{
"NDC": [
{
"NDCCode": "67296-1202-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (67296-1202-3) ",
"NDC11Code": "67296-1202-03",
"ProductNDC": "67296-1202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076164",
"LabelerName": "RedPharm Drug, Inc.",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20111101",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Hypertension. Lisinopril is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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. 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 1 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. Lisinopril may be administered alone or with other antihypertensive agents [see CLINICAL STUDIES (14.1)]. 1.2 Heart Failure. Lisinopril is indicated to reduce signs and symptoms of systolic heart failure [see CLINICAL STUDIES (14.2)]. 1.3 Reduction of Mortality in Acute Myocardial Infarction. Lisinopril is indicated for the reduction of mortality in treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers [see CLINICAL STUDIES (14.3)].",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. [Chemical Structure]. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. 5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and yellow ferric oxide. 10 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and red ferric oxide. 20 and 30 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, magnesium stearate and red ferric oxide. 40 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, magnesium stearate and yellow ferric oxide. *: Pregelatinized starch is a physically modified corn (maize) starch."
},
{
"NDCCode": "67296-1202-1",
"PackageDescription": "30 TABLET in 1 BOTTLE (67296-1202-1) ",
"NDC11Code": "67296-1202-01",
"ProductNDC": "67296-1202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076164",
"LabelerName": "RedPharm Drug, Inc.",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20111101",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Hypertension. Lisinopril is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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. 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 1 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. Lisinopril may be administered alone or with other antihypertensive agents [see CLINICAL STUDIES (14.1)]. 1.2 Heart Failure. Lisinopril is indicated to reduce signs and symptoms of systolic heart failure [see CLINICAL STUDIES (14.2)]. 1.3 Reduction of Mortality in Acute Myocardial Infarction. Lisinopril is indicated for the reduction of mortality in treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers [see CLINICAL STUDIES (14.3)].",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. [Chemical Structure]. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. 5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and yellow ferric oxide. 10 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and red ferric oxide. 20 and 30 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, magnesium stearate and red ferric oxide. 40 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, magnesium stearate and yellow ferric oxide. *: Pregelatinized starch is a physically modified corn (maize) starch."
},
{
"NDCCode": "67296-1202-2",
"PackageDescription": "90 TABLET in 1 BOTTLE (67296-1202-2) ",
"NDC11Code": "67296-1202-02",
"ProductNDC": "67296-1202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076164",
"LabelerName": "RedPharm Drug, Inc.",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20111101",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Hypertension. Lisinopril is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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. 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 1 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. Lisinopril may be administered alone or with other antihypertensive agents [see CLINICAL STUDIES (14.1)]. 1.2 Heart Failure. Lisinopril is indicated to reduce signs and symptoms of systolic heart failure [see CLINICAL STUDIES (14.2)]. 1.3 Reduction of Mortality in Acute Myocardial Infarction. Lisinopril is indicated for the reduction of mortality in treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers [see CLINICAL STUDIES (14.3)].",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. [Chemical Structure]. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. 5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and yellow ferric oxide. 10 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and red ferric oxide. 20 and 30 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, magnesium stearate and red ferric oxide. 40 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, magnesium stearate and yellow ferric oxide. *: Pregelatinized starch is a physically modified corn (maize) starch."
},
{
"NDCCode": "67296-1202-6",
"PackageDescription": "60 TABLET in 1 BOTTLE (67296-1202-6) ",
"NDC11Code": "67296-1202-06",
"ProductNDC": "67296-1202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076164",
"LabelerName": "RedPharm Drug, Inc.",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20111101",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Hypertension. Lisinopril is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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. 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 1 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. Lisinopril may be administered alone or with other antihypertensive agents [see CLINICAL STUDIES (14.1)]. 1.2 Heart Failure. Lisinopril is indicated to reduce signs and symptoms of systolic heart failure [see CLINICAL STUDIES (14.2)]. 1.3 Reduction of Mortality in Acute Myocardial Infarction. Lisinopril is indicated for the reduction of mortality in treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers [see CLINICAL STUDIES (14.3)].",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. [Chemical Structure]. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. 5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and yellow ferric oxide. 10 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and red ferric oxide. 20 and 30 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, magnesium stearate and red ferric oxide. 40 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, magnesium stearate and yellow ferric oxide. *: Pregelatinized starch is a physically modified corn (maize) starch."
