{
"NDC": [
{
"NDCCode": "69238-2078-7",
"PackageDescription": "1000 TABLET in 1 BOTTLE (69238-2078-7) ",
"NDC11Code": "69238-2078-07",
"ProductNDC": "69238-2078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071972",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210603",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension. Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride is not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis. Propranolol hydrochloride tablets are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation. Propranolol hydrochloride tablets are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Myocardial Infarction. Propranolol is indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Migraine. Propranolol is indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Essential Tremor. Propranolol is indicated in the management of familial or hereditary essential tremor. Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest, but occurs when the limb is held in a fixed posture or position against gravity and during active movement. Propranolol causes a reduction in the tremor amplitude, but not in the tremor frequency. Propranolol is not indicated for the treatment of tremor associated with Parkinsonism. Hypertrophic Subaortic Stenosis. Propranolol improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Pheochromocytoma. Propranolol is indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.",
"Description": "Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its structural formula is. Propranolol hydrochloride, USP is a stable, white to off-white, crystalline powder which is readily soluble in water and ethanol. Propranolol Hydrochloride Tablets, USP are available as tablets for oral administration containing either 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg of propranolol hydrochloride, USP. Propranolol Hydrochloride Tablets, USP also contain lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Color additives include FD&C Yellow No. 6 aluminum lake (10 mg and 80 mg), D&C Yellow No. 10 aluminum lake (10 mg, 40 mg, and 80 mg), FD&C Blue No. 1 aluminum lake (20 mg and 40 mg) and FD&C Red No. 40 aluminum lake (60 mg)."
},
{
"NDCCode": "69238-2078-1",
"PackageDescription": "100 TABLET in 1 BOTTLE (69238-2078-1) ",
"NDC11Code": "69238-2078-01",
"ProductNDC": "69238-2078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071972",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210603",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension. Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride is not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis. Propranolol hydrochloride tablets are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation. Propranolol hydrochloride tablets are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Myocardial Infarction. Propranolol is indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Migraine. Propranolol is indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Essential Tremor. Propranolol is indicated in the management of familial or hereditary essential tremor. Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest, but occurs when the limb is held in a fixed posture or position against gravity and during active movement. Propranolol causes a reduction in the tremor amplitude, but not in the tremor frequency. Propranolol is not indicated for the treatment of tremor associated with Parkinsonism. Hypertrophic Subaortic Stenosis. Propranolol improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Pheochromocytoma. Propranolol is indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.",
"Description": "Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its structural formula is. Propranolol hydrochloride, USP is a stable, white to off-white, crystalline powder which is readily soluble in water and ethanol. Propranolol Hydrochloride Tablets, USP are available as tablets for oral administration containing either 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg of propranolol hydrochloride, USP. Propranolol Hydrochloride Tablets, USP also contain lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Color additives include FD&C Yellow No. 6 aluminum lake (10 mg and 80 mg), D&C Yellow No. 10 aluminum lake (10 mg, 40 mg, and 80 mg), FD&C Blue No. 1 aluminum lake (20 mg and 40 mg) and FD&C Red No. 40 aluminum lake (60 mg)."
},
{
"NDCCode": "58228-2078-1",
"PackageDescription": "1000 BOX in 1 CASE (58228-2078-1) / 10 POUCH in 1 BOX / .55 mL in 1 POUCH",
"NDC11Code": "58228-2078-01",
"ProductNDC": "58228-2078",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alcohol Wipes",
"NonProprietaryName": "Alcohol Wipes",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240108",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "ProStat First Aid LLC",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Active",
"LastUpdate": "2025-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240108",
"SamplePackage": "N",
"IndicationAndUsage": " First aid to help prevent infection in minor cuts, scrapes, and burns. For preparation of the skin prior to an injection."
},
{
"NDCCode": "70710-2078-2",
"PackageDescription": "2 SYRINGE, PLASTIC in 1 PACKAGE (70710-2078-2) / .5 mL in 1 SYRINGE, PLASTIC",
"NDC11Code": "70710-2078-02",
"ProductNDC": "70710-2078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diazepam",
"NonProprietaryName": "Diazepam",
"DosageFormName": "GEL",
"RouteName": "RECTAL",
"StartMarketingDate": "20251215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217468",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "DIAZEPAM",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251215",
"SamplePackage": "N",
"IndicationAndUsage": "Diazepam rectal gel is intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 2 years of age and older.",
"Description": "Diazepam rectal gel rectal delivery system is a non-sterile diazepam gel provided in a prefilled, unit-dose, rectal delivery system. Diazepam rectal gel contains 5 mg/mL diazepam, benzoic acid, benzyl alcohol (1.5%), ethyl alcohol (10%), hydroxypropyl methylcellulose, propylene glycol, purified water, and sodium benzoate. Diazepam rectal gel is clear, colorless to yellow and has a pH between 6.5-7.2. Diazepam, the active ingredient of diazepam rectal gel, is a benzodiazepine anticonvulsant with the chemical name 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. The structural formula is as follows."
},
{
"NDCCode": "71335-2078-1",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2078-1) ",
"NDC11Code": "71335-2078-01",
"ProductNDC": "71335-2078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205868",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220425",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules are proton pump inhibitors (PPIs) indicated for the: : 1 Treatment of active duodenal ulcer in adults( 1.1) , 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults ( 1.2) , 3 Maintenance of healed duodenal ulcers in adults ( 1.3) , 4 Treatment of active benign gastric ulcer in adults ( 1.4) , 5 Healing of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults ( 1.5) , 6 Risk reduction of NSAID-associated gastric ulcer in adults( 1.6) , 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older ( 1.7) , 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older ( 1.8) , 9 Maintenance of healing of EE in adults.( 1.9) , 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults ( 1.10) .",
"Description": "The active ingredient in Lansoprazole Delayed-Release 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 C 16H 14F 3N 3O 2S with a molecular weight of 369.37. Lansoprazole has the following structure:. Lansoprazole USP is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and 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 is supplied in delayed-release capsules, USP for oral administration. Lansoprazole delayed-release capsules,USP are available in two dosage strengths: 15 mg and 30 mg of lansoprazole USP per capsule. Each delayed-release capsule contains enteric-coated pellets consisting of 15 mg or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: corn starch, gelatin, hydroxypropyl cellulose, magnesium carbonate, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, sucrose, sugar spheres, talc, titanium dioxide, FD&C Blue 2 1, Iron oxide yellow 1, Iron oxide black 2. 1 Lansoprazole delayed-release capsules, USP 15 mg only. 2 Lansoprazole delayed-release capsules, USP 30 mg only."
},
{
"NDCCode": "71335-2078-2",
"PackageDescription": "15 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2078-2) ",
"NDC11Code": "71335-2078-02",
"ProductNDC": "71335-2078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205868",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220425",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules are proton pump inhibitors (PPIs) indicated for the: : 1 Treatment of active duodenal ulcer in adults( 1.1) , 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults ( 1.2) , 3 Maintenance of healed duodenal ulcers in adults ( 1.3) , 4 Treatment of active benign gastric ulcer in adults ( 1.4) , 5 Healing of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults ( 1.5) , 6 Risk reduction of NSAID-associated gastric ulcer in adults( 1.6) , 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older ( 1.7) , 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older ( 1.8) , 9 Maintenance of healing of EE in adults.( 1.9) , 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults ( 1.10) .",
"Description": "The active ingredient in Lansoprazole Delayed-Release 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 C 16H 14F 3N 3O 2S with a molecular weight of 369.37. Lansoprazole has the following structure:. Lansoprazole USP is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and 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 is supplied in delayed-release capsules, USP for oral administration. Lansoprazole delayed-release capsules,USP are available in two dosage strengths: 15 mg and 30 mg of lansoprazole USP per capsule. Each delayed-release capsule contains enteric-coated pellets consisting of 15 mg or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: corn starch, gelatin, hydroxypropyl cellulose, magnesium carbonate, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, sucrose, sugar spheres, talc, titanium dioxide, FD&C Blue 2 1, Iron oxide yellow 1, Iron oxide black 2. 1 Lansoprazole delayed-release capsules, USP 15 mg only. 2 Lansoprazole delayed-release capsules, USP 30 mg only."
