{
"NDC": [
{
"NDCCode": "0054-4858-51",
"PackageDescription": "10 TABLET in 1 BOTTLE (0054-4858-51)",
"NDC11Code": "00054-4858-51",
"ProductNDC": "0054-4858",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triazolam",
"NonProprietaryName": "Triazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090713",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074224",
"LabelerName": "Roxane Laboratories, Inc.",
"SubstanceName": "TRIAZOLAM",
"StrengthNumber": ".125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2015-01-16"
},
{
"NDCCode": "0054-4858-25",
"PackageDescription": "100 TABLET in 1 BOTTLE (0054-4858-25) ",
"NDC11Code": "00054-4858-25",
"ProductNDC": "0054-4858",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triazolam",
"NonProprietaryName": "Triazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181029",
"EndMarketingDate": "20241031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074224",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "TRIAZOLAM",
"StrengthNumber": ".125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181029",
"EndMarketingDatePackage": "20241031",
"SamplePackage": "N",
"IndicationAndUsage": "Triazolam is indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults.",
"Description": "Triazolam Tablets, USP contain triazolam, a triazolobenzodiazepine. Triazolam, USP is a white to off-white powder, soluble in chloroform; slightly soluble in alcohol; and practically insoluble in ether and in water. It has a molecular weight of 343.2. The chemical name for triazolam is 8-chloro-6-(o-chlorophenyl)-1-methyl-4H-s-triazolo-[4,3-α][1,4]benzodiazepine. The structural formula is represented below: 1 ."
},
{
"NDCCode": "0054-0379-51",
"PackageDescription": "60 mL in 1 BOTTLE, UNIT-DOSE (0054-0379-51) ",
"NDC11Code": "00054-0379-51",
"ProductNDC": "0054-0379",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Polystyrene Sulfonate",
"NonProprietaryName": "Sodium Polystyrene Sulfonate",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL; RECTAL",
"StartMarketingDate": "20130617",
"EndMarketingDate": "20210131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089049",
"LabelerName": "West-Ward Pharmaceuticals Corp.",
"SubstanceName": "SODIUM POLYSTYRENE SULFONATE",
"StrengthNumber": "15",
"StrengthUnit": "g/60mL",
"Status": "Deprecated",
"LastUpdate": "2021-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130617",
"EndMarketingDatePackage": "20210131",
"SamplePackage": "N"
},
{
"NDCCode": "70257-054-51",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (70257-054-51) / 5 mL in 1 VIAL, GLASS (70257-054-05) ",
"NDC11Code": "70257-0054-51",
"ProductNDC": "70257-054",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hepagam B",
"NonProprietaryName": "Human Hepatitis B Virus Immune Globulin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20180620",
"EndMarketingDate": "20240430",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125035",
"LabelerName": "Saol Therapeutics Inc.",
"SubstanceName": "HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN",
"StrengthNumber": "312",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Human Immunoglobulin [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT]",
"Status": "Deprecated",
"LastUpdate": "2024-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180620",
"EndMarketingDatePackage": "20240430",
"SamplePackage": "N"
},
{
"NDCCode": "0054-0106-25",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0054-0106-25) ",
"NDC11Code": "00054-0106-25",
"ProductNDC": "0054-0106",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramipril",
"NonProprietaryName": "Ramipril",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20080618",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077900",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "RAMIPRIL",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080618",
"SamplePackage": "N",
"IndicationAndUsage": "Ramipril is an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics (1.1).In patients 55 years or older at high risk of developing a major cardiovascular event, ramipril is indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes (1.2).Ramipril is indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction (1.3).",
"Description": "Ramipril, USP is a 2‑aza‑bicyclo [3.3.0]‑octane‑3‑carboxylic acid derivative. It is a white to almost white, crystalline powder freely soluble in methanol. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2S,3aS,6aS)‑1-[(S)‑N‑[(S)‑1-Carboxy‑3‑phenylpropyl]alanyl]octahydrocyclopenta[b]pyrrole‑2‑carboxylic acid, 1‑ethyl ester. Ramipril Capsules, USP are available for oral administration containing either 1.25 mg, 2.5 mg, 5 mg or 10 mg ramipril, USP and the following inactive ingredient: pregelatinized starch. Each capsule shell contains black monogramming ink, gelatin and titanium dioxide. The black monogramming ink contains: black iron oxide, FD&C blue #2, FD&C red #40, FD&C yellow #6, propylene glycol and shellac glaze. The 1.25 mg capsule shell contains D&C yellow #10 and FD&C yellow #6. The 2.5 mg capsule shell contains FD&C yellow #6. The 5 mg capsule shell contains D&C red #28, FD&C blue #1 and FD&C yellow #6. The 10 mg capsule shell contains D&C red #28 and FD&C blue #1. The structural formula for ramipril is. Its molecular formula is C23H32N2O5, and its molecular weight is 416.51. Ramiprilat, the diacid metabolite of ramipril, is a non‑sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group."
},
{
"NDCCode": "0054-0107-20",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (0054-0107-20) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "00054-0107-20",
"ProductNDC": "0054-0107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramipril",
"NonProprietaryName": "Ramipril",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20080618",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077900",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "RAMIPRIL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080618",
"SamplePackage": "N",
"IndicationAndUsage": "Ramipril is an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics (1.1).In patients 55 years or older at high risk of developing a major cardiovascular event, ramipril is indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes (1.2).Ramipril is indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction (1.3).",
"Description": "Ramipril, USP is a 2‑aza‑bicyclo [3.3.0]‑octane‑3‑carboxylic acid derivative. It is a white to almost white, crystalline powder freely soluble in methanol. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2S,3aS,6aS)‑1-[(S)‑N‑[(S)‑1-Carboxy‑3‑phenylpropyl]alanyl]octahydrocyclopenta[b]pyrrole‑2‑carboxylic acid, 1‑ethyl ester. Ramipril Capsules, USP are available for oral administration containing either 1.25 mg, 2.5 mg, 5 mg or 10 mg ramipril, USP and the following inactive ingredient: pregelatinized starch. Each capsule shell contains black monogramming ink, gelatin and titanium dioxide. The black monogramming ink contains: black iron oxide, FD&C blue #2, FD&C red #40, FD&C yellow #6, propylene glycol and shellac glaze. The 1.25 mg capsule shell contains D&C yellow #10 and FD&C yellow #6. The 2.5 mg capsule shell contains FD&C yellow #6. The 5 mg capsule shell contains D&C red #28, FD&C blue #1 and FD&C yellow #6. The 10 mg capsule shell contains D&C red #28 and FD&C blue #1. The structural formula for ramipril is. Its molecular formula is C23H32N2O5, and its molecular weight is 416.51. Ramiprilat, the diacid metabolite of ramipril, is a non‑sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group."