},
{
"NDCCode": "67296-1202-9",
"PackageDescription": "90 TABLET in 1 BOTTLE (67296-1202-9) ",
"NDC11Code": "67296-1202-09",
"ProductNDC": "67296-1202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20111101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076164",
"LabelerName": "RedPharm Drug, Inc.",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20111101",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Hypertension. Lisinopril is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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. 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 1 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. Lisinopril may be administered alone or with other antihypertensive agents [see CLINICAL STUDIES (14.1)]. 1.2 Heart Failure. Lisinopril is indicated to reduce signs and symptoms of systolic heart failure [see CLINICAL STUDIES (14.2)]. 1.3 Reduction of Mortality in Acute Myocardial Infarction. Lisinopril is indicated for the reduction of mortality in treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers [see CLINICAL STUDIES (14.3)].",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. [Chemical Structure]. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. 5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and yellow ferric oxide. 10 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and red ferric oxide. 20 and 30 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, magnesium stearate and red ferric oxide. 40 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, magnesium stearate and yellow ferric oxide. *: Pregelatinized starch is a physically modified corn (maize) starch."
},
{
"NDCCode": "10802-1202-3",
"PackageDescription": "3 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, UNIT-DOSE (10802-1202-3)",
"NDC11Code": "10802-1202-03",
"ProductNDC": "10802-1202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ergomar",
"NonProprietaryName": "Ergotamine Tartrate",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20120831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087693",
"LabelerName": "Rosedale Therapeutics",
"SubstanceName": "ERGOTAMINE TARTRATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Ergotamine Derivative [EPC],Ergotamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Ergomar® is indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or a so-called \"histaminic cephalalgia\".",
"Description": "Ergotamine Tartrate Sublingual Tablets USP 2 mg. Inactive Ingredients: Microcrystalline Cellulose NF, Natural Peppermint Flavor Powder, Crospovidone NF, Saccharin Sodium USP Powder, D&C Yellow #10 Lake, Magnesium Stearate NF, FD&C Blue #1 Aluminum Lake."
},
{
"NDCCode": "12496-1202-3",
"PackageDescription": "30 POUCH in 1 CARTON (12496-1202-3) / 1 FILM, SOLUBLE in 1 POUCH (12496-1202-1) ",
"NDC11Code": "12496-1202-03",
"ProductNDC": "12496-1202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Suboxone",
"NonProprietaryName": "Buprenorphine Hydrochloride, Naloxone Hydrochloride",
"DosageFormName": "FILM, SOLUBLE",
"RouteName": "BUCCAL; SUBLINGUAL",
"StartMarketingDate": "20100913",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022410",
"LabelerName": "INDIVIOR INC.",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE",
"StrengthNumber": "2; .5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100913",
"SamplePackage": "N",
"IndicationAndUsage": "SUBOXONE sublingual film is indicated for treatment of opioid dependence. SUBOXONE sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.",
"Description": "SUBOXONE® (buprenorphine and naloxone) sublingual film is an orange film, imprinted with a logo identifying the product and strength in white ink. It contains buprenorphine HCl, a mu-opioid receptor partial agonist, and a kappa-opioid receptor antagonist, and naloxone HCl dihydrate, an opioid antagonist, at a ratio of 4:1 (ratio of free bases). It is intended for sublingual or buccal administration and is available in four dosage strengths, 2 mg buprenorphine with 0.5 mg naloxone, 4 mg buprenorphine with 1 mg naloxone, 8 mg buprenorphine with 2 mg naloxone and 12 mg buprenorphine with 3 mg naloxone. Each film also contains polyethylene oxide, hydroxypropyl methylcellulose, maltitol, acesulfame potassium, lime flavor, citric acid, sodium citrate, FD&C yellow #6, and white ink. Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14- ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure. Buprenorphine HCl has the molecular formula C29H41NO4 HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. Chemically, naloxone HCl dihydrate is 17-Allyl-4,5 α -epoxy-3, 14-dihydroxymorphinan-6-one hydrochloride dihydrate. It has the following chemical structure. Naloxone hydrochloride dihydrate has the molecular formula C19H21NO4 HCl 2H2O and the molecular weight is 399.87. It is a white to slightly off-white powder and is freely soluble in water, soluble in alcohol, and practically insoluble in toluene and ether."
