{
"NDC": [
{
"NDCCode": "59746-463-32",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (59746-463-32) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "59746-0463-32",
"ProductNDC": "59746-463",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil",
"NonProprietaryName": "Olmesartan Medoxomil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205482",
"LabelerName": "Jubilant Cadista Pharmacuticals Inc.",
"SubstanceName": "OLMESARTAN MEDOXOMIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
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"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Olmesartan medoxomil, USP a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil, USP is described chemically as 4-(1-Hydroxy-1-methylethyl)-2 propyl-1-[2-(1H-5- tetrazolyl) biphenyl-4-ylmethyl] imidazole-5-carboxylic acid 5-methyl-2-oxo-1,3-dioxol-4- ylmethyl ester. Its empirical formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil, USP is a white to off-white powder with a molecular weight of 558.58. It is slightly soluble in acetone, methanol; very slightly soluble in ethanol; practically insoluble in water. Olmesartan medoxomil is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil, USP and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose,low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide, talc, and (5 mg only) ferric oxide yellow."
},
{
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"PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (47593-463-32) ",
"NDC11Code": "47593-0463-32",
"ProductNDC": "47593-463",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Scrub-stat",
"NonProprietaryName": "Chlorhexidine Gluconate",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "19860722",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019258",
"LabelerName": "Ecolab Inc.",
"SubstanceName": "CHLORHEXIDINE GLUCONATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Cell Wall Integrity [PE]",
"Status": "Active",
"LastUpdate": "2026-01-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19860722",
"SamplePackage": "N",
"IndicationAndUsage": "surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care. healthcare personnel handwash: handwash to help reduce bacteria that potentially can cause disease."
},
{
"NDCCode": "59746-463-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59746-463-01) ",
"NDC11Code": "59746-0463-01",
"ProductNDC": "59746-463",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil",
"NonProprietaryName": "Olmesartan Medoxomil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205482",
"LabelerName": "Jubilant Cadista Pharmacuticals Inc.",
"SubstanceName": "OLMESARTAN MEDOXOMIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170424",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Olmesartan medoxomil, USP a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil, USP is described chemically as 4-(1-Hydroxy-1-methylethyl)-2 propyl-1-[2-(1H-5- tetrazolyl) biphenyl-4-ylmethyl] imidazole-5-carboxylic acid 5-methyl-2-oxo-1,3-dioxol-4- ylmethyl ester. Its empirical formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil, USP is a white to off-white powder with a molecular weight of 558.58. It is slightly soluble in acetone, methanol; very slightly soluble in ethanol; practically insoluble in water. Olmesartan medoxomil is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil, USP and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose,low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide, talc, and (5 mg only) ferric oxide yellow."
},
{
"NDCCode": "59746-463-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59746-463-10) ",
"NDC11Code": "59746-0463-10",
"ProductNDC": "59746-463",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil",
"NonProprietaryName": "Olmesartan Medoxomil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205482",
"LabelerName": "Jubilant Cadista Pharmacuticals Inc.",
"SubstanceName": "OLMESARTAN MEDOXOMIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170424",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Olmesartan medoxomil, USP a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil, USP is described chemically as 4-(1-Hydroxy-1-methylethyl)-2 propyl-1-[2-(1H-5- tetrazolyl) biphenyl-4-ylmethyl] imidazole-5-carboxylic acid 5-methyl-2-oxo-1,3-dioxol-4- ylmethyl ester. Its empirical formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil, USP is a white to off-white powder with a molecular weight of 558.58. It is slightly soluble in acetone, methanol; very slightly soluble in ethanol; practically insoluble in water. Olmesartan medoxomil is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil, USP and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose,low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide, talc, and (5 mg only) ferric oxide yellow."
},
{
"NDCCode": "59746-463-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59746-463-30) ",
"NDC11Code": "59746-0463-30",
"ProductNDC": "59746-463",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil",
"NonProprietaryName": "Olmesartan Medoxomil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205482",
"LabelerName": "Jubilant Cadista Pharmacuticals Inc.",
"SubstanceName": "OLMESARTAN MEDOXOMIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170424",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Olmesartan medoxomil, USP a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil, USP is described chemically as 4-(1-Hydroxy-1-methylethyl)-2 propyl-1-[2-(1H-5- tetrazolyl) biphenyl-4-ylmethyl] imidazole-5-carboxylic acid 5-methyl-2-oxo-1,3-dioxol-4- ylmethyl ester. Its empirical formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil, USP is a white to off-white powder with a molecular weight of 558.58. It is slightly soluble in acetone, methanol; very slightly soluble in ethanol; practically insoluble in water. Olmesartan medoxomil is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil, USP and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose,low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide, talc, and (5 mg only) ferric oxide yellow."
},
{
"NDCCode": "59746-010-32",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (59746-010-32) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "59746-0010-32",
"ProductNDC": "59746-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20111104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090839",
"LabelerName": "Jubilant Cadista Pharmacuticals Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111104",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone orally disintegrating tablets are atypical antipsychotic indicated for: : 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3) .",
"Description": "Risperidone, USP is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is:. Risperidone, USP is a white to almost white powder. It is soluble in methylene chloride, sparingly soluble in alcohol and practically insoluble in water. Risperidone Orally Disintegrating Tablets, USP are available in 0.5 mg (yellow), 1 mg (white), 2 mg (blue), 3 mg (orange), and 4 mg (pink) strengths. Risperidone Orally Disintegrating Tablets, USP contain the following inactive ingredients: acesulfame potassium, amino methacrylate copolymer, aspartame, colloidal silicon dioxide, low substituted hydroxypropyl cellulose, magnesium aluminometasilicate, mannitol, peppermint flavor, sodium chloride, sodium lauryl sulfate, sodium stearyl fumarate and talc. In addition, 0.5 mg strength contains ferric oxide yellow, 2 mg strength contains FD&C Blue #1 Aluminum lake, 3 mg strength contains FD&C Yellow #6 Aluminum lake, and 4 mg strength contains ferric oxide red."