},
{
"NDCCode": "0054-0107-25",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0054-0107-25) ",
"NDC11Code": "00054-0107-25",
"ProductNDC": "0054-0107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramipril",
"NonProprietaryName": "Ramipril",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20080618",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077900",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "RAMIPRIL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080618",
"SamplePackage": "N",
"IndicationAndUsage": "Ramipril is an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics (1.1).In patients 55 years or older at high risk of developing a major cardiovascular event, ramipril is indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes (1.2).Ramipril is indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction (1.3).",
"Description": "Ramipril, USP is a 2‑aza‑bicyclo [3.3.0]‑octane‑3‑carboxylic acid derivative. It is a white to almost white, crystalline powder freely soluble in methanol. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2S,3aS,6aS)‑1-[(S)‑N‑[(S)‑1-Carboxy‑3‑phenylpropyl]alanyl]octahydrocyclopenta[b]pyrrole‑2‑carboxylic acid, 1‑ethyl ester. Ramipril Capsules, USP are available for oral administration containing either 1.25 mg, 2.5 mg, 5 mg or 10 mg ramipril, USP and the following inactive ingredient: pregelatinized starch. Each capsule shell contains black monogramming ink, gelatin and titanium dioxide. The black monogramming ink contains: black iron oxide, FD&C blue #2, FD&C red #40, FD&C yellow #6, propylene glycol and shellac glaze. The 1.25 mg capsule shell contains D&C yellow #10 and FD&C yellow #6. The 2.5 mg capsule shell contains FD&C yellow #6. The 5 mg capsule shell contains D&C red #28, FD&C blue #1 and FD&C yellow #6. The 10 mg capsule shell contains D&C red #28 and FD&C blue #1. The structural formula for ramipril is. Its molecular formula is C23H32N2O5, and its molecular weight is 416.51. Ramiprilat, the diacid metabolite of ramipril, is a non‑sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group."
},
{
"NDCCode": "0054-0107-29",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (0054-0107-29) ",
"NDC11Code": "00054-0107-29",
"ProductNDC": "0054-0107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramipril",
"NonProprietaryName": "Ramipril",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20080618",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077900",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "RAMIPRIL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080618",
"SamplePackage": "N",
"IndicationAndUsage": "Ramipril is an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics (1.1).In patients 55 years or older at high risk of developing a major cardiovascular event, ramipril is indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes (1.2).Ramipril is indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction (1.3).",
"Description": "Ramipril, USP is a 2‑aza‑bicyclo [3.3.0]‑octane‑3‑carboxylic acid derivative. It is a white to almost white, crystalline powder freely soluble in methanol. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2S,3aS,6aS)‑1-[(S)‑N‑[(S)‑1-Carboxy‑3‑phenylpropyl]alanyl]octahydrocyclopenta[b]pyrrole‑2‑carboxylic acid, 1‑ethyl ester. Ramipril Capsules, USP are available for oral administration containing either 1.25 mg, 2.5 mg, 5 mg or 10 mg ramipril, USP and the following inactive ingredient: pregelatinized starch. Each capsule shell contains black monogramming ink, gelatin and titanium dioxide. The black monogramming ink contains: black iron oxide, FD&C blue #2, FD&C red #40, FD&C yellow #6, propylene glycol and shellac glaze. The 1.25 mg capsule shell contains D&C yellow #10 and FD&C yellow #6. The 2.5 mg capsule shell contains FD&C yellow #6. The 5 mg capsule shell contains D&C red #28, FD&C blue #1 and FD&C yellow #6. The 10 mg capsule shell contains D&C red #28 and FD&C blue #1. The structural formula for ramipril is. Its molecular formula is C23H32N2O5, and its molecular weight is 416.51. Ramiprilat, the diacid metabolite of ramipril, is a non‑sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group."
},
{
"NDCCode": "0054-0108-20",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (0054-0108-20) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "00054-0108-20",
"ProductNDC": "0054-0108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramipril",
"NonProprietaryName": "Ramipril",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20080618",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077900",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "RAMIPRIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080618",
"SamplePackage": "N",
"IndicationAndUsage": "Ramipril is an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics (1.1).In patients 55 years or older at high risk of developing a major cardiovascular event, ramipril is indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes (1.2).Ramipril is indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction (1.3).",
"Description": "Ramipril, USP is a 2‑aza‑bicyclo [3.3.0]‑octane‑3‑carboxylic acid derivative. It is a white to almost white, crystalline powder freely soluble in methanol. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2S,3aS,6aS)‑1-[(S)‑N‑[(S)‑1-Carboxy‑3‑phenylpropyl]alanyl]octahydrocyclopenta[b]pyrrole‑2‑carboxylic acid, 1‑ethyl ester. Ramipril Capsules, USP are available for oral administration containing either 1.25 mg, 2.5 mg, 5 mg or 10 mg ramipril, USP and the following inactive ingredient: pregelatinized starch. Each capsule shell contains black monogramming ink, gelatin and titanium dioxide. The black monogramming ink contains: black iron oxide, FD&C blue #2, FD&C red #40, FD&C yellow #6, propylene glycol and shellac glaze. The 1.25 mg capsule shell contains D&C yellow #10 and FD&C yellow #6. The 2.5 mg capsule shell contains FD&C yellow #6. The 5 mg capsule shell contains D&C red #28, FD&C blue #1 and FD&C yellow #6. The 10 mg capsule shell contains D&C red #28 and FD&C blue #1. The structural formula for ramipril is. Its molecular formula is C23H32N2O5, and its molecular weight is 416.51. Ramiprilat, the diacid metabolite of ramipril, is a non‑sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group."