},
{
"NDCCode": "13845-1202-2",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (13845-1202-2) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "13845-1202-02",
"ProductNDC": "13845-1202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cycloserine",
"NonProprietaryName": "Cycloserine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA060593",
"LabelerName": "Parsolex Gmp Center, Inc.",
"SubstanceName": "CYCLOSERINE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20130912",
"SamplePackage": "N",
"IndicationAndUsage": "Cycloserine is indicated in the treatment of active pulmonary and extrapulmonary tuberculosis (including renal disease) when the causative organisms are susceptible to this drug and when treatment with the primary medications (streptomycin, isoniazid, rifampin, and ethambutol) has proved inadequate. Like all antituberculosis drugs, cycloserine should be administered in conjunction with other effective chemotherapy and not as the sole therapeutic agent. Cycloserine may be effective in the treatment of acute urinary tract infections caused by susceptible strains of gram-positive and gram- negative bacteria. Use of cycloserine in these infections should be considered only when more conventional therapy has failed and when the organism has been demonstrated to be susceptible to the drug.",
"Description": "D -Cycloserine, (R)-4-amino-3-isoxazolidinone, is a broad-spectrum antibiotic that is produced by a strain of Streptomyces orchidaceus and has also been synthesized. Cycloserine is a white to off-white powder that is soluble in water and stable in alkaline solution. It is rapidly destroyed at a neutral or acid pH. Cycloserine has a pH between 5.5 and 6.5 in a solution containing 100 mg/mL. The molecular weight of cycloserine is 102.09, and it has an empirical formula of C 3H6N2O 2 . The structural formula of cycloserine is as follows:. Each capsule contains cycloserine, 250 mg (2.45 mmol); D & C Yellow No. 10, F D & C Blue No. 1, F D & C Red No. 3, F D & C Yellow No. 6, gelatin, iron oxide, talc, and titanium dioxide."
},
{
"NDCCode": "36987-1202-3",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-1202-3)",
"NDC11Code": "36987-1202-03",
"ProductNDC": "36987-1202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Codfish",
"NonProprietaryName": "Codfish",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "CODFISH",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Fish Proteins, Dietary [EXT]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-1202-3",
"PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (37662-1202-3) ",
"NDC11Code": "37662-1202-03",
"ProductNDC": "37662-1202",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sabal Serrulata",
"NonProprietaryName": "Sabal Serrulata",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220804",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "SAW PALMETTO",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-08-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220804",
"SamplePackage": "N"
},
{
"NDCCode": "53002-1202-3",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (53002-1202-3) ",
"NDC11Code": "53002-1202-03",
"ProductNDC": "53002-1202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nortriptyline Hydrochloride",
"NonProprietaryName": "Nortriptyline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19950405",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074132",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "NORTRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "N",
"IndicationAndUsage": "Nortriptyline hydrochloride capsules are indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.",
"Description": "Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. C19H21NHCl M.W. 299.84. Nortriptyline hydrochloride, USP is a white to off-white powder, having a slight, characteristic odor. It is soluble in water and in chloroform; sparingly soluble in methanol; and practically insoluble in most organic solvents. Each capsule, for oral administration, contains nortriptyline hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg or 75 mg nortriptyline. In addition, each capsule contains the following inactive ingredients: corn starch, dimethicone, gelatin, iron oxide black, potassium hydroxide, propylene glycol, shellac glaze, sodium lauryl sulfate, strong ammonia solution, and titanium dioxide. The 10 mg, 25 mg and 75 mg capsules also contain D&C yellow #10, FD&C blue #1, and FD&C yellow #6."