},
{
"NDCCode": "59746-020-32",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (59746-020-32) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "59746-0020-32",
"ProductNDC": "59746-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20111104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090839",
"LabelerName": "Jubilant Cadista Pharmacuticals Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111104",
"SamplePackage": "N",
"IndicationAndUsage": "Risperidone orally disintegrating tablets are atypical antipsychotic indicated for: : 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3) .",
"Description": "Risperidone, USP is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is:. Risperidone, USP is a white to almost white powder. It is soluble in methylene chloride, sparingly soluble in alcohol and practically insoluble in water. Risperidone Orally Disintegrating Tablets, USP are available in 0.5 mg (yellow), 1 mg (white), 2 mg (blue), 3 mg (orange), and 4 mg (pink) strengths. Risperidone Orally Disintegrating Tablets, USP contain the following inactive ingredients: acesulfame potassium, amino methacrylate copolymer, aspartame, colloidal silicon dioxide, low substituted hydroxypropyl cellulose, magnesium aluminometasilicate, mannitol, peppermint flavor, sodium chloride, sodium lauryl sulfate, sodium stearyl fumarate and talc. In addition, 0.5 mg strength contains ferric oxide yellow, 2 mg strength contains FD&C Blue #1 Aluminum lake, 3 mg strength contains FD&C Yellow #6 Aluminum lake, and 4 mg strength contains ferric oxide red."
},
{
"NDCCode": "59746-285-32",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (59746-285-32) > 10 TABLET, CHEWABLE in 1 BLISTER PACK",
"NDC11Code": "59746-0285-32",
"ProductNDC": "59746-285",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20150219",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091116",
"LabelerName": "Jubilant Cadista Pharmaceuticals Inc.",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150219",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: : 1 runny nose , 2 itchy, watery eyes , 3 sneezing , 4 itching of the nose or throat."
},
{
"NDCCode": "59746-286-32",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (59746-286-32) > 10 TABLET, CHEWABLE in 1 BLISTER PACK",
"NDC11Code": "59746-0286-32",
"ProductNDC": "59746-286",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20150219",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091116",
"LabelerName": "Jubilant Cadista Pharmaceuticals Inc.",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150219",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: : 1 runny nose , 2 itchy, watery eyes , 3 sneezing , 4 itching of the nose or throat."
},
{
"NDCCode": "59746-306-32",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (59746-306-32) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59746-306-12) ",
"NDC11Code": "59746-0306-32",
"ProductNDC": "59746-306",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20120913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200221",
"LabelerName": "Jubilant Cadista Pharmacuticals Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120913",
"SamplePackage": "N",
"Description": "Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine, USP is a yellow crystalline solid, which is soluble in n-propanol; sparingly soluble in acetonitrile; slightly soluble in methanol and in dehydrated alcohol; practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine, USP equivalent to 5 mg, 10 mg, 15 mg or 20 mg. It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, low-substituted hydroxyl propyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose and strawberry flavor 52311 AP 0551 which contains artificial flavors, benzyl alcohol, maltodextrin, propylene glycol and triethyl citrate. Olanzapine orally disintegrating tablets meets USP Disintegration Test 2."
},
{
"NDCCode": "59746-307-32",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (59746-307-32) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59746-307-12) ",
"NDC11Code": "59746-0307-32",
"ProductNDC": "59746-307",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20120913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200221",
"LabelerName": "Jubilant Cadista Pharmacuticals Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120913",
"SamplePackage": "N",
"Description": "Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine, USP is a yellow crystalline solid, which is soluble in n-propanol; sparingly soluble in acetonitrile; slightly soluble in methanol and in dehydrated alcohol; practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine, USP equivalent to 5 mg, 10 mg, 15 mg or 20 mg. It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, low-substituted hydroxyl propyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose and strawberry flavor 52311 AP 0551 which contains artificial flavors, benzyl alcohol, maltodextrin, propylene glycol and triethyl citrate. Olanzapine orally disintegrating tablets meets USP Disintegration Test 2."
},
{
"NDCCode": "59746-308-32",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (59746-308-32) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59746-308-12) ",
"NDC11Code": "59746-0308-32",
"ProductNDC": "59746-308",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20120913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200221",
"LabelerName": "Jubilant Cadista Pharmacuticals Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120913",
"SamplePackage": "N",
"Description": "Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine, USP is a yellow crystalline solid, which is soluble in n-propanol; sparingly soluble in acetonitrile; slightly soluble in methanol and in dehydrated alcohol; practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine, USP equivalent to 5 mg, 10 mg, 15 mg or 20 mg. It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, low-substituted hydroxyl propyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose and strawberry flavor 52311 AP 0551 which contains artificial flavors, benzyl alcohol, maltodextrin, propylene glycol and triethyl citrate. Olanzapine orally disintegrating tablets meets USP Disintegration Test 2."
},
{
"NDCCode": "59746-309-32",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (59746-309-32) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59746-309-12) ",
"NDC11Code": "59746-0309-32",
"ProductNDC": "59746-309",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20120913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200221",
"LabelerName": "Jubilant Cadista Pharmacuticals Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120913",
"SamplePackage": "N",
"Description": "Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine, USP is a yellow crystalline solid, which is soluble in n-propanol; sparingly soluble in acetonitrile; slightly soluble in methanol and in dehydrated alcohol; practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine, USP equivalent to 5 mg, 10 mg, 15 mg or 20 mg. It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, low-substituted hydroxyl propyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose and strawberry flavor 52311 AP 0551 which contains artificial flavors, benzyl alcohol, maltodextrin, propylene glycol and triethyl citrate. Olanzapine orally disintegrating tablets meets USP Disintegration Test 2."