},
{
"NDCCode": "0054-0108-25",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0054-0108-25) ",
"NDC11Code": "00054-0108-25",
"ProductNDC": "0054-0108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramipril",
"NonProprietaryName": "Ramipril",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20080618",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077900",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "RAMIPRIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080618",
"SamplePackage": "N",
"IndicationAndUsage": "Ramipril is an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics (1.1).In patients 55 years or older at high risk of developing a major cardiovascular event, ramipril is indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes (1.2).Ramipril is indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction (1.3).",
"Description": "Ramipril, USP is a 2‑aza‑bicyclo [3.3.0]‑octane‑3‑carboxylic acid derivative. It is a white to almost white, crystalline powder freely soluble in methanol. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2S,3aS,6aS)‑1-[(S)‑N‑[(S)‑1-Carboxy‑3‑phenylpropyl]alanyl]octahydrocyclopenta[b]pyrrole‑2‑carboxylic acid, 1‑ethyl ester. Ramipril Capsules, USP are available for oral administration containing either 1.25 mg, 2.5 mg, 5 mg or 10 mg ramipril, USP and the following inactive ingredient: pregelatinized starch. Each capsule shell contains black monogramming ink, gelatin and titanium dioxide. The black monogramming ink contains: black iron oxide, FD&C blue #2, FD&C red #40, FD&C yellow #6, propylene glycol and shellac glaze. The 1.25 mg capsule shell contains D&C yellow #10 and FD&C yellow #6. The 2.5 mg capsule shell contains FD&C yellow #6. The 5 mg capsule shell contains D&C red #28, FD&C blue #1 and FD&C yellow #6. The 10 mg capsule shell contains D&C red #28 and FD&C blue #1. The structural formula for ramipril is. Its molecular formula is C23H32N2O5, and its molecular weight is 416.51. Ramiprilat, the diacid metabolite of ramipril, is a non‑sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group."
},
{
"NDCCode": "0054-0108-29",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (0054-0108-29) ",
"NDC11Code": "00054-0108-29",
"ProductNDC": "0054-0108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramipril",
"NonProprietaryName": "Ramipril",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20080618",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077900",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "RAMIPRIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080618",
"SamplePackage": "N",
"IndicationAndUsage": "Ramipril is an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics (1.1).In patients 55 years or older at high risk of developing a major cardiovascular event, ramipril is indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes (1.2).Ramipril is indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction (1.3).",
"Description": "Ramipril, USP is a 2‑aza‑bicyclo [3.3.0]‑octane‑3‑carboxylic acid derivative. It is a white to almost white, crystalline powder freely soluble in methanol. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2S,3aS,6aS)‑1-[(S)‑N‑[(S)‑1-Carboxy‑3‑phenylpropyl]alanyl]octahydrocyclopenta[b]pyrrole‑2‑carboxylic acid, 1‑ethyl ester. Ramipril Capsules, USP are available for oral administration containing either 1.25 mg, 2.5 mg, 5 mg or 10 mg ramipril, USP and the following inactive ingredient: pregelatinized starch. Each capsule shell contains black monogramming ink, gelatin and titanium dioxide. The black monogramming ink contains: black iron oxide, FD&C blue #2, FD&C red #40, FD&C yellow #6, propylene glycol and shellac glaze. The 1.25 mg capsule shell contains D&C yellow #10 and FD&C yellow #6. The 2.5 mg capsule shell contains FD&C yellow #6. The 5 mg capsule shell contains D&C red #28, FD&C blue #1 and FD&C yellow #6. The 10 mg capsule shell contains D&C red #28 and FD&C blue #1. The structural formula for ramipril is. Its molecular formula is C23H32N2O5, and its molecular weight is 416.51. Ramiprilat, the diacid metabolite of ramipril, is a non‑sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group."
},
{
"NDCCode": "0054-0109-25",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0054-0109-25) ",
"NDC11Code": "00054-0109-25",
"ProductNDC": "0054-0109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramipril",
"NonProprietaryName": "Ramipril",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20080618",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077900",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "RAMIPRIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080618",
"SamplePackage": "N",
"IndicationAndUsage": "Ramipril is an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics (1.1).In patients 55 years or older at high risk of developing a major cardiovascular event, ramipril is indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes (1.2).Ramipril is indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction (1.3).",
"Description": "Ramipril, USP is a 2‑aza‑bicyclo [3.3.0]‑octane‑3‑carboxylic acid derivative. It is a white to almost white, crystalline powder freely soluble in methanol. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2S,3aS,6aS)‑1-[(S)‑N‑[(S)‑1-Carboxy‑3‑phenylpropyl]alanyl]octahydrocyclopenta[b]pyrrole‑2‑carboxylic acid, 1‑ethyl ester. Ramipril Capsules, USP are available for oral administration containing either 1.25 mg, 2.5 mg, 5 mg or 10 mg ramipril, USP and the following inactive ingredient: pregelatinized starch. Each capsule shell contains black monogramming ink, gelatin and titanium dioxide. The black monogramming ink contains: black iron oxide, FD&C blue #2, FD&C red #40, FD&C yellow #6, propylene glycol and shellac glaze. The 1.25 mg capsule shell contains D&C yellow #10 and FD&C yellow #6. The 2.5 mg capsule shell contains FD&C yellow #6. The 5 mg capsule shell contains D&C red #28, FD&C blue #1 and FD&C yellow #6. The 10 mg capsule shell contains D&C red #28 and FD&C blue #1. The structural formula for ramipril is. Its molecular formula is C23H32N2O5, and its molecular weight is 416.51. Ramiprilat, the diacid metabolite of ramipril, is a non‑sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group."
},
{
"NDCCode": "0054-0109-29",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (0054-0109-29) ",
"NDC11Code": "00054-0109-29",
"ProductNDC": "0054-0109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramipril",
"NonProprietaryName": "Ramipril",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20080618",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077900",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "RAMIPRIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080618",
"SamplePackage": "N",
"IndicationAndUsage": "Ramipril is an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics (1.1).In patients 55 years or older at high risk of developing a major cardiovascular event, ramipril is indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes (1.2).Ramipril is indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction (1.3).",
"Description": "Ramipril, USP is a 2‑aza‑bicyclo [3.3.0]‑octane‑3‑carboxylic acid derivative. It is a white to almost white, crystalline powder freely soluble in methanol. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2S,3aS,6aS)‑1-[(S)‑N‑[(S)‑1-Carboxy‑3‑phenylpropyl]alanyl]octahydrocyclopenta[b]pyrrole‑2‑carboxylic acid, 1‑ethyl ester. Ramipril Capsules, USP are available for oral administration containing either 1.25 mg, 2.5 mg, 5 mg or 10 mg ramipril, USP and the following inactive ingredient: pregelatinized starch. Each capsule shell contains black monogramming ink, gelatin and titanium dioxide. The black monogramming ink contains: black iron oxide, FD&C blue #2, FD&C red #40, FD&C yellow #6, propylene glycol and shellac glaze. The 1.25 mg capsule shell contains D&C yellow #10 and FD&C yellow #6. The 2.5 mg capsule shell contains FD&C yellow #6. The 5 mg capsule shell contains D&C red #28, FD&C blue #1 and FD&C yellow #6. The 10 mg capsule shell contains D&C red #28 and FD&C blue #1. The structural formula for ramipril is. Its molecular formula is C23H32N2O5, and its molecular weight is 416.51. Ramiprilat, the diacid metabolite of ramipril, is a non‑sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group."