},
{
"NDCCode": "60505-1202-3",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (60505-1202-3)",
"NDC11Code": "60505-1202-03",
"ProductNDC": "60505-1202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefuroxime Axetil",
"NonProprietaryName": "Cefuroxime Axetil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20021002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065069",
"LabelerName": "Apotex Corp.",
"SubstanceName": "CEFUROXIME AXETIL",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-12-14"
},
{
"NDCCode": "62991-1202-3",
"PackageDescription": "100 g in 1 JAR (62991-1202-3)",
"NDC11Code": "62991-1202-03",
"ProductNDC": "62991-1202",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Neomycin Sulfate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20090727",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "LETCO MEDICAL, LLC",
"SubstanceName": "NEOMYCIN SULFATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "64942-1202-4",
"PackageDescription": "1 CONTAINER in 1 CARTON (64942-1202-4) > 14 g in 1 CONTAINER (64942-1202-3) ",
"NDC11Code": "64942-1202-04",
"ProductNDC": "64942-1202",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Degree",
"ProprietaryNameSuffix": "Clinical Men Sport Strength Antiperspirant And Deodorant",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201030",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Conopco Inc. d/b/a Unilever",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "20",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2021-10-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20201030",
"SamplePackage": "N"
},
{
"NDCCode": "67046-1202-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1202-3) ",
"NDC11Code": "67046-1202-03",
"ProductNDC": "67046-1202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090162",
"LabelerName": "Coupler LLC",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260430",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate tablets are indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .",
"Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round shaped tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate, USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate, USP has the molecular formula C 12H 21NO 8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate Type A (Potato), magnesium stearate, hypromellose, polysorbate 80, polyethylene glycol, and titanium dioxide. In addition the 25 mg, 100 mg and 200 mg tablets also contain yellow iron oxide; the 25 mg and 100 mg tablets also contain red iron oxide."
},
{
"NDCCode": "70771-1202-3",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70771-1202-3) ",
"NDC11Code": "70771-1202-03",
"ProductNDC": "70771-1202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20180208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204663",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-05-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180208",
"SamplePackage": "N"
},
{
"NDCCode": "85509-1202-3",
"PackageDescription": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1202-3) ",
"NDC11Code": "85509-1202-03",
"ProductNDC": "85509-1202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen And Esomeprazole Magnesium",
"NonProprietaryName": "Naproxen And Esomeprazole Magnesium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20221006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213699",
"LabelerName": "PHOENIX RX LLC",
"SubstanceName": "NAPROXEN; ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "375; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250721",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen and esomeprazole magnesium delayed-release tablets, a combination of naproxen and esomeprazole magnesium, is indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers. The naproxen component of naproxen and esomeprazole magnesium delayed-release tablet is indicated for relief of signs and symptoms of: 1 osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults., 2 juvenile idiopathic arthritis (JIA) in adolescent patients.",
"Description": "The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen, USP which is an NSAID and esomeprazole magnesium, USP which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen, USP and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, talc, triethy citrate, hypromellose, macrogol, sodium lauryl sulfate, magnesium oxide, polyethylene glycol, ferric oxide yellow. The imprinting ink contains shellac glaze, black iron oxide, propylene glycol, ammonium hydroxide. The chemical name for naproxen, USP is (S)-2-(6-Methoxy-naphth-2-yl) propionic acid. Naproxen, USP has the following structure:. Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14H 14O 3. Naproxen, USP is an odorless, white to off-white crystalline powder. It is practically insoluble in water and soluble in ethanol and methanol. The octanol/water partition coefficient of naproxen is 3.18. The chemical name for esomeprazole is Magnesium bis [5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulphinyl]-1Hbenzimidazol-1- ide]dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. Its molecular formula is C 34H 36N 6O 6S 2Mg.2H 2O with molecular weight of 749.15 as a dihydrate and 713.15 on an anhydrous basis. The structural formula is:. The magnesium salt is a white to slightly colored powder. It contains 2 moles of water of solvation and is slightly soluble in methanol, practically insoluble in water and heptane. The stability of esomeprazole magnesium, USP is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C."