},
{
"NDCCode": "59746-358-32",
"PackageDescription": "3 TABLET, CHEWABLE in 1 CARTON (59746-358-32) ",
"NDC11Code": "59746-0358-32",
"ProductNDC": "59746-358",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Montelukast Sodium Chewable",
"NonProprietaryName": "Montelukast Sodium",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20150228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203795",
"LabelerName": "Jubilant Cadista Pharmaceuticals Inc.",
"SubstanceName": "MONTELUKAST SODIUM",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20150228",
"SamplePackage": "N"
},
{
"NDCCode": "59746-359-32",
"PackageDescription": "3 TABLET, CHEWABLE in 1 CARTON (59746-359-32) ",
"NDC11Code": "59746-0359-32",
"ProductNDC": "59746-359",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Montelukast Sodium Chewable",
"NonProprietaryName": "Montelukast Sodium",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20150228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203795",
"LabelerName": "Jubilant Cadista Pharmaceuticals Inc.",
"SubstanceName": "MONTELUKAST SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20150228",
"SamplePackage": "N"
},
{
"NDCCode": "59746-363-32",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (59746-363-32) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "59746-0363-32",
"ProductNDC": "59746-363",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203536",
"LabelerName": "Jubilant Cadista Pharmacuticals Inc.",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "320",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150105",
"SamplePackage": "N",
"IndicationAndUsage": "Valsartan tablets are angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2), 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults(1.3).",
"Description": "Valsartan USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.52, and its structural formula is. Valsartan USP is a white to off white hygroscopic powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg and 320 mg of valsartan USP. The inactive ingredients of the tablets are anhydrous lactose, crospovidone, dental-type silica, ferric oxide red (80 mg only), ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "59746-393-32",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (59746-393-32) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "59746-0393-32",
"ProductNDC": "59746-393",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valsartan",
"NonProprietaryName": "Valsartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260824",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203536",
"LabelerName": "Jubilant Cadista Pharmaceuticals Inc.",
"SubstanceName": "VALSARTAN",
"StrengthNumber": "320",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260824",
"SamplePackage": "N",
"IndicationAndUsage": "Valsartan tablets are angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2), 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).",
"Description": "Valsartan USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.52, and its structural formula is. Valsartan, USP is a white to off white hygroscopic powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available for oral administration, containing 40 mg, 80 mg, 160 mg and 320 mg of valsartan USP. The inactive ingredients of the tablets are anhydrous lactose, crospovidone, dental-type silica, ferric oxide red (80 mg only), ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "59746-439-32",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (59746-439-32) / 10 TABLET in 1 BLISTER PACK (59746-439-12) ",
"NDC11Code": "59746-0439-32",
"ProductNDC": "59746-439",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Telmisartan",
"NonProprietaryName": "Telmisartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204164",
"LabelerName": "Jubilant Cadista Pharmacuticals Inc.",
"SubstanceName": "TELMISARTAN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160822",
"SamplePackage": "N",
"IndicationAndUsage": "Telmisartan tablets, USP are angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).",
"Description": "Telmisartan, USP is a non-peptide angiotensin II receptor (type AT1) antagonist. Telmisartan is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its molecular formula is C33H30N4O2, its molecular weight is 514.62, and its structural formula is:. Telmisartan, USP is a white to slightly yellowish, crystalline powder. It is practically insoluble in water, sparingly soluble in methylene chloride. It dissolves in 1M sodium hydroxide. Telmisartan, USP is available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan. The tablets contain the following inactive ingredients: magnesium stearate, mannitol, meglumine, povidone and sodium hydroxide. Telmisartan tablets, USP are hygroscopic and require protection from moisture."
},
{
"NDCCode": "59746-440-32",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (59746-440-32) / 10 TABLET in 1 BLISTER PACK (59746-440-12) ",
"NDC11Code": "59746-0440-32",
"ProductNDC": "59746-440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Telmisartan",
"NonProprietaryName": "Telmisartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204164",
"LabelerName": "Jubilant Cadista Pharmacuticals Inc.",
"SubstanceName": "TELMISARTAN",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160822",
"SamplePackage": "N",
"IndicationAndUsage": "Telmisartan tablets, USP are angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).",
"Description": "Telmisartan, USP is a non-peptide angiotensin II receptor (type AT1) antagonist. Telmisartan is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its molecular formula is C33H30N4O2, its molecular weight is 514.62, and its structural formula is:. Telmisartan, USP is a white to slightly yellowish, crystalline powder. It is practically insoluble in water, sparingly soluble in methylene chloride. It dissolves in 1M sodium hydroxide. Telmisartan, USP is available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan. The tablets contain the following inactive ingredients: magnesium stearate, mannitol, meglumine, povidone and sodium hydroxide. Telmisartan tablets, USP are hygroscopic and require protection from moisture."
},
{
"NDCCode": "59746-441-32",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (59746-441-32) / 10 TABLET in 1 BLISTER PACK (59746-441-12) ",
"NDC11Code": "59746-0441-32",
"ProductNDC": "59746-441",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Telmisartan",
"NonProprietaryName": "Telmisartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204164",
"LabelerName": "Jubilant Cadista Pharmacuticals Inc.",
"SubstanceName": "TELMISARTAN",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160822",
"SamplePackage": "N",
"IndicationAndUsage": "Telmisartan tablets, USP are angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).",
"Description": "Telmisartan, USP is a non-peptide angiotensin II receptor (type AT1) antagonist. Telmisartan is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its molecular formula is C33H30N4O2, its molecular weight is 514.62, and its structural formula is:. Telmisartan, USP is a white to slightly yellowish, crystalline powder. It is practically insoluble in water, sparingly soluble in methylene chloride. It dissolves in 1M sodium hydroxide. Telmisartan, USP is available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan. The tablets contain the following inactive ingredients: magnesium stearate, mannitol, meglumine, povidone and sodium hydroxide. Telmisartan tablets, USP are hygroscopic and require protection from moisture."
},
{
"NDCCode": "59746-465-32",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (59746-465-32) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "59746-0465-32",
"ProductNDC": "59746-465",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil",
"NonProprietaryName": "Olmesartan Medoxomil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205482",
"LabelerName": "Jubilant Cadista Pharmacuticals Inc.",
"SubstanceName": "OLMESARTAN MEDOXOMIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170424",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Olmesartan medoxomil, USP a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil, USP is described chemically as 4-(1-Hydroxy-1-methylethyl)-2 propyl-1-[2-(1H-5- tetrazolyl) biphenyl-4-ylmethyl] imidazole-5-carboxylic acid 5-methyl-2-oxo-1,3-dioxol-4- ylmethyl ester. Its empirical formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil, USP is a white to off-white powder with a molecular weight of 558.58. It is slightly soluble in acetone, methanol; very slightly soluble in ethanol; practically insoluble in water. Olmesartan medoxomil is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil, USP and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose,low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide, talc, and (5 mg only) ferric oxide yellow."
},
{
"NDCCode": "59746-466-32",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (59746-466-32) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "59746-0466-32",
"ProductNDC": "59746-466",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil",
"NonProprietaryName": "Olmesartan Medoxomil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205482",
"LabelerName": "Jubilant Cadista Pharmacuticals Inc.",
"SubstanceName": "OLMESARTAN MEDOXOMIL",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170424",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Olmesartan medoxomil, USP a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil, USP is described chemically as 4-(1-Hydroxy-1-methylethyl)-2 propyl-1-[2-(1H-5- tetrazolyl) biphenyl-4-ylmethyl] imidazole-5-carboxylic acid 5-methyl-2-oxo-1,3-dioxol-4- ylmethyl ester. Its empirical formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil, USP is a white to off-white powder with a molecular weight of 558.58. It is slightly soluble in acetone, methanol; very slightly soluble in ethanol; practically insoluble in water. Olmesartan medoxomil is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil, USP and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose,low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide, talc, and (5 mg only) ferric oxide yellow."