},
{
"NDCCode": "0054-0639-03",
"PackageDescription": "7 TABLET in 1 BOTTLE (0054-0639-03) ",
"NDC11Code": "00054-0639-03",
"ProductNDC": "0054-0639",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylergonovine Maleate",
"NonProprietaryName": "Methylergonovine Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180703",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210424",
"LabelerName": "West-Ward Pharmaceuticals Corp",
"SubstanceName": "METHYLERGONOVINE MALEATE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Ergolines [CS], Ergot Derivative [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180703",
"SamplePackage": "N",
"IndicationAndUsage": "Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.",
"Description": "Methylergonovine Maleate Tablets, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage. Methylergonovine Maleate Tablets, USP is available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate. Tablets Active ingredient: Methylergonovine maleate, USP, 0.2 mg. Inactive ingredients: acacia, corn starch, gelatin, lactose monohydrate, methylparaben, microcrystalline cellulose, povidone, propylparaben, stearic acid, and tartaric acid. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9, 10-didehydro-N-[1-(hydroxymethyl) propyl]-6-methyl-, [8β(S)]-, (Z)-2-butenedioate (1:1) (salt). Its structural formula is:. C 20H 25N 3O 2C 4H 4O 4 Mol Wt: 455.51."
},
{
"NDCCode": "0054-0639-05",
"PackageDescription": "12 TABLET in 1 BOTTLE (0054-0639-05) ",
"NDC11Code": "00054-0639-05",
"ProductNDC": "0054-0639",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylergonovine Maleate",
"NonProprietaryName": "Methylergonovine Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180703",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210424",
"LabelerName": "West-Ward Pharmaceuticals Corp",
"SubstanceName": "METHYLERGONOVINE MALEATE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Ergolines [CS], Ergot Derivative [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180703",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.",
"Description": "Methylergonovine Maleate Tablets, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage. Methylergonovine Maleate Tablets, USP is available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate. Tablets. Active ingredient: Methylergonovine maleate, USP, 0.2 mg. Inactive ingredients: acacia, corn starch, gelatin, lactose monohydrate, methylparaben, microcrystalline cellulose, povidone, propylparaben, stearic acid, and tartaric acid. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9, 10-didehydro-N-[1-(hydroxymethyl) propyl]-6-methyl-, [8β(S)]-, (Z)-2-butenedioate (1:1) (salt). Its structural formula is:. C20H25N3O2C4H4O4 Mol Wt: 455.51."
},
{
"NDCCode": "0054-0639-13",
"PackageDescription": "28 TABLET in 1 BOTTLE (0054-0639-13) ",
"NDC11Code": "00054-0639-13",
"ProductNDC": "0054-0639",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylergonovine Maleate",
"NonProprietaryName": "Methylergonovine Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180703",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210424",
"LabelerName": "West-Ward Pharmaceuticals Corp",
"SubstanceName": "METHYLERGONOVINE MALEATE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Ergolines [CS], Ergot Derivative [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180703",
"SamplePackage": "N",
"IndicationAndUsage": "Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.",
"Description": "Methylergonovine Maleate Tablets, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage. Methylergonovine Maleate Tablets, USP is available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate. Tablets Active ingredient: Methylergonovine maleate, USP, 0.2 mg. Inactive ingredients: acacia, corn starch, gelatin, lactose monohydrate, methylparaben, microcrystalline cellulose, povidone, propylparaben, stearic acid, and tartaric acid. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9, 10-didehydro-N-[1-(hydroxymethyl) propyl]-6-methyl-, [8β(S)]-, (Z)-2-butenedioate (1:1) (salt). Its structural formula is:. C 20H 25N 3O 2C 4H 4O 4 Mol Wt: 455.51."
},
{
"NDCCode": "0054-0639-25",
"PackageDescription": "100 TABLET in 1 BOTTLE (0054-0639-25) ",
"NDC11Code": "00054-0639-25",
"ProductNDC": "0054-0639",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylergonovine Maleate",
"NonProprietaryName": "Methylergonovine Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180703",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210424",
"LabelerName": "West-Ward Pharmaceuticals Corp",
"SubstanceName": "METHYLERGONOVINE MALEATE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Ergolines [CS], Ergot Derivative [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180703",
"SamplePackage": "N",
"IndicationAndUsage": "Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.",
"Description": "Methylergonovine Maleate Tablets, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage. Methylergonovine Maleate Tablets, USP is available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate. Tablets Active ingredient: Methylergonovine maleate, USP, 0.2 mg. Inactive ingredients: acacia, corn starch, gelatin, lactose monohydrate, methylparaben, microcrystalline cellulose, povidone, propylparaben, stearic acid, and tartaric acid. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9, 10-didehydro-N-[1-(hydroxymethyl) propyl]-6-methyl-, [8β(S)]-, (Z)-2-butenedioate (1:1) (salt). Its structural formula is:. C 20H 25N 3O 2C 4H 4O 4 Mol Wt: 455.51."
},
{
"NDCCode": "0054-4496-13",
"PackageDescription": "30 TABLET in 1 BOTTLE (0054-4496-13) ",
"NDC11Code": "00054-4496-13",
"ProductNDC": "0054-4496",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Leucovorin Calcium",
"NonProprietaryName": "Leucovorin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19930222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072733",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "LEUCOVORIN CALCIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19930322",
"SamplePackage": "N",
"IndicationAndUsage": "Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5 Limitations of Use, 6 Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).",
"Description": "Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch."
},
{
"NDCCode": "0054-4496-25",
"PackageDescription": "100 TABLET in 1 BOTTLE (0054-4496-25) ",
"NDC11Code": "00054-4496-25",
"ProductNDC": "0054-4496",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Leucovorin Calcium",
"NonProprietaryName": "Leucovorin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19930222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072733",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "LEUCOVORIN CALCIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19930322",
"SamplePackage": "N",
"IndicationAndUsage": "Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5 Limitations of Use, 6 Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).",
"Description": "Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch."
},
{
"NDCCode": "0054-4497-05",
"PackageDescription": "12 TABLET in 1 BOTTLE (0054-4497-05) ",
"NDC11Code": "00054-4497-05",
"ProductNDC": "0054-4497",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Leucovorin Calcium",
"NonProprietaryName": "Leucovorin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19930222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072734",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "LEUCOVORIN CALCIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19930322",
"SamplePackage": "N",
"IndicationAndUsage": "Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5 Limitations of Use, 6 Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).",
"Description": "Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch."
},
{
"NDCCode": "0054-4497-10",
"PackageDescription": "24 TABLET in 1 BOTTLE (0054-4497-10) ",
"NDC11Code": "00054-4497-10",
"ProductNDC": "0054-4497",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Leucovorin Calcium",
"NonProprietaryName": "Leucovorin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19930222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072734",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "LEUCOVORIN CALCIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19930322",
"SamplePackage": "N",
"IndicationAndUsage": "Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5 Limitations of Use, 6 Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).",
"Description": "Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch."