},
{
"NDCCode": "0088-1202-05",
"PackageDescription": "5 TABLET, FILM COATED in 1 BOTTLE (0088-1202-05)",
"NDC11Code": "00088-1202-05",
"ProductNDC": "0088-1202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Anzemet",
"NonProprietaryName": "Dolasetron Mesylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19970911",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020623",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "DOLASETRON MESYLATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-05-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0088-1202-43",
"PackageDescription": "10 TABLET, FILM COATED in 1 DOSE PACK (0088-1202-43)",
"NDC11Code": "00088-1202-43",
"ProductNDC": "0088-1202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Anzemet",
"NonProprietaryName": "Dolasetron Mesylate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19970911",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020623",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "DOLASETRON MESYLATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-05-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0480-4076-30",
"PackageDescription": "6 POUCH in 1 CARTON (0480-4076-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00480-4076-30",
"ProductNDC": "0480-4076",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclosporine",
"NonProprietaryName": "Cyclosporine",
"DosageFormName": "EMULSION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20251028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203880",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "CYCLOSPORINE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251028",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclosporine ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.",
"Description": "Cyclosporine ophthalmic emulsion, 0.05% contains a topical calcineurin inhibitor immunosuppressant with anti-inflammatory effects. Cyclosporine’s chemical name is Cyclo[[(E)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl] and it has the following structure. C62H111N11O12 M.W. 1202.6. Cyclosporine, USP is a white or almost white powder. Cyclosporine ophthalmic emulsion appears as a white opaque to slightly translucent homogeneous emulsion. It has an osmolality of 230 to 320 mOsmol/kg and a pH of 6.5 to 8.0. Each mL of cyclosporine ophthalmic emulsion contains: Active: cyclosporine, USP, 0.05%. Inactives: carbomer copolymer type A, castor oil, glycerin, polysorbate 80, water for injection and sodium hydroxide to adjust pH."
},
{
"NDCCode": "0480-4076-60",
"PackageDescription": "12 POUCH in 1 CARTON (0480-4076-60) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00480-4076-60",
"ProductNDC": "0480-4076",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclosporine",
"NonProprietaryName": "Cyclosporine",
"DosageFormName": "EMULSION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20251028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203880",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "CYCLOSPORINE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251028",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclosporine ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.",
"Description": "Cyclosporine ophthalmic emulsion, 0.05% contains a topical calcineurin inhibitor immunosuppressant with anti-inflammatory effects. Cyclosporine’s chemical name is Cyclo[[(E)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl] and it has the following structure. C62H111N11O12 M.W. 1202.6. Cyclosporine, USP is a white or almost white powder. Cyclosporine ophthalmic emulsion appears as a white opaque to slightly translucent homogeneous emulsion. It has an osmolality of 230 to 320 mOsmol/kg and a pH of 6.5 to 8.0. Each mL of cyclosporine ophthalmic emulsion contains: Active: cyclosporine, USP, 0.05%. Inactives: carbomer copolymer type A, castor oil, glycerin, polysorbate 80, water for injection and sodium hydroxide to adjust pH."
},
{
"NDCCode": "47335-506-96",
"PackageDescription": "6 POUCH in 1 BOX (47335-506-96) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "47335-0506-96",
"ProductNDC": "47335-506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cequa",
"NonProprietaryName": "Cyclosporine",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC; TOPICAL",
"StartMarketingDate": "20180815",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210913",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "CYCLOSPORINE",
"StrengthNumber": ".0009",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180815",
"SamplePackage": "N",
"IndicationAndUsage": "CEQUA ophthalmic solution is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye). (1).",
"Description": "CEQUA (cyclosporine ophthalmic solution) 0.09% contains a topical calcineurin inhibitor immunosuppressant. Cyclosporine’s chemical name is Cyclo[[(E)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl] and it has the following structure. Structural Formula. Formula: C62H111N11O12 Mol. Wt.: 1202.6. Cyclosporine is a white powder that is insoluble in water. CEQUA is supplied as a sterile, clear, colorless ophthalmic solution for topical ophthalmic use. It has an osmolality of 160 to 190 mOsmol/kg and a pH of 6.5-7.2. Each mL of CEQUA contains: : 1 Active: cyclosporine 0.09%, 2 Inactives: Polyoxyl 40 Hydrogenated Castor Oil, Octoxynol-40, polyvinylpyrrolidone, sodium phosphate monobasic dihydrate, sodium phosphate dibasic anhydrous, sodium chloride, water for injection, and sodium hydroxide or hydrochloric acid to adjust pH."