},
{
"NDCCode": "71335-2078-3",
"PackageDescription": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2078-3) ",
"NDC11Code": "71335-2078-03",
"ProductNDC": "71335-2078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205868",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220425",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules are proton pump inhibitors (PPIs) indicated for the: : 1 Treatment of active duodenal ulcer in adults( 1.1) , 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults ( 1.2) , 3 Maintenance of healed duodenal ulcers in adults ( 1.3) , 4 Treatment of active benign gastric ulcer in adults ( 1.4) , 5 Healing of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults ( 1.5) , 6 Risk reduction of NSAID-associated gastric ulcer in adults( 1.6) , 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older ( 1.7) , 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older ( 1.8) , 9 Maintenance of healing of EE in adults.( 1.9) , 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults ( 1.10) .",
"Description": "The active ingredient in Lansoprazole Delayed-Release 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 C 16H 14F 3N 3O 2S with a molecular weight of 369.37. Lansoprazole has the following structure:. Lansoprazole USP is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and 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 is supplied in delayed-release capsules, USP for oral administration. Lansoprazole delayed-release capsules,USP are available in two dosage strengths: 15 mg and 30 mg of lansoprazole USP per capsule. Each delayed-release capsule contains enteric-coated pellets consisting of 15 mg or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: corn starch, gelatin, hydroxypropyl cellulose, magnesium carbonate, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, sucrose, sugar spheres, talc, titanium dioxide, FD&C Blue 2 1, Iron oxide yellow 1, Iron oxide black 2. 1 Lansoprazole delayed-release capsules, USP 15 mg only. 2 Lansoprazole delayed-release capsules, USP 30 mg only."
},
{
"NDCCode": "71335-2078-4",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2078-4) ",
"NDC11Code": "71335-2078-04",
"ProductNDC": "71335-2078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205868",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220425",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules are proton pump inhibitors (PPIs) indicated for the: : 1 Treatment of active duodenal ulcer in adults( 1.1) , 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults ( 1.2) , 3 Maintenance of healed duodenal ulcers in adults ( 1.3) , 4 Treatment of active benign gastric ulcer in adults ( 1.4) , 5 Healing of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults ( 1.5) , 6 Risk reduction of NSAID-associated gastric ulcer in adults( 1.6) , 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older ( 1.7) , 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older ( 1.8) , 9 Maintenance of healing of EE in adults.( 1.9) , 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults ( 1.10) .",
"Description": "The active ingredient in Lansoprazole Delayed-Release 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 C 16H 14F 3N 3O 2S with a molecular weight of 369.37. Lansoprazole has the following structure:. Lansoprazole USP is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and 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 is supplied in delayed-release capsules, USP for oral administration. Lansoprazole delayed-release capsules,USP are available in two dosage strengths: 15 mg and 30 mg of lansoprazole USP per capsule. Each delayed-release capsule contains enteric-coated pellets consisting of 15 mg or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: corn starch, gelatin, hydroxypropyl cellulose, magnesium carbonate, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, sucrose, sugar spheres, talc, titanium dioxide, FD&C Blue 2 1, Iron oxide yellow 1, Iron oxide black 2. 1 Lansoprazole delayed-release capsules, USP 15 mg only. 2 Lansoprazole delayed-release capsules, USP 30 mg only."
},
{
"NDCCode": "71335-2078-5",
"PackageDescription": "28 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2078-5) ",
"NDC11Code": "71335-2078-05",
"ProductNDC": "71335-2078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205868",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220425",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules are proton pump inhibitors (PPIs) indicated for the: : 1 Treatment of active duodenal ulcer in adults( 1.1) , 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults ( 1.2) , 3 Maintenance of healed duodenal ulcers in adults ( 1.3) , 4 Treatment of active benign gastric ulcer in adults ( 1.4) , 5 Healing of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults ( 1.5) , 6 Risk reduction of NSAID-associated gastric ulcer in adults( 1.6) , 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older ( 1.7) , 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older ( 1.8) , 9 Maintenance of healing of EE in adults.( 1.9) , 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults ( 1.10) .",
"Description": "The active ingredient in Lansoprazole Delayed-Release 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 C 16H 14F 3N 3O 2S with a molecular weight of 369.37. Lansoprazole has the following structure:. Lansoprazole USP is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and 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 is supplied in delayed-release capsules, USP for oral administration. Lansoprazole delayed-release capsules,USP are available in two dosage strengths: 15 mg and 30 mg of lansoprazole USP per capsule. Each delayed-release capsule contains enteric-coated pellets consisting of 15 mg or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: corn starch, gelatin, hydroxypropyl cellulose, magnesium carbonate, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, sucrose, sugar spheres, talc, titanium dioxide, FD&C Blue 2 1, Iron oxide yellow 1, Iron oxide black 2. 1 Lansoprazole delayed-release capsules, USP 15 mg only. 2 Lansoprazole delayed-release capsules, USP 30 mg only."
},
{
"NDCCode": "69238-1031-7",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (69238-1031-7) / 1 KIT in 1 BLISTER PACK (69238-1031-6) ",
"NDC11Code": "69238-1031-07",
"ProductNDC": "69238-1031",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Melodetta 24 Fe",
"NonProprietaryName": "Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate",
"DosageFormName": "KIT",
"StartMarketingDate": "20170921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207514",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"Status": "Active",
"LastUpdate": "2023-07-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170921",
"SamplePackage": "N",
"IndicationAndUsage": "Melodetta 24 Fe is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)]. The efficacy of Melodetta 24 Fe in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.",
"Description": "Melodetta 24 Fe provides an oral contraceptive regimen consisting of 24 white active chewable tablets that contain the active ingredients, followed by 4 brown non-hormonal placebo tablets as specified below: : 1 24 white, round tablets each containing 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP. , 2 4 brown, round tablets each containing 75 mg ferrous fumarate. ."
},
{
"NDCCode": "69238-1065-7",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (69238-1065-7) ",
"NDC11Code": "69238-1065-07",
"ProductNDC": "69238-1065",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200511",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212861",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200511",
"SamplePackage": "N",
"IndicationAndUsage": "BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia., 2 For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias. .",
"Description": "The Potassium Chloride Extended-Release Tablets USP, 20 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. The Potassium Chloride Extended-Release Tablets USP, 15 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,125 mg of microencapsulated potassium chloride, USP equivalent to 15 mEq of potassium in a tablet. The Potassium Chloride Extended-Release Tablets USP, 10 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium Chloride is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Its molecular weight is 74.55 g/mole. Potassium chloride, USP occurs as a white to off-white, crystalline, granular powder. It is freely soluble in water and insoluble in alcohol. Potassium Chloride is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of out-side agitation, potassium chloride tablets begin disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride. Inactive Ingredients: croscarmellose sodium, ethyl cellulose, microcrystalline cellulose and triethyl citrate. Meets USP Dissolution Test 7."
},
{
"NDCCode": "69238-1165-7",
"PackageDescription": "120 TABLET in 1 BOTTLE (69238-1165-7) ",
"NDC11Code": "69238-1165-07",
"ProductNDC": "69238-1165",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abiraterone Acetate",
"NonProprietaryName": "Abiraterone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208327",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "ABIRATERONE ACETATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190107",
"SamplePackage": "N",
"IndicationAndUsage": "Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with : 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).",
"Description": "Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg uncoated tablets and 500 mg film-coated tablets with the following inactive ingredients: : 1 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate., 2 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating, Opadry® II Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. ."