},
{
"NDCCode": "0054-4498-10",
"PackageDescription": "24 TABLET in 1 BOTTLE (0054-4498-10) ",
"NDC11Code": "00054-4498-10",
"ProductNDC": "0054-4498",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Leucovorin Calcium",
"NonProprietaryName": "Leucovorin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19930222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072735",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "LEUCOVORIN CALCIUM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19930322",
"SamplePackage": "N",
"IndicationAndUsage": "Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5 Limitations of Use, 6 Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).",
"Description": "Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch."
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{
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"Description": "Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch."
},
{
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"ProductNDC": "0054-8496",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072733",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
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"IndicationAndUsage": "Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5 Limitations of Use, 6 Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).",
"Description": "Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch."
},
{
"NDCCode": "45802-054-05",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087385",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
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"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene) bis (oxy)]-,(11β,16α)-. C24H31FO6, M.W. 434.51; CAS Reg. No. 76-25-5. Each gram of Triamcinolone Acetonide Ointment USP, 0.025%, 0.1% or 0.5% contains 0.25 mg, 1 mg or 5 mg triamcinolone acetonide, respectively, in an ointment base of light mineral oil and white petrolatum."
},
{
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"NDC11Code": "45802-0054-35",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"ApplicationNumber": "ANDA087385",
"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
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"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene) bis (oxy)]-,(11β,16α)-. C24H31FO6, M.W. 434.51; CAS Reg. No. 76-25-5. Each gram of Triamcinolone Acetonide Ointment USP, 0.025%, 0.1% or 0.5% contains 0.25 mg, 1 mg or 5 mg triamcinolone acetonide, respectively, in an ointment base of light mineral oil and white petrolatum."
},
{
"NDCCode": "45802-054-36",
"PackageDescription": "1 TUBE in 1 CARTON (45802-054-36) / 80 g in 1 TUBE",
"NDC11Code": "45802-0054-36",
"ProductNDC": "45802-054",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Padagis Israel Pharmaceuticals Ltd",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
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"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene) bis (oxy)]-,(11β,16α)-. C24H31FO6, M.W. 434.51; CAS Reg. No. 76-25-5. Each gram of Triamcinolone Acetonide Ointment USP, 0.025%, 0.1% or 0.5% contains 0.25 mg, 1 mg or 5 mg triamcinolone acetonide, respectively, in an ointment base of light mineral oil and white petrolatum."
},
{
"NDCCode": "49452-4858-1",
"PackageDescription": "5 g in 1 BOTTLE (49452-4858-1) ",
"NDC11Code": "49452-4858-01",
"ProductNDC": "49452-4858",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Nortriptyline Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "19970801",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Spectrum Laboratory Products, Inc.",
"SubstanceName": "NORTRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
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"LastUpdate": "2026-08-25",
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"EndMarketingDatePackage": "31-DEC-26"
},
{
"NDCCode": "49452-4858-2",
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"ProductNDC": "49452-4858",
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"SubstanceName": "NORTRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Unfinished",
"LastUpdate": "2026-08-25",
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"EndMarketingDatePackage": "31-DEC-26"
},
{
"NDCCode": "49452-4858-3",
"PackageDescription": "100 g in 1 BOTTLE (49452-4858-3) ",
"NDC11Code": "49452-4858-03",
"ProductNDC": "49452-4858",
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}
]
}
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triazolam</ProprietaryName>
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<LastUpdate>2015-01-16</LastUpdate>
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<NDC>
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<PackageDescription>100 TABLET in 1 BOTTLE (0054-4858-25) </PackageDescription>
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<ProductNDC>0054-4858</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<StartMarketingDatePackage>20181029</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Triazolam is indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults.</IndicationAndUsage>
<Description>Triazolam Tablets, USP contain triazolam, a triazolobenzodiazepine. Triazolam, USP is a white to off-white powder, soluble in chloroform; slightly soluble in alcohol; and practically insoluble in ether and in water. It has a molecular weight of 343.2. The chemical name for triazolam is 8-chloro-6-(o-chlorophenyl)-1-methyl-4H-s-triazolo-[4,3-α][1,4]benzodiazepine. The structural formula is represented below: 1 .</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Polystyrene Sulfonate</ProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>West-Ward Pharmaceuticals Corp.</LabelerName>
<SubstanceName>SODIUM POLYSTYRENE SULFONATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>g/60mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-02-02</LastUpdate>
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<NDCCode>70257-054-51</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (70257-054-51) / 5 mL in 1 VIAL, GLASS (70257-054-05) </PackageDescription>
<NDC11Code>70257-0054-51</NDC11Code>
<ProductNDC>70257-054</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hepagam B</ProprietaryName>
<NonProprietaryName>Human Hepatitis B Virus Immune Globulin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
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<EndMarketingDate>20240430</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
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<LabelerName>Saol Therapeutics Inc.</LabelerName>
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<Status>Deprecated</Status>
<LastUpdate>2024-05-01</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDate>20080618</StartMarketingDate>
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<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
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<LastUpdate>2026-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<Description>Ramipril, USP is a 2‑aza‑bicyclo [3.3.0]‑octane‑3‑carboxylic acid derivative. It is a white to almost white, crystalline powder freely soluble in methanol. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2S,3aS,6aS)‑1-[(S)‑N‑[(S)‑1-Carboxy‑3‑phenylpropyl]alanyl]octahydrocyclopenta[b]pyrrole‑2‑carboxylic acid, 1‑ethyl ester. Ramipril Capsules, USP are available for oral administration containing either 1.25 mg, 2.5 mg, 5 mg or 10 mg ramipril, USP and the following inactive ingredient: pregelatinized starch. Each capsule shell contains black monogramming ink, gelatin and titanium dioxide. The black monogramming ink contains: black iron oxide, FD&C blue #2, FD&C red #40, FD&C yellow #6, propylene glycol and shellac glaze. The 1.25 mg capsule shell contains D&C yellow #10 and FD&C yellow #6. The 2.5 mg capsule shell contains FD&C yellow #6. The 5 mg capsule shell contains D&C red #28, FD&C blue #1 and FD&C yellow #6. The 10 mg capsule shell contains D&C red #28 and FD&C blue #1. The structural formula for ramipril is. Its molecular formula is C23H32N2O5, and its molecular weight is 416.51. Ramiprilat, the diacid metabolite of ramipril, is a non‑sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group.</Description>