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"ProprietaryName": "Eletriptan Hydrobromide",
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"ApplicationNumber": "ANDA205152",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ELETRIPTAN HYDROBROMIDE",
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"IndicationAndUsage": "Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: : 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with eletriptan hydrobromide tablets, reconsider the diagnosis of migraine before eletriptan hydrobromide tablets are administered to treat any subsequent attacks., 2 Eletriptan hydrobromide tablets are not intended for the prevention of migraine attacks., 3 Safety and effectiveness of eletriptan hydrobromide tablets have not been established for cluster headache.",
"Description": "Eletriptan hydrobromide tablets contain eletriptan hydrobromide, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Eletriptan hydrobromide is chemically designated as (R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole monohydrobromide, and it has the following chemical structure. The molecular formula is C22H26N2O2S HBr, representing a molecular weight of 463.43. Eletriptan hydrobromide is an off-white to light brown colored powder that is readily soluble in water. Each eletriptan hydrobromide tablet for oral administration contains 24.231 or 48.462 mg of eletriptan hydrobromide equivalent to 20 mg or 40 mg of eletriptan, respectively. Each tablet also contains the inactive ingredients anhydrous lactose, croscarmellose sodium, FD&C Yellow No. 6 Aluminum Lake, lecithin, microcrystalline cellulose, magnesium stearate, polyvinyl alcohol, talc, titanium dioxide and xanthan gum."
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"LabelerName": "Mylan Pharmaceuticals Inc.",
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"IndicationAndUsage": "Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: : 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with eletriptan hydrobromide tablets, reconsider the diagnosis of migraine before eletriptan hydrobromide tablets are administered to treat any subsequent attacks., 2 Eletriptan hydrobromide tablets are not intended for the prevention of migraine attacks., 3 Safety and effectiveness of eletriptan hydrobromide tablets have not been established for cluster headache.",
"Description": "Eletriptan hydrobromide tablets contain eletriptan hydrobromide, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Eletriptan hydrobromide is chemically designated as (R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole monohydrobromide, and it has the following chemical structure. The molecular formula is C22H26N2O2S HBr, representing a molecular weight of 463.43. Eletriptan hydrobromide is an off-white to light brown colored powder that is readily soluble in water. Each eletriptan hydrobromide tablet for oral administration contains 24.231 or 48.462 mg of eletriptan hydrobromide equivalent to 20 mg or 40 mg of eletriptan, respectively. Each tablet also contains the inactive ingredients anhydrous lactose, croscarmellose sodium, FD&C Yellow No. 6 Aluminum Lake, lecithin, microcrystalline cellulose, magnesium stearate, polyvinyl alcohol, talc, titanium dioxide and xanthan gum."
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"IndicationAndUsage": "Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: : 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with eletriptan hydrobromide tablets, reconsider the diagnosis of migraine before eletriptan hydrobromide tablets are administered to treat any subsequent attacks., 2 Eletriptan hydrobromide tablets are not intended for the prevention of migraine attacks., 3 Safety and effectiveness of eletriptan hydrobromide tablets have not been established for cluster headache.",
"Description": "Eletriptan hydrobromide tablets contain eletriptan hydrobromide, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Eletriptan hydrobromide is chemically designated as (R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole monohydrobromide, and it has the following chemical structure. The molecular formula is C22H26N2O2S HBr, representing a molecular weight of 463.43. Eletriptan hydrobromide is an off-white to light brown colored powder that is readily soluble in water. Each eletriptan hydrobromide tablet for oral administration contains 24.231 or 48.462 mg of eletriptan hydrobromide equivalent to 20 mg or 40 mg of eletriptan, respectively. Each tablet also contains the inactive ingredients anhydrous lactose, croscarmellose sodium, FD&C Yellow No. 6 Aluminum Lake, lecithin, microcrystalline cellulose, magnesium stearate, polyvinyl alcohol, talc, titanium dioxide and xanthan gum."
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"IndicationAndUsage": "Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with eletriptan hydrobromide tablets, reconsider the diagnosis of migraine before eletriptan hydrobromide tablets are administered to treat any subsequent attacks. Eletriptan hydrobromide tablets are not intended for the prevention of migraine attacks. Safety and effectiveness of eletriptan hydrobromide tablets have not been established for cluster headache.",
"Description": "Eletriptan hydrobromide tablets contain eletriptan hydrobromide, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Eletriptan hydrobromide is chemically designated as (R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole monohydrobromide, and it has the following chemical structure. The molecular formula is C 22H 26N 2O 2S.HBr, representing a molecular weight of 463.43. Eletriptan hydrobromide is a cream to pale brown powder that is freely soluble in dimethylsulfoxide and sparingly soluble in methanol. Each eletriptan hydrobromide tablet for oral administration contains 24.230 or 48.461 mg of eletriptan hydrobromide equivalent to 20 mg or 40 mg of eletriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, FD&C yellow #6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin."
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{
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"IndicationAndUsage": "Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with eletriptan hydrobromide tablets, reconsider the diagnosis of migraine before eletriptan hydrobromide tablets are administered to treat any subsequent attacks. Eletriptan hydrobromide tablets are not intended for the prevention of migraine attacks. Safety and effectiveness of eletriptan hydrobromide tablets have not been established for cluster headache.",
"Description": "Eletriptan hydrobromide tablets contain eletriptan hydrobromide, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Eletriptan hydrobromide is chemically designated as (R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole monohydrobromide, and it has the following chemical structure. The molecular formula is C 22H 26N 2O 2S.HBr, representing a molecular weight of 463.43. Eletriptan hydrobromide is a cream to pale brown powder that is freely soluble in dimethylsulfoxide and sparingly soluble in methanol. Each eletriptan hydrobromide tablet for oral administration contains 24.230 or 48.461 mg of eletriptan hydrobromide equivalent to 20 mg or 40 mg of eletriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, FD&C yellow #6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin."