},
{
"NDCCode": "69238-1293-7",
"PackageDescription": "8 POUCH in 1 CARTON (69238-1293-7) / 1 d in 1 POUCH (69238-1293-1) ",
"NDC11Code": "69238-1293-07",
"ProductNDC": "69238-1293",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20200930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211396",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".0375",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200930",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system is indicated for.",
"Description": "Estradiol transdermal system USP, contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system, USP are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol, USP is C18H2402. The molecular weight is 272.39. Estradiol transdermal system USP, is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. Meets USP Drug Release Test 6."
},
{
"NDCCode": "69238-1294-7",
"PackageDescription": "8 POUCH in 1 CARTON (69238-1294-7) / 1 d in 1 POUCH (69238-1294-1) ",
"NDC11Code": "69238-1294-07",
"ProductNDC": "69238-1294",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20200930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211396",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".075",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200930",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system is indicated for.",
"Description": "Estradiol transdermal system USP, contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system, USP are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol, USP is C18H2402. The molecular weight is 272.39. Estradiol transdermal system USP, is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. Meets USP Drug Release Test 6."
},
{
"NDCCode": "69238-1295-7",
"PackageDescription": "8 POUCH in 1 CARTON (69238-1295-7) / 1 d in 1 POUCH (69238-1295-1) ",
"NDC11Code": "69238-1295-07",
"ProductNDC": "69238-1295",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20200930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211396",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".05",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200930",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system is indicated for.",
"Description": "Estradiol transdermal system USP, contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system, USP are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol, USP is C18H2402. The molecular weight is 272.39. Estradiol transdermal system USP, is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. Meets USP Drug Release Test 6."
},
{
"NDCCode": "69238-1296-7",
"PackageDescription": "8 POUCH in 1 CARTON (69238-1296-7) / 1 d in 1 POUCH (69238-1296-1) ",
"NDC11Code": "69238-1296-07",
"ProductNDC": "69238-1296",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20200930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211396",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".1",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200930",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system is indicated for.",
"Description": "Estradiol transdermal system USP, contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system, USP are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol, USP is C18H2402. The molecular weight is 272.39. Estradiol transdermal system USP, is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. Meets USP Drug Release Test 6."
},
{
"NDCCode": "69238-1308-7",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (69238-1308-7) / 10 TABLET, FILM COATED in 1 BLISTER PACK (69238-1308-1) ",
"NDC11Code": "69238-1308-07",
"ProductNDC": "69238-1308",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solifenacin Succinate",
"NonProprietaryName": "Solifenacin Succinate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209719",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "SOLIFENACIN SUCCINATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190520",
"SamplePackage": "N",
"IndicationAndUsage": "Solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
"Description": "Solifenacin succinate is a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)-iso-quinolinecarboxylate (1:1) having a molecular formula of C23H26N2O2C4H6O4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each solifenacin succinate tablet contains 5 mg or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inactive ingredients: butylated hydroxyanisole, corn starch, hypromellose, iron oxide yellow (5 mg), iron oxide red (10 mg), lactose monohydrate, magnesium stearate, polyethylene glycol, propyl gallate, titanium dioxide, talc and tartaric acid."
},
{
"NDCCode": "69238-1309-7",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (69238-1309-7) / 10 TABLET, FILM COATED in 1 BLISTER PACK (69238-1309-1) ",
"NDC11Code": "69238-1309-07",
"ProductNDC": "69238-1309",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solifenacin Succinate",
"NonProprietaryName": "Solifenacin Succinate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209719",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "SOLIFENACIN SUCCINATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190520",
"SamplePackage": "N",
"IndicationAndUsage": "Solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.",
"Description": "Solifenacin succinate is a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)-iso-quinolinecarboxylate (1:1) having a molecular formula of C23H26N2O2C4H6O4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each solifenacin succinate tablet contains 5 mg or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inactive ingredients: butylated hydroxyanisole, corn starch, hypromellose, iron oxide yellow (5 mg), iron oxide red (10 mg), lactose monohydrate, magnesium stearate, polyethylene glycol, propyl gallate, titanium dioxide, talc and tartaric acid."
},
{
"NDCCode": "69238-1447-7",
"PackageDescription": "8 POUCH in 1 CARTON (69238-1447-7) / 1 d in 1 POUCH (69238-1447-1) ",
"NDC11Code": "69238-1447-07",
"ProductNDC": "69238-1447",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20200930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211396",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".025",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200930",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system is indicated for.",
"Description": "Estradiol transdermal system USP, contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system, USP are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol, USP is C18H2402. The molecular weight is 272.39. Estradiol transdermal system USP, is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. Meets USP Drug Release Test 6."
},
{
"NDCCode": "69238-1521-3",
"PackageDescription": "3 POUCH in 1 CARTON (69238-1521-3) / 1 PATCH in 1 POUCH (69238-1521-1) / 7 d in 1 PATCH",
"NDC11Code": "69238-1521-03",
"ProductNDC": "69238-1521",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Norelgestromin And Ethinly Estradiol",
"NonProprietaryName": "Norelgestromin And Ethinly Estradiol",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20210226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213950",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "NORELGESTROMIN; ETHINYL ESTRADIOL",
"StrengthNumber": "150; 35",
"StrengthUnit": "ug/d; ug/d",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210226",
"SamplePackage": "N",
"IndicationAndUsage": "Norelgestromin and ethinyl estradiol transdermal system is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate. Limitations of Use:. Norelgestromin and ethinyl estradiol transdermal system may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more. Norelgestromin and ethinyl estradiol transdermal system is contraindicated for use in women with BMI ≥ 30 kg/m2 [see Contraindications (4), Warnings and Precautions (5.1) and Clinical Studies (14)].",
"Description": "Norelgestromin and ethinyl estradiol transdermal system has a contact surface area of 12.5 cm2. It contains 3.15 mg norelgestromin, USP (NGMN) and 0.289 mg ethinyl estradiol, USP (EE), and its delivery rate is approximately 150 mcg of NGMN, USP and 35 mcg of EE, USP per day. Systemic exposures (as measured by area under the curve [AUC] and steady-state concentration [Css]) of NGMN, USP and EE, USP during use of norelgestromin and ethinyl estradiol transdermal system are higher and the Cmax is lower than those produced by an oral contraceptive containing norgestimate, USP (NGM) 250 mcg / EE, USP 35 mcg [see Boxed Warning and Clinical Pharmacology (12.3)]. Norelgestromin and ethinyl estradiol transdermal system is a thin, matrix-type transdermal system consisting of three layers. The backing layer is composed of a tan backing consisting of pigmented polyethylene and polyester. It provides structural support and protects the middle adhesive layer from the environment. The middle layer contains polyisobutylene/polybutene adhesive, polybutene, crospovidone, oleyl alcohol and dipropylene glycol as inactive components. The active components in this layer are the hormones, NGMN, USP and EE, USP. The third layer is the release liner, which protects the adhesive layer during storage and is removed just prior to application. It is a transparent polyethylene terephthalate (PET) film with a silicone coating on the side that is in contact with the middle adhesive layer. The outside of the backing layer is printed with “Norelgestromin and Ethinyl Estradiol 150/35 mcg per day” in brown ink. The structural formulas of the components are. Norelgestromin, USP ethinyl estradiol, USP. Molecular weight, NGMN, USP: 327.47. Molecular weight, EE, USP: 296.41. Chemical name for NGMN, USP: 18, 19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-,3-oxime,(17α). Chemical name for EE, USP: 19-Norpregna-1,3,5(10)-trien-20-yne-3, 17-diol,(17α)."