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<NDCCode>0054-0107-20</NDCCode>
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<ProductNDC>0054-0107</ProductNDC>
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<IndicationAndUsage>Ramipril is an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics (1.1).In patients 55 years or older at high risk of developing a major cardiovascular event, ramipril is indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes (1.2).Ramipril is indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction (1.3).</IndicationAndUsage>
<Description>Ramipril, USP is a 2‑aza‑bicyclo [3.3.0]‑octane‑3‑carboxylic acid derivative. It is a white to almost white, crystalline powder freely soluble in methanol. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2S,3aS,6aS)‑1-[(S)‑N‑[(S)‑1-Carboxy‑3‑phenylpropyl]alanyl]octahydrocyclopenta[b]pyrrole‑2‑carboxylic acid, 1‑ethyl ester. Ramipril Capsules, USP are available for oral administration containing either 1.25 mg, 2.5 mg, 5 mg or 10 mg ramipril, USP and the following inactive ingredient: pregelatinized starch. Each capsule shell contains black monogramming ink, gelatin and titanium dioxide. The black monogramming ink contains: black iron oxide, FD&C blue #2, FD&C red #40, FD&C yellow #6, propylene glycol and shellac glaze. The 1.25 mg capsule shell contains D&C yellow #10 and FD&C yellow #6. The 2.5 mg capsule shell contains FD&C yellow #6. The 5 mg capsule shell contains D&C red #28, FD&C blue #1 and FD&C yellow #6. The 10 mg capsule shell contains D&C red #28 and FD&C blue #1. The structural formula for ramipril is. Its molecular formula is C23H32N2O5, and its molecular weight is 416.51. Ramiprilat, the diacid metabolite of ramipril, is a non‑sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group.</Description>
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<IndicationAndUsage>Ramipril is an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics (1.1).In patients 55 years or older at high risk of developing a major cardiovascular event, ramipril is indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes (1.2).Ramipril is indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction (1.3).</IndicationAndUsage>
<Description>Ramipril, USP is a 2‑aza‑bicyclo [3.3.0]‑octane‑3‑carboxylic acid derivative. It is a white to almost white, crystalline powder freely soluble in methanol. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2S,3aS,6aS)‑1-[(S)‑N‑[(S)‑1-Carboxy‑3‑phenylpropyl]alanyl]octahydrocyclopenta[b]pyrrole‑2‑carboxylic acid, 1‑ethyl ester. Ramipril Capsules, USP are available for oral administration containing either 1.25 mg, 2.5 mg, 5 mg or 10 mg ramipril, USP and the following inactive ingredient: pregelatinized starch. Each capsule shell contains black monogramming ink, gelatin and titanium dioxide. The black monogramming ink contains: black iron oxide, FD&C blue #2, FD&C red #40, FD&C yellow #6, propylene glycol and shellac glaze. The 1.25 mg capsule shell contains D&C yellow #10 and FD&C yellow #6. The 2.5 mg capsule shell contains FD&C yellow #6. The 5 mg capsule shell contains D&C red #28, FD&C blue #1 and FD&C yellow #6. The 10 mg capsule shell contains D&C red #28 and FD&C blue #1. The structural formula for ramipril is. Its molecular formula is C23H32N2O5, and its molecular weight is 416.51. Ramiprilat, the diacid metabolite of ramipril, is a non‑sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group.</Description>
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<IndicationAndUsage>Ramipril is an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics (1.1).In patients 55 years or older at high risk of developing a major cardiovascular event, ramipril is indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes (1.2).Ramipril is indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction (1.3).</IndicationAndUsage>
<Description>Ramipril, USP is a 2‑aza‑bicyclo [3.3.0]‑octane‑3‑carboxylic acid derivative. It is a white to almost white, crystalline powder freely soluble in methanol. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2S,3aS,6aS)‑1-[(S)‑N‑[(S)‑1-Carboxy‑3‑phenylpropyl]alanyl]octahydrocyclopenta[b]pyrrole‑2‑carboxylic acid, 1‑ethyl ester. Ramipril Capsules, USP are available for oral administration containing either 1.25 mg, 2.5 mg, 5 mg or 10 mg ramipril, USP and the following inactive ingredient: pregelatinized starch. Each capsule shell contains black monogramming ink, gelatin and titanium dioxide. The black monogramming ink contains: black iron oxide, FD&C blue #2, FD&C red #40, FD&C yellow #6, propylene glycol and shellac glaze. The 1.25 mg capsule shell contains D&C yellow #10 and FD&C yellow #6. The 2.5 mg capsule shell contains FD&C yellow #6. The 5 mg capsule shell contains D&C red #28, FD&C blue #1 and FD&C yellow #6. The 10 mg capsule shell contains D&C red #28 and FD&C blue #1. The structural formula for ramipril is. Its molecular formula is C23H32N2O5, and its molecular weight is 416.51. Ramiprilat, the diacid metabolite of ramipril, is a non‑sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group.</Description>
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<IndicationAndUsage>Ramipril is an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics (1.1).In patients 55 years or older at high risk of developing a major cardiovascular event, ramipril is indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes (1.2).Ramipril is indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction (1.3).</IndicationAndUsage>
<Description>Ramipril, USP is a 2‑aza‑bicyclo [3.3.0]‑octane‑3‑carboxylic acid derivative. It is a white to almost white, crystalline powder freely soluble in methanol. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2S,3aS,6aS)‑1-[(S)‑N‑[(S)‑1-Carboxy‑3‑phenylpropyl]alanyl]octahydrocyclopenta[b]pyrrole‑2‑carboxylic acid, 1‑ethyl ester. Ramipril Capsules, USP are available for oral administration containing either 1.25 mg, 2.5 mg, 5 mg or 10 mg ramipril, USP and the following inactive ingredient: pregelatinized starch. Each capsule shell contains black monogramming ink, gelatin and titanium dioxide. The black monogramming ink contains: black iron oxide, FD&C blue #2, FD&C red #40, FD&C yellow #6, propylene glycol and shellac glaze. The 1.25 mg capsule shell contains D&C yellow #10 and FD&C yellow #6. The 2.5 mg capsule shell contains FD&C yellow #6. The 5 mg capsule shell contains D&C red #28, FD&C blue #1 and FD&C yellow #6. The 10 mg capsule shell contains D&C red #28 and FD&C blue #1. The structural formula for ramipril is. Its molecular formula is C23H32N2O5, and its molecular weight is 416.51. Ramiprilat, the diacid metabolite of ramipril, is a non‑sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group.</Description>
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<IndicationAndUsage>Ramipril is an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics (1.1).In patients 55 years or older at high risk of developing a major cardiovascular event, ramipril is indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes (1.2).Ramipril is indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction (1.3).</IndicationAndUsage>