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"IndicationAndUsage": "Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with eletriptan hydrobromide tablets, reconsider the diagnosis of migraine before eletriptan hydrobromide tablets are administered to treat any subsequent attacks. Eletriptan hydrobromide tablets are not intended for the prevention of migraine attacks. Safety and effectiveness of eletriptan hydrobromide tablets have not been established for cluster headache.",
"Description": "Eletriptan hydrobromide tablets contain eletriptan hydrobromide, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Eletriptan hydrobromide is chemically designated as (R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole monohydrobromide, and it has the following chemical structure. The molecular formula is C 22H 26N 2O 2S.HBr, representing a molecular weight of 463.43. Eletriptan hydrobromide is a cream to pale brown powder that is freely soluble in dimethylsulfoxide and sparingly soluble in methanol. Each eletriptan hydrobromide tablet for oral administration contains 24.230 or 48.461 mg of eletriptan hydrobromide equivalent to 20 mg or 40 mg of eletriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, FD&C yellow #6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin."
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<IndicationAndUsage>Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Olmesartan medoxomil, USP a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil, USP is described chemically as 4-(1-Hydroxy-1-methylethyl)-2 propyl-1-[2-(1H-5- tetrazolyl) biphenyl-4-ylmethyl] imidazole-5-carboxylic acid 5-methyl-2-oxo-1,3-dioxol-4- ylmethyl ester. Its empirical formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil, USP is a white to off-white powder with a molecular weight of 558.58. It is slightly soluble in acetone, methanol; very slightly soluble in ethanol; practically insoluble in water. Olmesartan medoxomil is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil, USP and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose,low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide, talc, and (5 mg only) ferric oxide yellow.</Description>
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<IndicationAndUsage>surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care. healthcare personnel handwash: handwash to help reduce bacteria that potentially can cause disease.</IndicationAndUsage>
</NDC>
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<NDCCode>59746-463-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59746-463-01) </PackageDescription>
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<ProductNDC>59746-463</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205482</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Olmesartan medoxomil, USP a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil, USP is described chemically as 4-(1-Hydroxy-1-methylethyl)-2 propyl-1-[2-(1H-5- tetrazolyl) biphenyl-4-ylmethyl] imidazole-5-carboxylic acid 5-methyl-2-oxo-1,3-dioxol-4- ylmethyl ester. Its empirical formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil, USP is a white to off-white powder with a molecular weight of 558.58. It is slightly soluble in acetone, methanol; very slightly soluble in ethanol; practically insoluble in water. Olmesartan medoxomil is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil, USP and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose,low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide, talc, and (5 mg only) ferric oxide yellow.</Description>
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<NDCCode>59746-463-10</NDCCode>
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<NDC11Code>59746-0463-10</NDC11Code>
<ProductNDC>59746-463</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
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<StartMarketingDate>20160401</StartMarketingDate>
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<LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Olmesartan medoxomil, USP a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil, USP is described chemically as 4-(1-Hydroxy-1-methylethyl)-2 propyl-1-[2-(1H-5- tetrazolyl) biphenyl-4-ylmethyl] imidazole-5-carboxylic acid 5-methyl-2-oxo-1,3-dioxol-4- ylmethyl ester. Its empirical formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil, USP is a white to off-white powder with a molecular weight of 558.58. It is slightly soluble in acetone, methanol; very slightly soluble in ethanol; practically insoluble in water. Olmesartan medoxomil is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil, USP and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose,low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide, talc, and (5 mg only) ferric oxide yellow.</Description>
</NDC>
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<NDCCode>59746-463-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59746-463-30) </PackageDescription>
<NDC11Code>59746-0463-30</NDC11Code>
<ProductNDC>59746-463</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205482</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Olmesartan medoxomil, USP a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil, USP is described chemically as 4-(1-Hydroxy-1-methylethyl)-2 propyl-1-[2-(1H-5- tetrazolyl) biphenyl-4-ylmethyl] imidazole-5-carboxylic acid 5-methyl-2-oxo-1,3-dioxol-4- ylmethyl ester. Its empirical formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil, USP is a white to off-white powder with a molecular weight of 558.58. It is slightly soluble in acetone, methanol; very slightly soluble in ethanol; practically insoluble in water. Olmesartan medoxomil is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil, USP and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose,low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide, talc, and (5 mg only) ferric oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>59746-010-32</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (59746-010-32) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59746-0010-32</NDC11Code>
<ProductNDC>59746-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090839</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone orally disintegrating tablets are atypical antipsychotic indicated for: : 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3) .</IndicationAndUsage>
<Description>Risperidone, USP is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is:. Risperidone, USP is a white to almost white powder. It is soluble in methylene chloride, sparingly soluble in alcohol and practically insoluble in water. Risperidone Orally Disintegrating Tablets, USP are available in 0.5 mg (yellow), 1 mg (white), 2 mg (blue), 3 mg (orange), and 4 mg (pink) strengths. Risperidone Orally Disintegrating Tablets, USP contain the following inactive ingredients: acesulfame potassium, amino methacrylate copolymer, aspartame, colloidal silicon dioxide, low substituted hydroxypropyl cellulose, magnesium aluminometasilicate, mannitol, peppermint flavor, sodium chloride, sodium lauryl sulfate, sodium stearyl fumarate and talc. In addition, 0.5 mg strength contains ferric oxide yellow, 2 mg strength contains FD&C Blue #1 Aluminum lake, 3 mg strength contains FD&C Yellow #6 Aluminum lake, and 4 mg strength contains ferric oxide red.</Description>
</NDC>
<NDC>
<NDCCode>59746-020-32</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (59746-020-32) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59746-0020-32</NDC11Code>
<ProductNDC>59746-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090839</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Risperidone orally disintegrating tablets are atypical antipsychotic indicated for: : 1 Treatment of schizophrenia (1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3) .</IndicationAndUsage>
<Description>Risperidone, USP is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is:. Risperidone, USP is a white to almost white powder. It is soluble in methylene chloride, sparingly soluble in alcohol and practically insoluble in water. Risperidone Orally Disintegrating Tablets, USP are available in 0.5 mg (yellow), 1 mg (white), 2 mg (blue), 3 mg (orange), and 4 mg (pink) strengths. Risperidone Orally Disintegrating Tablets, USP contain the following inactive ingredients: acesulfame potassium, amino methacrylate copolymer, aspartame, colloidal silicon dioxide, low substituted hydroxypropyl cellulose, magnesium aluminometasilicate, mannitol, peppermint flavor, sodium chloride, sodium lauryl sulfate, sodium stearyl fumarate and talc. In addition, 0.5 mg strength contains ferric oxide yellow, 2 mg strength contains FD&C Blue #1 Aluminum lake, 3 mg strength contains FD&C Yellow #6 Aluminum lake, and 4 mg strength contains ferric oxide red.</Description>