},
{
"NDCCode": "69238-1524-7",
"PackageDescription": "8 APPLICATOR in 1 CARTON (69238-1524-7) > 1 TABLET in 1 APPLICATOR",
"NDC11Code": "69238-1524-07",
"ProductNDC": "69238-1524",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Yuvafem",
"NonProprietaryName": "Estradiol",
"DosageFormName": "TABLET",
"RouteName": "VAGINAL",
"StartMarketingDate": "20160201",
"EndMarketingDate": "20200401",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020908",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "ESTRADIOL HEMIHYDRATE",
"StrengthNumber": "10",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160201",
"EndMarketingDatePackage": "20200401",
"SamplePackage": "N"
},
{
"NDCCode": "69238-1629-7",
"PackageDescription": "8 POUCH in 1 CARTON (69238-1629-7) / 1 d in 1 POUCH (69238-1629-1) ",
"NDC11Code": "69238-1629-07",
"ProductNDC": "69238-1629",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20190204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211293",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".025",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190204",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system is indicated for.",
"Description": "Estradiol transdermal system, USP contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system, USP are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)- triene-3,17β-diol. The structural formula is. The molecular formula of estradiol, USP is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system, USP is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. FDA approved acceptance criteria for dissolution test specifications differ from USP."
},
{
"NDCCode": "69238-1630-7",
"PackageDescription": "8 POUCH in 1 CARTON (69238-1630-7) / 1 d in 1 POUCH (69238-1630-1) ",
"NDC11Code": "69238-1630-07",
"ProductNDC": "69238-1630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20190204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211293",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".0375",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190204",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system is indicated for.",
"Description": "Estradiol transdermal system, USP contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system, USP are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)- triene-3,17β-diol. The structural formula is. The molecular formula of estradiol, USP is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system, USP is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. FDA approved acceptance criteria for dissolution test specifications differ from USP."
},
{
"NDCCode": "69238-1631-7",
"PackageDescription": "8 POUCH in 1 CARTON (69238-1631-7) / 1 d in 1 POUCH (69238-1631-1) ",
"NDC11Code": "69238-1631-07",
"ProductNDC": "69238-1631",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20190204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211293",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".05",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190204",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system is indicated for.",
"Description": "Estradiol transdermal system, USP contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system, USP are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)- triene-3,17β-diol. The structural formula is. The molecular formula of estradiol, USP is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system, USP is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. FDA approved acceptance criteria for dissolution test specifications differ from USP."
},
{
"NDCCode": "69238-1632-7",
"PackageDescription": "8 POUCH in 1 CARTON (69238-1632-7) / 1 d in 1 POUCH (69238-1632-1) ",
"NDC11Code": "69238-1632-07",
"ProductNDC": "69238-1632",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20190204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211293",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".075",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190204",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system is indicated for.",
"Description": "Estradiol transdermal system, USP contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system, USP are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)- triene-3,17β-diol. The structural formula is. The molecular formula of estradiol, USP is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system, USP is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. FDA approved acceptance criteria for dissolution test specifications differ from USP."
},
{
"NDCCode": "69238-1633-7",
"PackageDescription": "8 POUCH in 1 CARTON (69238-1633-7) / 1 d in 1 POUCH (69238-1633-1) ",
"NDC11Code": "69238-1633-07",
"ProductNDC": "69238-1633",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20190204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211293",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".1",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190204",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system is indicated for.",
"Description": "Estradiol transdermal system, USP contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system, USP are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)- triene-3,17β-diol. The structural formula is. The molecular formula of estradiol, USP is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system, USP is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. FDA approved acceptance criteria for dissolution test specifications differ from USP."
},
{
"NDCCode": "69238-1642-7",
"PackageDescription": "1 BOTTLE in 1 CARTON (69238-1642-7) / 270 CAPSULE in 1 BOTTLE",
"NDC11Code": "69238-1642-07",
"ProductNDC": "69238-1642",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pirfenidone",
"NonProprietaryName": "Pirfenidone",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220107",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212569",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "PIRFENIDONE",
"StrengthNumber": "267",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Pyridone [EPC], Pyridones [CS]",
"Status": "Active",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220107",
"SamplePackage": "N",
"IndicationAndUsage": "Pirfenidone capsules are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).",
"Description": "Pirfenidone, USP belongs to the chemical class of pyridone. Pirfenidone capsules, USP are available as a opaque white to off-white hard gelatin capsule containing 267 mg of pirfenidone, USP for oral administration. Pirfenidone, USP has a molecular formula of C12H11NO and a molecular weight of 185.22 g/mol. Pirfenidone, USP has the following structural formula, which has been referred to as 5-methyl-1-phenylpyridin-2-one. Pirfenidone, USP is a white to pale yellow, non-hygroscopic, crystalline powder. It is sparingly soluble in water, freely soluble in ethanol (96%), and slightly soluble in heptane. The melting point range is 107°C to 111°C. Each pirfenidone capsule, USP contains pirfenidone USP, 267 mg as active ingredient and the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, and magnesium stearate. In addition, the capsule shell contains gelatin and titanium dioxide. The capsule is imprinted with black pharmaceutical ink which includes butyl alcohol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution."
},
{
"NDCCode": "69238-1720-7",
"PackageDescription": "120 TABLET in 1 BOTTLE, PLASTIC (69238-1720-7) ",
"NDC11Code": "69238-1720-07",
"ProductNDC": "69238-1720",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etravirine",
"NonProprietaryName": "Etravirine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214196",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "ETRAVIRINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210614",
"SamplePackage": "N"
},
{
"NDCCode": "69238-1721-7",
"PackageDescription": "120 TABLET in 1 BOTTLE, PLASTIC (69238-1721-7) ",
"NDC11Code": "69238-1721-07",
"ProductNDC": "69238-1721",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etravirine",
"NonProprietaryName": "Etravirine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214196",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "ETRAVIRINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210614",
"SamplePackage": "N"
},
{
"NDCCode": "69238-1729-7",
"PackageDescription": "1 BOTTLE in 1 CARTON (69238-1729-7) / 150 mL in 1 BOTTLE",
"NDC11Code": "69238-1729-07",
"ProductNDC": "69238-1729",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enalapril Maleate",
"NonProprietaryName": "Enalapril",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20191201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212894",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "ENALAPRIL MALEATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]",
"Status": "Active",
"LastUpdate": "2024-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191201",
"SamplePackage": "N",
"IndicationAndUsage": "Enalapril maleate oral solution is an angiotensin-converting enzyme inhibitor indicated for: : 1 treatment of hypertension in adults and children older than one month, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) , 2 treatment of symptomatic heart failure. (1.2) , 3 treatment of asymptomatic left ventricular dysfunction, to decrease the rate of development of overt heart failure and reduce hospitalization for heart failure. (1.3) .",
"Description": "Enalapril maleate (enalapril maleate) oral solution is the maleate salt of enalapril, the ethyl ester prodrug of a long-acting angiotensin-converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C20H28N2O5C4H4O4, and its structural formula is. Enalapril maleate is an off-white, crystalline powder with a molecular weight of 492.52. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril maleate oral solution is a ready-to-use oral solution. Each 1 mL contains 1 mg of enalapril maleate, USP equivalent to 0.764 mg of enalapril. Inactive ingredients include artificial juicy raspberry flavor, malic acid, purified water, sodium benzoate, and sucralose. Enalapril maleate oral solution is clear and colorless."