<Description>Ramipril, USP is a 2‑aza‑bicyclo [3.3.0]‑octane‑3‑carboxylic acid derivative. It is a white to almost white, crystalline powder freely soluble in methanol. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2S,3aS,6aS)‑1-[(S)‑N‑[(S)‑1-Carboxy‑3‑phenylpropyl]alanyl]octahydrocyclopenta[b]pyrrole‑2‑carboxylic acid, 1‑ethyl ester. Ramipril Capsules, USP are available for oral administration containing either 1.25 mg, 2.5 mg, 5 mg or 10 mg ramipril, USP and the following inactive ingredient: pregelatinized starch. Each capsule shell contains black monogramming ink, gelatin and titanium dioxide. The black monogramming ink contains: black iron oxide, FD&C blue #2, FD&C red #40, FD&C yellow #6, propylene glycol and shellac glaze. The 1.25 mg capsule shell contains D&C yellow #10 and FD&C yellow #6. The 2.5 mg capsule shell contains FD&C yellow #6. The 5 mg capsule shell contains D&C red #28, FD&C blue #1 and FD&C yellow #6. The 10 mg capsule shell contains D&C red #28 and FD&C blue #1. The structural formula for ramipril is. Its molecular formula is C23H32N2O5, and its molecular weight is 416.51. Ramiprilat, the diacid metabolite of ramipril, is a non‑sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group.</Description>
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<Description>Ramipril, USP is a 2‑aza‑bicyclo [3.3.0]‑octane‑3‑carboxylic acid derivative. It is a white to almost white, crystalline powder freely soluble in methanol. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2S,3aS,6aS)‑1-[(S)‑N‑[(S)‑1-Carboxy‑3‑phenylpropyl]alanyl]octahydrocyclopenta[b]pyrrole‑2‑carboxylic acid, 1‑ethyl ester. Ramipril Capsules, USP are available for oral administration containing either 1.25 mg, 2.5 mg, 5 mg or 10 mg ramipril, USP and the following inactive ingredient: pregelatinized starch. Each capsule shell contains black monogramming ink, gelatin and titanium dioxide. The black monogramming ink contains: black iron oxide, FD&C blue #2, FD&C red #40, FD&C yellow #6, propylene glycol and shellac glaze. The 1.25 mg capsule shell contains D&C yellow #10 and FD&C yellow #6. The 2.5 mg capsule shell contains FD&C yellow #6. The 5 mg capsule shell contains D&C red #28, FD&C blue #1 and FD&C yellow #6. The 10 mg capsule shell contains D&C red #28 and FD&C blue #1. The structural formula for ramipril is. Its molecular formula is C23H32N2O5, and its molecular weight is 416.51. Ramiprilat, the diacid metabolite of ramipril, is a non‑sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group.</Description>
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<IndicationAndUsage>Ramipril is an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics (1.1).In patients 55 years or older at high risk of developing a major cardiovascular event, ramipril is indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes (1.2).Ramipril is indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction (1.3).</IndicationAndUsage>
<Description>Ramipril, USP is a 2‑aza‑bicyclo [3.3.0]‑octane‑3‑carboxylic acid derivative. It is a white to almost white, crystalline powder freely soluble in methanol. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2S,3aS,6aS)‑1-[(S)‑N‑[(S)‑1-Carboxy‑3‑phenylpropyl]alanyl]octahydrocyclopenta[b]pyrrole‑2‑carboxylic acid, 1‑ethyl ester. Ramipril Capsules, USP are available for oral administration containing either 1.25 mg, 2.5 mg, 5 mg or 10 mg ramipril, USP and the following inactive ingredient: pregelatinized starch. Each capsule shell contains black monogramming ink, gelatin and titanium dioxide. The black monogramming ink contains: black iron oxide, FD&C blue #2, FD&C red #40, FD&C yellow #6, propylene glycol and shellac glaze. The 1.25 mg capsule shell contains D&C yellow #10 and FD&C yellow #6. The 2.5 mg capsule shell contains FD&C yellow #6. The 5 mg capsule shell contains D&C red #28, FD&C blue #1 and FD&C yellow #6. The 10 mg capsule shell contains D&C red #28 and FD&C blue #1. The structural formula for ramipril is. Its molecular formula is C23H32N2O5, and its molecular weight is 416.51. Ramiprilat, the diacid metabolite of ramipril, is a non‑sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group.</Description>
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<IndicationAndUsage>Ramipril is an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics (1.1).In patients 55 years or older at high risk of developing a major cardiovascular event, ramipril is indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes (1.2).Ramipril is indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction (1.3).</IndicationAndUsage>
<Description>Ramipril, USP is a 2‑aza‑bicyclo [3.3.0]‑octane‑3‑carboxylic acid derivative. It is a white to almost white, crystalline powder freely soluble in methanol. Ramipril melts between 105°C to 112°C. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2S,3aS,6aS)‑1-[(S)‑N‑[(S)‑1-Carboxy‑3‑phenylpropyl]alanyl]octahydrocyclopenta[b]pyrrole‑2‑carboxylic acid, 1‑ethyl ester. Ramipril Capsules, USP are available for oral administration containing either 1.25 mg, 2.5 mg, 5 mg or 10 mg ramipril, USP and the following inactive ingredient: pregelatinized starch. Each capsule shell contains black monogramming ink, gelatin and titanium dioxide. The black monogramming ink contains: black iron oxide, FD&C blue #2, FD&C red #40, FD&C yellow #6, propylene glycol and shellac glaze. The 1.25 mg capsule shell contains D&C yellow #10 and FD&C yellow #6. The 2.5 mg capsule shell contains FD&C yellow #6. The 5 mg capsule shell contains D&C red #28, FD&C blue #1 and FD&C yellow #6. The 10 mg capsule shell contains D&C red #28 and FD&C blue #1. The structural formula for ramipril is. Its molecular formula is C23H32N2O5, and its molecular weight is 416.51. Ramiprilat, the diacid metabolite of ramipril, is a non‑sulfhydryl ACE inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group.</Description>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.</IndicationAndUsage>
<Description>Methylergonovine Maleate Tablets, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage. Methylergonovine Maleate Tablets, USP is available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate. Tablets Active ingredient: Methylergonovine maleate, USP, 0.2 mg. Inactive ingredients: acacia, corn starch, gelatin, lactose monohydrate, methylparaben, microcrystalline cellulose, povidone, propylparaben, stearic acid, and tartaric acid. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9, 10-didehydro-N-[1-(hydroxymethyl) propyl]-6-methyl-, [8β(S)]-, (Z)-2-butenedioate (1:1) (salt). Its structural formula is:. C 20H 25N 3O 2C 4H 4O 4 Mol Wt: 455.51.</Description>
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<IndicationAndUsage>Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.</IndicationAndUsage>
<Description>Methylergonovine Maleate Tablets, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage. Methylergonovine Maleate Tablets, USP is available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate. Tablets. Active ingredient: Methylergonovine maleate, USP, 0.2 mg. Inactive ingredients: acacia, corn starch, gelatin, lactose monohydrate, methylparaben, microcrystalline cellulose, povidone, propylparaben, stearic acid, and tartaric acid. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9, 10-didehydro-N-[1-(hydroxymethyl) propyl]-6-methyl-, [8β(S)]-, (Z)-2-butenedioate (1:1) (salt). Its structural formula is:. C20H25N3O2C4H4O4 Mol Wt: 455.51.</Description>
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<IndicationAndUsage>Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.</IndicationAndUsage>