</NDC>
<NDC>
<NDCCode>59746-285-32</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (59746-285-32) > 10 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59746-0285-32</NDC11Code>
<ProductNDC>59746-285</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150219</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091116</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: : 1 runny nose , 2 itchy, watery eyes , 3 sneezing , 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59746-286-32</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (59746-286-32) > 10 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59746-0286-32</NDC11Code>
<ProductNDC>59746-286</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150219</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091116</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: : 1 runny nose , 2 itchy, watery eyes , 3 sneezing , 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59746-306-32</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (59746-306-32) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59746-306-12) </PackageDescription>
<NDC11Code>59746-0306-32</NDC11Code>
<ProductNDC>59746-306</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200221</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine, USP is a yellow crystalline solid, which is soluble in n-propanol; sparingly soluble in acetonitrile; slightly soluble in methanol and in dehydrated alcohol; practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine, USP equivalent to 5 mg, 10 mg, 15 mg or 20 mg. It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, low-substituted hydroxyl propyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose and strawberry flavor 52311 AP 0551 which contains artificial flavors, benzyl alcohol, maltodextrin, propylene glycol and triethyl citrate. Olanzapine orally disintegrating tablets meets USP Disintegration Test 2.</Description>
</NDC>
<NDC>
<NDCCode>59746-307-32</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (59746-307-32) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59746-307-12) </PackageDescription>
<NDC11Code>59746-0307-32</NDC11Code>
<ProductNDC>59746-307</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200221</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine, USP is a yellow crystalline solid, which is soluble in n-propanol; sparingly soluble in acetonitrile; slightly soluble in methanol and in dehydrated alcohol; practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine, USP equivalent to 5 mg, 10 mg, 15 mg or 20 mg. It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, low-substituted hydroxyl propyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose and strawberry flavor 52311 AP 0551 which contains artificial flavors, benzyl alcohol, maltodextrin, propylene glycol and triethyl citrate. Olanzapine orally disintegrating tablets meets USP Disintegration Test 2.</Description>
</NDC>
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<NDCCode>59746-308-32</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (59746-308-32) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59746-308-12) </PackageDescription>
<NDC11Code>59746-0308-32</NDC11Code>
<ProductNDC>59746-308</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200221</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine, USP is a yellow crystalline solid, which is soluble in n-propanol; sparingly soluble in acetonitrile; slightly soluble in methanol and in dehydrated alcohol; practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine, USP equivalent to 5 mg, 10 mg, 15 mg or 20 mg. It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, low-substituted hydroxyl propyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose and strawberry flavor 52311 AP 0551 which contains artificial flavors, benzyl alcohol, maltodextrin, propylene glycol and triethyl citrate. Olanzapine orally disintegrating tablets meets USP Disintegration Test 2.</Description>
</NDC>
<NDC>
<NDCCode>59746-309-32</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (59746-309-32) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59746-309-12) </PackageDescription>
<NDC11Code>59746-0309-32</NDC11Code>
<ProductNDC>59746-309</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200221</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine, USP is a yellow crystalline solid, which is soluble in n-propanol; sparingly soluble in acetonitrile; slightly soluble in methanol and in dehydrated alcohol; practically insoluble in water. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine, USP equivalent to 5 mg, 10 mg, 15 mg or 20 mg. It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, low-substituted hydroxyl propyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose and strawberry flavor 52311 AP 0551 which contains artificial flavors, benzyl alcohol, maltodextrin, propylene glycol and triethyl citrate. Olanzapine orally disintegrating tablets meets USP Disintegration Test 2.</Description>
</NDC>
<NDC>
<NDCCode>59746-358-32</NDCCode>
<PackageDescription>3 TABLET, CHEWABLE in 1 CARTON (59746-358-32) </PackageDescription>
<NDC11Code>59746-0358-32</NDC11Code>
<ProductNDC>59746-358</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Montelukast Sodium Chewable</ProprietaryName>
<NonProprietaryName>Montelukast Sodium</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203795</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
<SubstanceName>MONTELUKAST SODIUM</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>59746-359-32</NDCCode>
<PackageDescription>3 TABLET, CHEWABLE in 1 CARTON (59746-359-32) </PackageDescription>
<NDC11Code>59746-0359-32</NDC11Code>
<ProductNDC>59746-359</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Montelukast Sodium Chewable</ProprietaryName>
<NonProprietaryName>Montelukast Sodium</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203795</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
<SubstanceName>MONTELUKAST SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59746-363-32</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (59746-363-32) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59746-0363-32</NDC11Code>
<ProductNDC>59746-363</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203536</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>320</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valsartan tablets are angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2), 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults(1.3).</IndicationAndUsage>
<Description>Valsartan USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.52, and its structural formula is. Valsartan USP is a white to off white hygroscopic powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg and 320 mg of valsartan USP. The inactive ingredients of the tablets are anhydrous lactose, crospovidone, dental-type silica, ferric oxide red (80 mg only), ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>59746-393-32</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (59746-393-32) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59746-0393-32</NDC11Code>
<ProductNDC>59746-393</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valsartan</ProprietaryName>
<NonProprietaryName>Valsartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260824</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203536</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
<SubstanceName>VALSARTAN</SubstanceName>
<StrengthNumber>320</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valsartan tablets are angiotensin II receptor blocker (ARB) indicated for: 1 Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1), 2 Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults (1.2), 3 Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3).</IndicationAndUsage>
<Description>Valsartan USP is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.52, and its structural formula is. Valsartan, USP is a white to off white hygroscopic powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available for oral administration, containing 40 mg, 80 mg, 160 mg and 320 mg of valsartan USP. The inactive ingredients of the tablets are anhydrous lactose, crospovidone, dental-type silica, ferric oxide red (80 mg only), ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>59746-439-32</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (59746-439-32) / 10 TABLET in 1 BLISTER PACK (59746-439-12) </PackageDescription>
<NDC11Code>59746-0439-32</NDC11Code>
<ProductNDC>59746-439</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Telmisartan</ProprietaryName>
<NonProprietaryName>Telmisartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204164</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