}
]
}
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<NDC>
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<PackageDescription>1000 TABLET in 1 BOTTLE (69238-2078-7) </PackageDescription>
<NDC11Code>69238-2078-07</NDC11Code>
<ProductNDC>69238-2078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
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<IndicationAndUsage>Hypertension. Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride is not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis. Propranolol hydrochloride tablets are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation. Propranolol hydrochloride tablets are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Myocardial Infarction. Propranolol is indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Migraine. Propranolol is indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Essential Tremor. Propranolol is indicated in the management of familial or hereditary essential tremor. Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest, but occurs when the limb is held in a fixed posture or position against gravity and during active movement. Propranolol causes a reduction in the tremor amplitude, but not in the tremor frequency. Propranolol is not indicated for the treatment of tremor associated with Parkinsonism. Hypertrophic Subaortic Stenosis. Propranolol improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Pheochromocytoma. Propranolol is indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.</IndicationAndUsage>
<Description>Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its structural formula is. Propranolol hydrochloride, USP is a stable, white to off-white, crystalline powder which is readily soluble in water and ethanol. Propranolol Hydrochloride Tablets, USP are available as tablets for oral administration containing either 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg of propranolol hydrochloride, USP. Propranolol Hydrochloride Tablets, USP also contain lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Color additives include FD&C Yellow No. 6 aluminum lake (10 mg and 80 mg), D&C Yellow No. 10 aluminum lake (10 mg, 40 mg, and 80 mg), FD&C Blue No. 1 aluminum lake (20 mg and 40 mg) and FD&C Red No. 40 aluminum lake (60 mg).</Description>
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<PackageDescription>100 TABLET in 1 BOTTLE (69238-2078-1) </PackageDescription>
<NDC11Code>69238-2078-01</NDC11Code>
<ProductNDC>69238-2078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071972</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
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<LastUpdate>2026-07-06</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypertension. Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride is not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis. Propranolol hydrochloride tablets are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation. Propranolol hydrochloride tablets are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response. Myocardial Infarction. Propranolol is indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Migraine. Propranolol is indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Essential Tremor. Propranolol is indicated in the management of familial or hereditary essential tremor. Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest, but occurs when the limb is held in a fixed posture or position against gravity and during active movement. Propranolol causes a reduction in the tremor amplitude, but not in the tremor frequency. Propranolol is not indicated for the treatment of tremor associated with Parkinsonism. Hypertrophic Subaortic Stenosis. Propranolol improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis. Pheochromocytoma. Propranolol is indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.</IndicationAndUsage>
<Description>Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-. Its structural formula is. Propranolol hydrochloride, USP is a stable, white to off-white, crystalline powder which is readily soluble in water and ethanol. Propranolol Hydrochloride Tablets, USP are available as tablets for oral administration containing either 10 mg, 20 mg, 40 mg, 60 mg, or 80 mg of propranolol hydrochloride, USP. Propranolol Hydrochloride Tablets, USP also contain lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. Color additives include FD&C Yellow No. 6 aluminum lake (10 mg and 80 mg), D&C Yellow No. 10 aluminum lake (10 mg, 40 mg, and 80 mg), FD&C Blue No. 1 aluminum lake (20 mg and 40 mg) and FD&C Red No. 40 aluminum lake (60 mg).</Description>
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<NDCCode>58228-2078-1</NDCCode>
<PackageDescription>1000 BOX in 1 CASE (58228-2078-1) / 10 POUCH in 1 BOX / .55 mL in 1 POUCH</PackageDescription>
<NDC11Code>58228-2078-01</NDC11Code>
<ProductNDC>58228-2078</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alcohol Wipes</ProprietaryName>
<NonProprietaryName>Alcohol Wipes</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240108</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>ProStat First Aid LLC</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> First aid to help prevent infection in minor cuts, scrapes, and burns. For preparation of the skin prior to an injection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70710-2078-2</NDCCode>
<PackageDescription>2 SYRINGE, PLASTIC in 1 PACKAGE (70710-2078-2) / .5 mL in 1 SYRINGE, PLASTIC</PackageDescription>
<NDC11Code>70710-2078-02</NDC11Code>
<ProductNDC>70710-2078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diazepam</ProprietaryName>
<NonProprietaryName>Diazepam</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20251215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217468</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DIAZEPAM</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diazepam rectal gel is intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 2 years of age and older.</IndicationAndUsage>
<Description>Diazepam rectal gel rectal delivery system is a non-sterile diazepam gel provided in a prefilled, unit-dose, rectal delivery system. Diazepam rectal gel contains 5 mg/mL diazepam, benzoic acid, benzyl alcohol (1.5%), ethyl alcohol (10%), hydroxypropyl methylcellulose, propylene glycol, purified water, and sodium benzoate. Diazepam rectal gel is clear, colorless to yellow and has a pH between 6.5-7.2. Diazepam, the active ingredient of diazepam rectal gel, is a benzodiazepine anticonvulsant with the chemical name 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. The structural formula is as follows.</Description>
</NDC>
<NDC>
<NDCCode>71335-2078-1</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2078-1) </PackageDescription>
<NDC11Code>71335-2078-01</NDC11Code>
<ProductNDC>71335-2078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205868</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lansoprazole delayed-release capsules are proton pump inhibitors (PPIs) indicated for the: : 1 Treatment of active duodenal ulcer in adults( 1.1) , 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults ( 1.2) , 3 Maintenance of healed duodenal ulcers in adults ( 1.3) , 4 Treatment of active benign gastric ulcer in adults ( 1.4) , 5 Healing of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults ( 1.5) , 6 Risk reduction of NSAID-associated gastric ulcer in adults( 1.6) , 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older ( 1.7) , 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older ( 1.8) , 9 Maintenance of healing of EE in adults.( 1.9) , 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults ( 1.10) .</IndicationAndUsage>
<Description>The active ingredient in Lansoprazole Delayed-Release 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 C 16H 14F 3N 3O 2S with a molecular weight of 369.37. Lansoprazole has the following structure:. Lansoprazole USP is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and 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 is supplied in delayed-release capsules, USP for oral administration. Lansoprazole delayed-release capsules,USP are available in two dosage strengths: 15 mg and 30 mg of lansoprazole USP per capsule. Each delayed-release capsule contains enteric-coated pellets consisting of 15 mg or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: corn starch, gelatin, hydroxypropyl cellulose, magnesium carbonate, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, sucrose, sugar spheres, talc, titanium dioxide, FD&C Blue 2 1, Iron oxide yellow 1, Iron oxide black 2. 1 Lansoprazole delayed-release capsules, USP 15 mg only. 2 Lansoprazole delayed-release capsules, USP 30 mg only.</Description>
</NDC>
<NDC>
<NDCCode>71335-2078-2</NDCCode>
<PackageDescription>15 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2078-2) </PackageDescription>
<NDC11Code>71335-2078-02</NDC11Code>
<ProductNDC>71335-2078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205868</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lansoprazole delayed-release capsules are proton pump inhibitors (PPIs) indicated for the: : 1 Treatment of active duodenal ulcer in adults( 1.1) , 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults ( 1.2) , 3 Maintenance of healed duodenal ulcers in adults ( 1.3) , 4 Treatment of active benign gastric ulcer in adults ( 1.4) , 5 Healing of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults ( 1.5) , 6 Risk reduction of NSAID-associated gastric ulcer in adults( 1.6) , 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older ( 1.7) , 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older ( 1.8) , 9 Maintenance of healing of EE in adults.( 1.9) , 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults ( 1.10) .</IndicationAndUsage>