<Description>Methylergonovine Maleate Tablets, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage. Methylergonovine Maleate Tablets, USP is available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate. Tablets Active ingredient: Methylergonovine maleate, USP, 0.2 mg. Inactive ingredients: acacia, corn starch, gelatin, lactose monohydrate, methylparaben, microcrystalline cellulose, povidone, propylparaben, stearic acid, and tartaric acid. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9, 10-didehydro-N-[1-(hydroxymethyl) propyl]-6-methyl-, [8β(S)]-, (Z)-2-butenedioate (1:1) (salt). Its structural formula is:. C 20H 25N 3O 2C 4H 4O 4 Mol Wt: 455.51.</Description>
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<IndicationAndUsage>Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.</IndicationAndUsage>
<Description>Methylergonovine Maleate Tablets, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage. Methylergonovine Maleate Tablets, USP is available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate. Tablets Active ingredient: Methylergonovine maleate, USP, 0.2 mg. Inactive ingredients: acacia, corn starch, gelatin, lactose monohydrate, methylparaben, microcrystalline cellulose, povidone, propylparaben, stearic acid, and tartaric acid. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9, 10-didehydro-N-[1-(hydroxymethyl) propyl]-6-methyl-, [8β(S)]-, (Z)-2-butenedioate (1:1) (salt). Its structural formula is:. C 20H 25N 3O 2C 4H 4O 4 Mol Wt: 455.51.</Description>
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<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
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<IndicationAndUsage>Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5 Limitations of Use, 6 Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).</IndicationAndUsage>
<Description>Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch.</Description>
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<IndicationAndUsage>Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5 Limitations of Use, 6 Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).</IndicationAndUsage>
<Description>Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch.</Description>
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<IndicationAndUsage>Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5 Limitations of Use, 6 Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).</IndicationAndUsage>
<Description>Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch.</Description>
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<IndicationAndUsage>Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5 Limitations of Use, 6 Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).</IndicationAndUsage>
<Description>Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch.</Description>
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<IndicationAndUsage>Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5 Limitations of Use, 6 Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).</IndicationAndUsage>
<Description>Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch.</Description>
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<IndicationAndUsage>Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5 Limitations of Use, 6 Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).</IndicationAndUsage>
<Description>Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch.</Description>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5 Limitations of Use, 6 Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).</IndicationAndUsage>
<Description>Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch.</Description>
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<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
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<StartMarketingDate>20060512</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087385</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
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<LastUpdate>2023-11-04</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene) bis (oxy)]-,(11β,16α)-. C24H31FO6, M.W. 434.51; CAS Reg. No. 76-25-5. Each gram of Triamcinolone Acetonide Ointment USP, 0.025%, 0.1% or 0.5% contains 0.25 mg, 1 mg or 5 mg triamcinolone acetonide, respectively, in an ointment base of light mineral oil and white petrolatum.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
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<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060512</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087385</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene) bis (oxy)]-,(11β,16α)-. C24H31FO6, M.W. 434.51; CAS Reg. No. 76-25-5. Each gram of Triamcinolone Acetonide Ointment USP, 0.025%, 0.1% or 0.5% contains 0.25 mg, 1 mg or 5 mg triamcinolone acetonide, respectively, in an ointment base of light mineral oil and white petrolatum.</Description>
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<PackageDescription>1 TUBE in 1 CARTON (45802-054-36) / 80 g in 1 TUBE</PackageDescription>
<NDC11Code>45802-0054-36</NDC11Code>
<ProductNDC>45802-054</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060512</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087385</ApplicationNumber>
<LabelerName>Padagis Israel Pharmaceuticals Ltd</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene) bis (oxy)]-,(11β,16α)-. C24H31FO6, M.W. 434.51; CAS Reg. No. 76-25-5. Each gram of Triamcinolone Acetonide Ointment USP, 0.025%, 0.1% or 0.5% contains 0.25 mg, 1 mg or 5 mg triamcinolone acetonide, respectively, in an ointment base of light mineral oil and white petrolatum.</Description>
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<NDCCode>49452-4858-1</NDCCode>
<PackageDescription>5 g in 1 BOTTLE (49452-4858-1) </PackageDescription>
<NDC11Code>49452-4858-01</NDC11Code>
<ProductNDC>49452-4858</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Nortriptyline Hydrochloride</NonProprietaryName>
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<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Spectrum Laboratory Products, Inc.</LabelerName>
<SubstanceName>NORTRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-08-25</LastUpdate>
<StartMarketingDatePackage>01-AUG-97</StartMarketingDatePackage>
<EndMarketingDatePackage>31-DEC-26</EndMarketingDatePackage>
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<NDCCode>49452-4858-2</NDCCode>
<PackageDescription>25 g in 1 BOTTLE (49452-4858-2) </PackageDescription>
<NDC11Code>49452-4858-02</NDC11Code>
<ProductNDC>49452-4858</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Nortriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19970801</StartMarketingDate>
<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Spectrum Laboratory Products, Inc.</LabelerName>
<SubstanceName>NORTRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-08-25</LastUpdate>
<StartMarketingDatePackage>01-AUG-97</StartMarketingDatePackage>
<EndMarketingDatePackage>31-DEC-26</EndMarketingDatePackage>
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<NDC>
<NDCCode>49452-4858-3</NDCCode>
<PackageDescription>100 g in 1 BOTTLE (49452-4858-3) </PackageDescription>
<NDC11Code>49452-4858-03</NDC11Code>
<ProductNDC>49452-4858</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Nortriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19970801</StartMarketingDate>
<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Spectrum Laboratory Products, Inc.</LabelerName>
<SubstanceName>NORTRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-08-25</LastUpdate>
<StartMarketingDatePackage>01-AUG-97</StartMarketingDatePackage>
<EndMarketingDatePackage>31-DEC-26</EndMarketingDatePackage>
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