<SubstanceName>TELMISARTAN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Telmisartan tablets, USP are angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
<Description>Telmisartan, USP is a non-peptide angiotensin II receptor (type AT1) antagonist. Telmisartan is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its molecular formula is C33H30N4O2, its molecular weight is 514.62, and its structural formula is:. Telmisartan, USP is a white to slightly yellowish, crystalline powder. It is practically insoluble in water, sparingly soluble in methylene chloride. It dissolves in 1M sodium hydroxide. Telmisartan, USP is available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan. The tablets contain the following inactive ingredients: magnesium stearate, mannitol, meglumine, povidone and sodium hydroxide. Telmisartan tablets, USP are hygroscopic and require protection from moisture.</Description>
</NDC>
<NDC>
<NDCCode>59746-440-32</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (59746-440-32) / 10 TABLET in 1 BLISTER PACK (59746-440-12) </PackageDescription>
<NDC11Code>59746-0440-32</NDC11Code>
<ProductNDC>59746-440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Telmisartan</ProprietaryName>
<NonProprietaryName>Telmisartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204164</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
<SubstanceName>TELMISARTAN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Telmisartan tablets, USP are angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
<Description>Telmisartan, USP is a non-peptide angiotensin II receptor (type AT1) antagonist. Telmisartan is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its molecular formula is C33H30N4O2, its molecular weight is 514.62, and its structural formula is:. Telmisartan, USP is a white to slightly yellowish, crystalline powder. It is practically insoluble in water, sparingly soluble in methylene chloride. It dissolves in 1M sodium hydroxide. Telmisartan, USP is available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan. The tablets contain the following inactive ingredients: magnesium stearate, mannitol, meglumine, povidone and sodium hydroxide. Telmisartan tablets, USP are hygroscopic and require protection from moisture.</Description>
</NDC>
<NDC>
<NDCCode>59746-441-32</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (59746-441-32) / 10 TABLET in 1 BLISTER PACK (59746-441-12) </PackageDescription>
<NDC11Code>59746-0441-32</NDC11Code>
<ProductNDC>59746-441</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Telmisartan</ProprietaryName>
<NonProprietaryName>Telmisartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204164</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
<SubstanceName>TELMISARTAN</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Telmisartan tablets, USP are angiotensin II receptor blocker (ARB) indicated for: 1 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
<Description>Telmisartan, USP is a non-peptide angiotensin II receptor (type AT1) antagonist. Telmisartan is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its molecular formula is C33H30N4O2, its molecular weight is 514.62, and its structural formula is:. Telmisartan, USP is a white to slightly yellowish, crystalline powder. It is practically insoluble in water, sparingly soluble in methylene chloride. It dissolves in 1M sodium hydroxide. Telmisartan, USP is available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan. The tablets contain the following inactive ingredients: magnesium stearate, mannitol, meglumine, povidone and sodium hydroxide. Telmisartan tablets, USP are hygroscopic and require protection from moisture.</Description>
</NDC>
<NDC>
<NDCCode>59746-465-32</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (59746-465-32) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59746-0465-32</NDC11Code>
<ProductNDC>59746-465</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205482</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Olmesartan medoxomil, USP a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil, USP is described chemically as 4-(1-Hydroxy-1-methylethyl)-2 propyl-1-[2-(1H-5- tetrazolyl) biphenyl-4-ylmethyl] imidazole-5-carboxylic acid 5-methyl-2-oxo-1,3-dioxol-4- ylmethyl ester. Its empirical formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil, USP is a white to off-white powder with a molecular weight of 558.58. It is slightly soluble in acetone, methanol; very slightly soluble in ethanol; practically insoluble in water. Olmesartan medoxomil is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil, USP and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose,low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide, talc, and (5 mg only) ferric oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>59746-466-32</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (59746-466-32) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59746-0466-32</NDC11Code>
<ProductNDC>59746-466</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205482</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmacuticals Inc.</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Olmesartan medoxomil, USP a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil, USP is described chemically as 4-(1-Hydroxy-1-methylethyl)-2 propyl-1-[2-(1H-5- tetrazolyl) biphenyl-4-ylmethyl] imidazole-5-carboxylic acid 5-methyl-2-oxo-1,3-dioxol-4- ylmethyl ester. Its empirical formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil, USP is a white to off-white powder with a molecular weight of 558.58. It is slightly soluble in acetone, methanol; very slightly soluble in ethanol; practically insoluble in water. Olmesartan medoxomil is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil, USP and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose,low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide, talc, and (5 mg only) ferric oxide yellow.</Description>
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<PackageDescription>10 TABLET, FILM COATED in 1 BLISTER PACK (59746-513-32) </PackageDescription>
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<ProductNDC>59746-513</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203613</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDCCode>59746-514-32</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BLISTER PACK (59746-514-32) </PackageDescription>
<NDC11Code>59746-0514-32</NDC11Code>
<ProductNDC>59746-514</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203613</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>0378-4287-85</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (0378-4287-85) > 6 TABLET, FILM COATED in 1 BLISTER PACK (0378-4287-32) </PackageDescription>
<NDC11Code>00378-4287-85</NDC11Code>
<ProductNDC>0378-4287</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eletriptan Hydrobromide</ProprietaryName>
<NonProprietaryName>Eletriptan Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205152</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ELETRIPTAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: : 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with eletriptan hydrobromide tablets, reconsider the diagnosis of migraine before eletriptan hydrobromide tablets are administered to treat any subsequent attacks., 2 Eletriptan hydrobromide tablets are not intended for the prevention of migraine attacks., 3 Safety and effectiveness of eletriptan hydrobromide tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Eletriptan hydrobromide tablets contain eletriptan hydrobromide, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Eletriptan hydrobromide is chemically designated as (R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole monohydrobromide, and it has the following chemical structure. The molecular formula is C22H26N2O2S HBr, representing a molecular weight of 463.43. Eletriptan hydrobromide is an off-white to light brown colored powder that is readily soluble in water. Each eletriptan hydrobromide tablet for oral administration contains 24.231 or 48.462 mg of eletriptan hydrobromide equivalent to 20 mg or 40 mg of eletriptan, respectively. Each tablet also contains the inactive ingredients anhydrous lactose, croscarmellose sodium, FD&C Yellow No. 6 Aluminum Lake, lecithin, microcrystalline cellulose, magnesium stearate, polyvinyl alcohol, talc, titanium dioxide and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>0378-4288-08</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (0378-4288-08) > 6 TABLET, FILM COATED in 1 BLISTER PACK (0378-4288-32) </PackageDescription>
<NDC11Code>00378-4288-08</NDC11Code>
<ProductNDC>0378-4288</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eletriptan Hydrobromide</ProprietaryName>