<Description>The active ingredient in Lansoprazole Delayed-Release 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 C 16H 14F 3N 3O 2S with a molecular weight of 369.37. Lansoprazole has the following structure:. Lansoprazole USP is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and 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 is supplied in delayed-release capsules, USP for oral administration. Lansoprazole delayed-release capsules,USP are available in two dosage strengths: 15 mg and 30 mg of lansoprazole USP per capsule. Each delayed-release capsule contains enteric-coated pellets consisting of 15 mg or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: corn starch, gelatin, hydroxypropyl cellulose, magnesium carbonate, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, sucrose, sugar spheres, talc, titanium dioxide, FD&C Blue 2 1, Iron oxide yellow 1, Iron oxide black 2. 1 Lansoprazole delayed-release capsules, USP 15 mg only. 2 Lansoprazole delayed-release capsules, USP 30 mg only.</Description>
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<NDCCode>71335-2078-3</NDCCode>
<PackageDescription>60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2078-3) </PackageDescription>
<NDC11Code>71335-2078-03</NDC11Code>
<ProductNDC>71335-2078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205868</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lansoprazole delayed-release capsules are proton pump inhibitors (PPIs) indicated for the: : 1 Treatment of active duodenal ulcer in adults( 1.1) , 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults ( 1.2) , 3 Maintenance of healed duodenal ulcers in adults ( 1.3) , 4 Treatment of active benign gastric ulcer in adults ( 1.4) , 5 Healing of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults ( 1.5) , 6 Risk reduction of NSAID-associated gastric ulcer in adults( 1.6) , 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older ( 1.7) , 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older ( 1.8) , 9 Maintenance of healing of EE in adults.( 1.9) , 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults ( 1.10) .</IndicationAndUsage>
<Description>The active ingredient in Lansoprazole Delayed-Release 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 C 16H 14F 3N 3O 2S with a molecular weight of 369.37. Lansoprazole has the following structure:. Lansoprazole USP is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and 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 is supplied in delayed-release capsules, USP for oral administration. Lansoprazole delayed-release capsules,USP are available in two dosage strengths: 15 mg and 30 mg of lansoprazole USP per capsule. Each delayed-release capsule contains enteric-coated pellets consisting of 15 mg or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: corn starch, gelatin, hydroxypropyl cellulose, magnesium carbonate, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, sucrose, sugar spheres, talc, titanium dioxide, FD&C Blue 2 1, Iron oxide yellow 1, Iron oxide black 2. 1 Lansoprazole delayed-release capsules, USP 15 mg only. 2 Lansoprazole delayed-release capsules, USP 30 mg only.</Description>
</NDC>
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<NDCCode>71335-2078-4</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2078-4) </PackageDescription>
<NDC11Code>71335-2078-04</NDC11Code>
<ProductNDC>71335-2078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205868</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lansoprazole delayed-release capsules are proton pump inhibitors (PPIs) indicated for the: : 1 Treatment of active duodenal ulcer in adults( 1.1) , 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults ( 1.2) , 3 Maintenance of healed duodenal ulcers in adults ( 1.3) , 4 Treatment of active benign gastric ulcer in adults ( 1.4) , 5 Healing of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults ( 1.5) , 6 Risk reduction of NSAID-associated gastric ulcer in adults( 1.6) , 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older ( 1.7) , 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older ( 1.8) , 9 Maintenance of healing of EE in adults.( 1.9) , 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults ( 1.10) .</IndicationAndUsage>
<Description>The active ingredient in Lansoprazole Delayed-Release 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 C 16H 14F 3N 3O 2S with a molecular weight of 369.37. Lansoprazole has the following structure:. Lansoprazole USP is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and 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 is supplied in delayed-release capsules, USP for oral administration. Lansoprazole delayed-release capsules,USP are available in two dosage strengths: 15 mg and 30 mg of lansoprazole USP per capsule. Each delayed-release capsule contains enteric-coated pellets consisting of 15 mg or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: corn starch, gelatin, hydroxypropyl cellulose, magnesium carbonate, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, sucrose, sugar spheres, talc, titanium dioxide, FD&C Blue 2 1, Iron oxide yellow 1, Iron oxide black 2. 1 Lansoprazole delayed-release capsules, USP 15 mg only. 2 Lansoprazole delayed-release capsules, USP 30 mg only.</Description>
</NDC>
<NDC>
<NDCCode>71335-2078-5</NDCCode>
<PackageDescription>28 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2078-5) </PackageDescription>
<NDC11Code>71335-2078-05</NDC11Code>
<ProductNDC>71335-2078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205868</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lansoprazole delayed-release capsules are proton pump inhibitors (PPIs) indicated for the: : 1 Treatment of active duodenal ulcer in adults( 1.1) , 2 Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults ( 1.2) , 3 Maintenance of healed duodenal ulcers in adults ( 1.3) , 4 Treatment of active benign gastric ulcer in adults ( 1.4) , 5 Healing of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults ( 1.5) , 6 Risk reduction of NSAID-associated gastric ulcer in adults( 1.6) , 7 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older ( 1.7) , 8 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older ( 1.8) , 9 Maintenance of healing of EE in adults.( 1.9) , 10 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults ( 1.10) .</IndicationAndUsage>
<Description>The active ingredient in Lansoprazole Delayed-Release 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 C 16H 14F 3N 3O 2S with a molecular weight of 369.37. Lansoprazole has the following structure:. Lansoprazole USP is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and 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 is supplied in delayed-release capsules, USP for oral administration. Lansoprazole delayed-release capsules,USP are available in two dosage strengths: 15 mg and 30 mg of lansoprazole USP per capsule. Each delayed-release capsule contains enteric-coated pellets consisting of 15 mg or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: corn starch, gelatin, hydroxypropyl cellulose, magnesium carbonate, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, sucrose, sugar spheres, talc, titanium dioxide, FD&C Blue 2 1, Iron oxide yellow 1, Iron oxide black 2. 1 Lansoprazole delayed-release capsules, USP 15 mg only. 2 Lansoprazole delayed-release capsules, USP 30 mg only.</Description>
</NDC>
<NDC>
<NDCCode>69238-1031-7</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (69238-1031-7) / 1 KIT in 1 BLISTER PACK (69238-1031-6) </PackageDescription>
<NDC11Code>69238-1031-07</NDC11Code>
<ProductNDC>69238-1031</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Melodetta 24 Fe</ProprietaryName>
<NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20170921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207514</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-07-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Melodetta 24 Fe is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)]. The efficacy of Melodetta 24 Fe in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.</IndicationAndUsage>
<Description>Melodetta 24 Fe provides an oral contraceptive regimen consisting of 24 white active chewable tablets that contain the active ingredients, followed by 4 brown non-hormonal placebo tablets as specified below: : 1 24 white, round tablets each containing 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP. , 2 4 brown, round tablets each containing 75 mg ferrous fumarate. .</Description>
</NDC>
<NDC>
<NDCCode>69238-1065-7</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (69238-1065-7) </PackageDescription>
<NDC11Code>69238-1065-07</NDC11Code>
<ProductNDC>69238-1065</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200511</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212861</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200511</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. : 1 For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia., 2 For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias. .</IndicationAndUsage>
<Description>The Potassium Chloride Extended-Release Tablets USP, 20 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. The Potassium Chloride Extended-Release Tablets USP, 15 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,125 mg of microencapsulated potassium chloride, USP equivalent to 15 mEq of potassium in a tablet. The Potassium Chloride Extended-Release Tablets USP, 10 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium Chloride is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Its molecular weight is 74.55 g/mole. Potassium chloride, USP occurs as a white to off-white, crystalline, granular powder. It is freely soluble in water and insoluble in alcohol. Potassium Chloride is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of out-side agitation, potassium chloride tablets begin disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride. Inactive Ingredients: croscarmellose sodium, ethyl cellulose, microcrystalline cellulose and triethyl citrate. Meets USP Dissolution Test 7.</Description>
</NDC>
<NDC>
<NDCCode>69238-1165-7</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (69238-1165-7) </PackageDescription>
<NDC11Code>69238-1165-07</NDC11Code>
<ProductNDC>69238-1165</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abiraterone Acetate</ProprietaryName>
<NonProprietaryName>Abiraterone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208327</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>ABIRATERONE ACETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with : 1 Metastatic castration-resistant prostate cancer (CRPC), 2 Metastatic high-risk castration-sensitive prostate cancer (CSPC).</IndicationAndUsage>
