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120717</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202357</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-12-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.</IndicationAndUsage>
<Description>Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1). The molecular formula of atorvastatin calcium is C66H68CaF2N4O10and its molecular weight is 1155.36. Its structural formula is:. Atorvastatin calcium is a white to off-white colored powder free from visible extraneous matter. Atorvastatin calcium is soluble in dimethyl sulphoxide, slightly soluble in alcohol, very slightly soluble in water, in pH 7.4 phosphate buffer and in acetonitrile and practically insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral administration contain 80 mg atorvastatin and the following inactive ingredients: Basic butylated methacrylate copolymer, crospovidone, hydroxy propyl cellulose, lactose monohydrate, magnesium stearate, methanol, microcrystalline cellulose, sodium bicarbonate and sodium lauryl sulphate. The tablet coating contains lecithin, polyvinyl alcohol, talc, titanium dioxide, and xanthan gum. Atorvastatin calcium tablets meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-126-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (55111-126-05) </PackageDescription>
<NDC11Code>55111-0126-05</NDC11Code>
<ProductNDC>55111-126</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040609</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075593</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Ciprofloxacin tablets USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydratesalt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid.It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 100 mg, 250 mg, 500 mg and 750 strengths. Each ciprofloxacin film-coated tablet contains 100 mg (equivalent to 116.4 mg ciprofloxacin hydrochloride monohydrate) or 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets are white. The inactive ingredients are colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate, and titanium dioxide.</Description>
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<NDCCode>55111-127-05</NDCCode>
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<NDC11Code>55111-0127-05</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075593</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-07</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Ciprofloxacin tablets USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydratesalt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid.It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 100 mg, 250 mg, 500 mg and 750 strengths. Each ciprofloxacin film-coated tablet contains 100 mg (equivalent to 116.4 mg ciprofloxacin hydrochloride monohydrate) or 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets are white. The inactive ingredients are colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55111-128-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (55111-128-05) </PackageDescription>
<NDC11Code>55111-0128-05</NDC11Code>
<ProductNDC>55111-128</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20040609</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075593</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Ciprofloxacin tablets USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydratesalt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid.It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its molecular formula is C17H18FN3O3HClH2O and its chemical structure is as follows. Ciprofloxacin film-coated tablets are available in 100 mg, 250 mg, 500 mg and 750 strengths. Each ciprofloxacin film-coated tablet contains 100 mg (equivalent to 116.4 mg ciprofloxacin hydrochloride monohydrate) or 250 mg (equivalent to 291 mg ciprofloxacin hydrochloride monohydrate) or 500 mg of ciprofloxacin (equivalent to 582 mg ciprofloxacin hydrochloride monohydrate) or 750 mg of ciprofloxacin (equivalent to 873 mg ciprofloxacin hydrochloride monohydrate). Ciprofloxacin tablets are white. The inactive ingredients are colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55111-129-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (55111-129-05) </PackageDescription>
<NDC11Code>55111-0129-05</NDC11Code>
<ProductNDC>55111-129</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ranitidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Ranitidine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010112</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075742</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2018-11-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ranitidine is indicated in:. 1. Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. 2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year. 3.The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis). 4. Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks. 5.Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year. 6.Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg two times a day. 7. Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg 4 times daily. 8. Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks. Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.</IndicationAndUsage>
<Description>Ranitidine hydrochloride (HCl) USP, is a histamine H2-receptor antagonist. Chemically it is N-[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N’-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structural formula. The molecular formula is C13H22N4O3SHCl, representing a molecular weight of 350.87. Ranitidine hydrochloride USP is a white to pale yellow, crystalline practically odorless powder, is sensitive to light and moisture. It is very soluble in water and sparingly soluble in alcohol. Each Ranitidine Hydrochloride capsule, for oral administration, contains 167.4 mg or 334.8 mg of ranitidine hydrochloride equivalent to 150 mg or 300 mg of ranitidine, respectively. In addition, each capsule contains the following inactive ingredients: Microcrystalline Cellulose, Sodium Starch Glycolate, Magnesium Stearate. The capsule shells contain Black Iron Oxide, Red Iron Oxide T3469, Yellow Iron Oxide T3506, Titanium Dioxide and Gelatin. The capsule shells are imprinted with edible ink.</Description>
</NDC>
<NDC>
<NDCCode>55111-143-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (55111-143-05) </PackageDescription>
<NDC11Code>55111-0143-05</NDC11Code>
<ProductNDC>55111-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076658</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of:. 1. Vaginal candidiasis (vaginal yeast infections due to Candida). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.</IndicationAndUsage>
<Description>Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder, which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropyl alcohol and in chloroform. Slightly soluble in water, very slightly soluble in toluene. Fluconazole tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: dibasic calcium phosphate anhydrous, ferric oxide (iron oxide, red), magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and starch. Fluconazole tablets meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-144-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (55111-144-05) </PackageDescription>
<NDC11Code>55111-0144-05</NDC11Code>
<ProductNDC>55111-144</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076658</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of:. 1. Vaginal candidiasis (vaginal yeast infections due to Candida). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.</IndicationAndUsage>
<Description>Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder, which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropyl alcohol and in chloroform. Slightly soluble in water, very slightly soluble in toluene. Fluconazole tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: dibasic calcium phosphate anhydrous, ferric oxide (iron oxide, red), magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and starch. Fluconazole tablets meets USP Dissolution Test 2.</Description>
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