<NonProprietaryName>Eletriptan Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205152</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ELETRIPTAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: : 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with eletriptan hydrobromide tablets, reconsider the diagnosis of migraine before eletriptan hydrobromide tablets are administered to treat any subsequent attacks., 2 Eletriptan hydrobromide tablets are not intended for the prevention of migraine attacks., 3 Safety and effectiveness of eletriptan hydrobromide tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Eletriptan hydrobromide tablets contain eletriptan hydrobromide, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Eletriptan hydrobromide is chemically designated as (R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole monohydrobromide, and it has the following chemical structure. The molecular formula is C22H26N2O2S HBr, representing a molecular weight of 463.43. Eletriptan hydrobromide is an off-white to light brown colored powder that is readily soluble in water. Each eletriptan hydrobromide tablet for oral administration contains 24.231 or 48.462 mg of eletriptan hydrobromide equivalent to 20 mg or 40 mg of eletriptan, respectively. Each tablet also contains the inactive ingredients anhydrous lactose, croscarmellose sodium, FD&C Yellow No. 6 Aluminum Lake, lecithin, microcrystalline cellulose, magnesium stearate, polyvinyl alcohol, talc, titanium dioxide and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>0378-4288-85</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (0378-4288-85) > 6 TABLET, FILM COATED in 1 BLISTER PACK (0378-4288-32) </PackageDescription>
<NDC11Code>00378-4288-85</NDC11Code>
<ProductNDC>0378-4288</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eletriptan Hydrobromide</ProprietaryName>
<NonProprietaryName>Eletriptan Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205152</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ELETRIPTAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: : 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with eletriptan hydrobromide tablets, reconsider the diagnosis of migraine before eletriptan hydrobromide tablets are administered to treat any subsequent attacks., 2 Eletriptan hydrobromide tablets are not intended for the prevention of migraine attacks., 3 Safety and effectiveness of eletriptan hydrobromide tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Eletriptan hydrobromide tablets contain eletriptan hydrobromide, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Eletriptan hydrobromide is chemically designated as (R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole monohydrobromide, and it has the following chemical structure. The molecular formula is C22H26N2O2S HBr, representing a molecular weight of 463.43. Eletriptan hydrobromide is an off-white to light brown colored powder that is readily soluble in water. Each eletriptan hydrobromide tablet for oral administration contains 24.231 or 48.462 mg of eletriptan hydrobromide equivalent to 20 mg or 40 mg of eletriptan, respectively. Each tablet also contains the inactive ingredients anhydrous lactose, croscarmellose sodium, FD&C Yellow No. 6 Aluminum Lake, lecithin, microcrystalline cellulose, magnesium stearate, polyvinyl alcohol, talc, titanium dioxide and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>31722-443-31</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (31722-443-31) / 6 TABLET, FILM COATED in 1 BLISTER PACK (31722-443-32) </PackageDescription>
<NDC11Code>31722-0443-31</NDC11Code>
<ProductNDC>31722-443</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eletriptan Hydrobromide</ProprietaryName>
<NonProprietaryName>Eletriptan Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250707</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219143</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ELETRIPTAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250707</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with eletriptan hydrobromide tablets, reconsider the diagnosis of migraine before eletriptan hydrobromide tablets are administered to treat any subsequent attacks. Eletriptan hydrobromide tablets are not intended for the prevention of migraine attacks. Safety and effectiveness of eletriptan hydrobromide tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Eletriptan hydrobromide tablets contain eletriptan hydrobromide, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Eletriptan hydrobromide is chemically designated as (R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole monohydrobromide, and it has the following chemical structure. The molecular formula is C 22H 26N 2O 2S.HBr, representing a molecular weight of 463.43. Eletriptan hydrobromide is a cream to pale brown powder that is freely soluble in dimethylsulfoxide and sparingly soluble in methanol. Each eletriptan hydrobromide tablet for oral administration contains 24.230 or 48.461 mg of eletriptan hydrobromide equivalent to 20 mg or 40 mg of eletriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, FD&C yellow #6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin.</Description>
</NDC>
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<NDCCode>31722-444-31</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (31722-444-31) / 6 TABLET, FILM COATED in 1 BLISTER PACK (31722-444-32) </PackageDescription>
<NDC11Code>31722-0444-31</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eletriptan Hydrobromide</ProprietaryName>
<NonProprietaryName>Eletriptan Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250707</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219143</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ELETRIPTAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250707</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with eletriptan hydrobromide tablets, reconsider the diagnosis of migraine before eletriptan hydrobromide tablets are administered to treat any subsequent attacks. Eletriptan hydrobromide tablets are not intended for the prevention of migraine attacks. Safety and effectiveness of eletriptan hydrobromide tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Eletriptan hydrobromide tablets contain eletriptan hydrobromide, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Eletriptan hydrobromide is chemically designated as (R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole monohydrobromide, and it has the following chemical structure. The molecular formula is C 22H 26N 2O 2S.HBr, representing a molecular weight of 463.43. Eletriptan hydrobromide is a cream to pale brown powder that is freely soluble in dimethylsulfoxide and sparingly soluble in methanol. Each eletriptan hydrobromide tablet for oral administration contains 24.230 or 48.461 mg of eletriptan hydrobromide equivalent to 20 mg or 40 mg of eletriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, FD&C yellow #6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin.</Description>
</NDC>
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<NDCCode>31722-444-33</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (31722-444-33) / 6 TABLET, FILM COATED in 1 BLISTER PACK (31722-444-32) </PackageDescription>
<NDC11Code>31722-0444-33</NDC11Code>
<ProductNDC>31722-444</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eletriptan Hydrobromide</ProprietaryName>
<NonProprietaryName>Eletriptan Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250707</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219143</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ELETRIPTAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250707</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with eletriptan hydrobromide tablets, reconsider the diagnosis of migraine before eletriptan hydrobromide tablets are administered to treat any subsequent attacks. Eletriptan hydrobromide tablets are not intended for the prevention of migraine attacks. Safety and effectiveness of eletriptan hydrobromide tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Eletriptan hydrobromide tablets contain eletriptan hydrobromide, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Eletriptan hydrobromide is chemically designated as (R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole monohydrobromide, and it has the following chemical structure. The molecular formula is C 22H 26N 2O 2S.HBr, representing a molecular weight of 463.43. Eletriptan hydrobromide is a cream to pale brown powder that is freely soluble in dimethylsulfoxide and sparingly soluble in methanol. Each eletriptan hydrobromide tablet for oral administration contains 24.230 or 48.461 mg of eletriptan hydrobromide equivalent to 20 mg or 40 mg of eletriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, FD&C yellow #6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin.</Description>
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