<Description>Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is. Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C26H33NO2 and it has a molecular weight of 391.55. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg uncoated tablets and 500 mg film-coated tablets with the following inactive ingredients: : 1 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate., 2 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating, Opadry® II Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. .</Description>
</NDC>
<NDC>
<NDCCode>69238-1293-7</NDCCode>
<PackageDescription>8 POUCH in 1 CARTON (69238-1293-7) / 1 d in 1 POUCH (69238-1293-1) </PackageDescription>
<NDC11Code>69238-1293-07</NDC11Code>
<ProductNDC>69238-1293</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20200930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211396</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.0375</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system is indicated for.</IndicationAndUsage>
<Description>Estradiol transdermal system USP, contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system, USP are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol, USP is C18H2402. The molecular weight is 272.39. Estradiol transdermal system USP, is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. Meets USP Drug Release Test 6.</Description>
</NDC>
<NDC>
<NDCCode>69238-1294-7</NDCCode>
<PackageDescription>8 POUCH in 1 CARTON (69238-1294-7) / 1 d in 1 POUCH (69238-1294-1) </PackageDescription>
<NDC11Code>69238-1294-07</NDC11Code>
<ProductNDC>69238-1294</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20200930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211396</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.075</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system is indicated for.</IndicationAndUsage>
<Description>Estradiol transdermal system USP, contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system, USP are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol, USP is C18H2402. The molecular weight is 272.39. Estradiol transdermal system USP, is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. Meets USP Drug Release Test 6.</Description>
</NDC>
<NDC>
<NDCCode>69238-1295-7</NDCCode>
<PackageDescription>8 POUCH in 1 CARTON (69238-1295-7) / 1 d in 1 POUCH (69238-1295-1) </PackageDescription>
<NDC11Code>69238-1295-07</NDC11Code>
<ProductNDC>69238-1295</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20200930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211396</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system is indicated for.</IndicationAndUsage>
<Description>Estradiol transdermal system USP, contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system, USP are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol, USP is C18H2402. The molecular weight is 272.39. Estradiol transdermal system USP, is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. Meets USP Drug Release Test 6.</Description>
</NDC>
<NDC>
<NDCCode>69238-1296-7</NDCCode>
<PackageDescription>8 POUCH in 1 CARTON (69238-1296-7) / 1 d in 1 POUCH (69238-1296-1) </PackageDescription>
<NDC11Code>69238-1296-07</NDC11Code>
<ProductNDC>69238-1296</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20200930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211396</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system is indicated for.</IndicationAndUsage>
<Description>Estradiol transdermal system USP, contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system, USP are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol, USP is C18H2402. The molecular weight is 272.39. Estradiol transdermal system USP, is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. Meets USP Drug Release Test 6.</Description>
</NDC>
<NDC>
<NDCCode>69238-1308-7</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (69238-1308-7) / 10 TABLET, FILM COATED in 1 BLISTER PACK (69238-1308-1) </PackageDescription>
<NDC11Code>69238-1308-07</NDC11Code>
<ProductNDC>69238-1308</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solifenacin Succinate</ProprietaryName>
<NonProprietaryName>Solifenacin Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209719</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>SOLIFENACIN SUCCINATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
<Description>Solifenacin succinate is a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)-iso-quinolinecarboxylate (1:1) having a molecular formula of C23H26N2O2C4H6O4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each solifenacin succinate tablet contains 5 mg or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inactive ingredients: butylated hydroxyanisole, corn starch, hypromellose, iron oxide yellow (5 mg), iron oxide red (10 mg), lactose monohydrate, magnesium stearate, polyethylene glycol, propyl gallate, titanium dioxide, talc and tartaric acid.</Description>
</NDC>
<NDC>
<NDCCode>69238-1309-7</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (69238-1309-7) / 10 TABLET, FILM COATED in 1 BLISTER PACK (69238-1309-1) </PackageDescription>
<NDC11Code>69238-1309-07</NDC11Code>
<ProductNDC>69238-1309</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solifenacin Succinate</ProprietaryName>
<NonProprietaryName>Solifenacin Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209719</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>SOLIFENACIN SUCCINATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.</IndicationAndUsage>
<Description>Solifenacin succinate is a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)-iso-quinolinecarboxylate (1:1) having a molecular formula of C23H26N2O2C4H6O4, and a molecular weight of 480.55. The structural formula of solifenacin succinate is. Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder. It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. Each solifenacin succinate tablet contains 5 mg or 10 mg of solifenacin succinate and is for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inactive ingredients: butylated hydroxyanisole, corn starch, hypromellose, iron oxide yellow (5 mg), iron oxide red (10 mg), lactose monohydrate, magnesium stearate, polyethylene glycol, propyl gallate, titanium dioxide, talc and tartaric acid.</Description>
</NDC>
<NDC>
<NDCCode>69238-1447-7</NDCCode>
<PackageDescription>8 POUCH in 1 CARTON (69238-1447-7) / 1 d in 1 POUCH (69238-1447-1) </PackageDescription>
<NDC11Code>69238-1447-07</NDC11Code>
<ProductNDC>69238-1447</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20200930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211396</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.025</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system is indicated for.</IndicationAndUsage>
<Description>Estradiol transdermal system USP, contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system, USP are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol, USP is C18H2402. The molecular weight is 272.39. Estradiol transdermal system USP, is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. Meets USP Drug Release Test 6.</Description>
</NDC>
<NDC>
<NDCCode>69238-1521-3</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (69238-1521-3) / 1 PATCH in 1 POUCH (69238-1521-1) / 7 d in 1 PATCH</PackageDescription>
<NDC11Code>69238-1521-03</NDC11Code>
<ProductNDC>69238-1521</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Norelgestromin And Ethinly Estradiol</ProprietaryName>
<NonProprietaryName>Norelgestromin And Ethinly Estradiol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20210226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213950</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>NORELGESTROMIN; ETHINYL ESTRADIOL</SubstanceName>
<StrengthNumber>150; 35</StrengthNumber>
<StrengthUnit>ug/d; ug/d</StrengthUnit>
<Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Norelgestromin and ethinyl estradiol transdermal system is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate. Limitations of Use:. Norelgestromin and ethinyl estradiol transdermal system may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more. Norelgestromin and ethinyl estradiol transdermal system is contraindicated for use in women with BMI ≥ 30 kg/m2 [see Contraindications (4), Warnings and Precautions (5.1) and Clinical Studies (14)].</IndicationAndUsage>
<Description>Norelgestromin and ethinyl estradiol transdermal system has a contact surface area of 12.5 cm2. It contains 3.15 mg norelgestromin, USP (NGMN) and 0.289 mg ethinyl estradiol, USP (EE), and its delivery rate is approximately 150 mcg of NGMN, USP and 35 mcg of EE, USP per day. Systemic exposures (as measured by area under the curve [AUC] and steady-state concentration [Css]) of NGMN, USP and EE, USP during use of norelgestromin and ethinyl estradiol transdermal system are higher and the Cmax is lower than those produced by an oral contraceptive containing norgestimate, USP (NGM) 250 mcg / EE, USP 35 mcg [see Boxed Warning and Clinical Pharmacology (12.3)]. Norelgestromin and ethinyl estradiol transdermal system is a thin, matrix-type transdermal system consisting of three layers. The backing layer is composed of a tan backing consisting of pigmented polyethylene and polyester. It provides structural support and protects the middle adhesive layer from the environment. The middle layer contains polyisobutylene/polybutene adhesive, polybutene, crospovidone, oleyl alcohol and dipropylene glycol as inactive components. The active components in this layer are the hormones, NGMN, USP and EE, USP. The third layer is the release liner, which protects the adhesive layer during storage and is removed just prior to application. It is a transparent polyethylene terephthalate (PET) film with a silicone coating on the side that is in contact with the middle adhesive layer. The outside of the backing layer is printed with “Norelgestromin and Ethinyl Estradiol 150/35 mcg per day” in brown ink. The structural formulas of the components are. Norelgestromin, USP ethinyl estradiol, USP. Molecular weight, NGMN, USP: 327.47. Molecular weight, EE, USP: 296.41. Chemical name for NGMN, USP: 18, 19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-,3-oxime,(17α). Chemical name for EE, USP: 19-Norpregna-1,3,5(10)-trien-20-yne-3, 17-diol,(17α).</Description>
</NDC>
<NDC>
<NDCCode>69238-1524-7</NDCCode>
<PackageDescription>8 APPLICATOR in 1 CARTON (69238-1524-7) > 1 TABLET in 1 APPLICATOR</PackageDescription>
<NDC11Code>69238-1524-07</NDC11Code>
<ProductNDC>69238-1524</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Yuvafem</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20160201</StartMarketingDate>
<EndMarketingDate>20200401</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020908</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>ESTRADIOL HEMIHYDRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160201</StartMarketingDatePackage>
<EndMarketingDatePackage>20200401</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69238-1629-7</NDCCode>
<PackageDescription>8 POUCH in 1 CARTON (69238-1629-7) / 1 d in 1 POUCH (69238-1629-1) </PackageDescription>
<NDC11Code>69238-1629-07</NDC11Code>
<ProductNDC>69238-1629</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20190204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211293</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.025</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system is indicated for.</IndicationAndUsage>
<Description>Estradiol transdermal system, USP contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system, USP are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)- triene-3,17β-diol. The structural formula is. The molecular formula of estradiol, USP is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system, USP is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. FDA approved acceptance criteria for dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>69238-1630-7</NDCCode>
<PackageDescription>8 POUCH in 1 CARTON (69238-1630-7) / 1 d in 1 POUCH (69238-1630-1) </PackageDescription>
<NDC11Code>69238-1630-07</NDC11Code>
<ProductNDC>69238-1630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20190204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211293</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.0375</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system is indicated for.</IndicationAndUsage>
<Description>Estradiol transdermal system, USP contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system, USP are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)- triene-3,17β-diol. The structural formula is. The molecular formula of estradiol, USP is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system, USP is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. FDA approved acceptance criteria for dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>69238-1631-7</NDCCode>
<PackageDescription>8 POUCH in 1 CARTON (69238-1631-7) / 1 d in 1 POUCH (69238-1631-1) </PackageDescription>
<NDC11Code>69238-1631-07</NDC11Code>
<ProductNDC>69238-1631</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20190204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211293</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system is indicated for.</IndicationAndUsage>
<Description>Estradiol transdermal system, USP contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system, USP are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)- triene-3,17β-diol. The structural formula is. The molecular formula of estradiol, USP is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system, USP is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. FDA approved acceptance criteria for dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>69238-1632-7</NDCCode>
<PackageDescription>8 POUCH in 1 CARTON (69238-1632-7) / 1 d in 1 POUCH (69238-1632-1) </PackageDescription>
<NDC11Code>69238-1632-07</NDC11Code>
<ProductNDC>69238-1632</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20190204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211293</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.075</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system is indicated for.</IndicationAndUsage>
<Description>Estradiol transdermal system, USP contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system, USP are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)- triene-3,17β-diol. The structural formula is. The molecular formula of estradiol, USP is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system, USP is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. FDA approved acceptance criteria for dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>69238-1633-7</NDCCode>
<PackageDescription>8 POUCH in 1 CARTON (69238-1633-7) / 1 d in 1 POUCH (69238-1633-1) </PackageDescription>
<NDC11Code>69238-1633-07</NDC11Code>
<ProductNDC>69238-1633</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20190204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211293</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system is indicated for.</IndicationAndUsage>
<Description>Estradiol transdermal system, USP contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system, USP are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol, USP per day via the skin. Each corresponding system has an active surface area of 1.89, 2.83, 3.78, 5.66, or 7.55 cm2 and contains 0.314, 0.470, 0.627, 0.940, or 1.253 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol, USP is a white to practically white powder, chemically described as estra-1,3,5 (10)- triene-3,17β-diol. The structural formula is. The molecular formula of estradiol, USP is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system, USP is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) polyester and ethylene vinyl acetate copolymer film (2) an adhesive formulation containing estradiol USP, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol, USP. The remaining components of the system are pharmacologically inactive. FDA approved acceptance criteria for dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>69238-1642-7</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (69238-1642-7) / 270 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>69238-1642-07</NDC11Code>
<ProductNDC>69238-1642</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pirfenidone</ProprietaryName>
<NonProprietaryName>Pirfenidone</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220107</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212569</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>PIRFENIDONE</SubstanceName>
<StrengthNumber>267</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Pyridone [EPC], Pyridones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pirfenidone capsules are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).</IndicationAndUsage>
<Description>Pirfenidone, USP belongs to the chemical class of pyridone. Pirfenidone capsules, USP are available as a opaque white to off-white hard gelatin capsule containing 267 mg of pirfenidone, USP for oral administration. Pirfenidone, USP has a molecular formula of C12H11NO and a molecular weight of 185.22 g/mol. Pirfenidone, USP has the following structural formula, which has been referred to as 5-methyl-1-phenylpyridin-2-one. Pirfenidone, USP is a white to pale yellow, non-hygroscopic, crystalline powder. It is sparingly soluble in water, freely soluble in ethanol (96%), and slightly soluble in heptane. The melting point range is 107°C to 111°C. Each pirfenidone capsule, USP contains pirfenidone USP, 267 mg as active ingredient and the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, and magnesium stearate. In addition, the capsule shell contains gelatin and titanium dioxide. The capsule is imprinted with black pharmaceutical ink which includes butyl alcohol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>69238-1720-7</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE, PLASTIC (69238-1720-7) </PackageDescription>
<NDC11Code>69238-1720-07</NDC11Code>
<ProductNDC>69238-1720</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etravirine</ProprietaryName>
<NonProprietaryName>Etravirine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214196</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>ETRAVIRINE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69238-1721-7</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE, PLASTIC (69238-1721-7) </PackageDescription>
<NDC11Code>69238-1721-07</NDC11Code>
<ProductNDC>69238-1721</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etravirine</ProprietaryName>
<NonProprietaryName>Etravirine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214196</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>ETRAVIRINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69238-1729-7</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (69238-1729-7) / 150 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>69238-1729-07</NDC11Code>
<ProductNDC>69238-1729</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enalapril Maleate</ProprietaryName>
<NonProprietaryName>Enalapril</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212894</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>ENALAPRIL MALEATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Enalapril maleate oral solution is an angiotensin-converting enzyme inhibitor indicated for: : 1 treatment of hypertension in adults and children older than one month, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) , 2 treatment of symptomatic heart failure. (1.2) , 3 treatment of asymptomatic left ventricular dysfunction, to decrease the rate of development of overt heart failure and reduce hospitalization for heart failure. (1.3) .</IndicationAndUsage>
<Description>Enalapril maleate (enalapril maleate) oral solution is the maleate salt of enalapril, the ethyl ester prodrug of a long-acting angiotensin-converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C20H28N2O5C4H4O4, and its structural formula is. Enalapril maleate is an off-white, crystalline powder with a molecular weight of 492.52. It is sparingly soluble in water, soluble in ethanol, and freely soluble in methanol. Enalapril maleate oral solution is a ready-to-use oral solution. Each 1 mL contains 1 mg of enalapril maleate, USP equivalent to 0.764 mg of enalapril. Inactive ingredients include artificial juicy raspberry flavor, malic acid, purified water, sodium benzoate, and sucralose. Enalapril maleate oral solution is clear and colorless.</Description>
</NDC>
</NDCList>