},
{
"NDCCode": "47335-507-97",
"PackageDescription": "1 POUCH in 1 BOX (47335-507-97) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "47335-0507-97",
"ProductNDC": "47335-507",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cequa",
"NonProprietaryName": "Cyclosporine",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC; TOPICAL",
"StartMarketingDate": "20180815",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210913",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "CYCLOSPORINE",
"StrengthNumber": ".0009",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180815",
"SamplePackage": "Y",
"IndicationAndUsage": "CEQUA ophthalmic solution is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye). (1).",
"Description": "CEQUA (cyclosporine ophthalmic solution) 0.09% contains a topical calcineurin inhibitor immunosuppressant. Cyclosporine’s chemical name is Cyclo[[(E)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl] and it has the following structure. Structural Formula. Formula: C62H111N11O12 Mol. Wt.: 1202.6. Cyclosporine is a white powder that is insoluble in water. CEQUA is supplied as a sterile, clear, colorless ophthalmic solution for topical ophthalmic use. It has an osmolality of 160 to 190 mOsmol/kg and a pH of 6.5-7.2. Each mL of CEQUA contains: : 1 Active: cyclosporine 0.09%, 2 Inactives: Polyoxyl 40 Hydrogenated Castor Oil, Octoxynol-40, polyvinylpyrrolidone, sodium phosphate monobasic dihydrate, sodium phosphate dibasic anhydrous, sodium chloride, water for injection, and sodium hydroxide or hydrochloric acid to adjust pH."
},
{
"NDCCode": "53002-1202-0",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (53002-1202-0) ",
"NDC11Code": "53002-1202-00",
"ProductNDC": "53002-1202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nortriptyline Hydrochloride",
"NonProprietaryName": "Nortriptyline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19950405",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074132",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "NORTRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "N",
"IndicationAndUsage": "Nortriptyline hydrochloride capsules are indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.",
"Description": "Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. C19H21NHCl M.W. 299.84. Nortriptyline hydrochloride, USP is a white to off-white powder, having a slight, characteristic odor. It is soluble in water and in chloroform; sparingly soluble in methanol; and practically insoluble in most organic solvents. Each capsule, for oral administration, contains nortriptyline hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg or 75 mg nortriptyline. In addition, each capsule contains the following inactive ingredients: corn starch, dimethicone, gelatin, iron oxide black, potassium hydroxide, propylene glycol, shellac glaze, sodium lauryl sulfate, strong ammonia solution, and titanium dioxide. The 10 mg, 25 mg and 75 mg capsules also contain D&C yellow #10, FD&C blue #1, and FD&C yellow #6."
},
{
"NDCCode": "67296-0007-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (67296-0007-3)",
"NDC11Code": "67296-0007-03",
"ProductNDC": "67296-0007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19890503",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071611",
"LabelerName": "RedPharm Drug, Inc.",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Cyclobenzaprine HCl is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H- dibenzo[a,d]cyclohepten-5-ylidene)- N , N -dimethyl-1- propanamine hydrochloride, and has the following structural formula. [cyclobenzaprine hydrochloride structural formula]. C20H21NHCl M.W. 311.9. Cyclobenzaprine hydrochloride tablets, USP are available for oral administration as 5 mg, 7.5 mg and 10 mg tablets. Cyclobenzaprine hydrochloride 5 mg, 7.5 mg and 10 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl cellulose, hypromellose, polyethylene glycol, magnesium stearate, microcrystalline cellulose, and titanium dioxide."
},
{
"NDCCode": "67296-0037-3",
"PackageDescription": "40 CAPSULE in 1 BOTTLE (67296-0037-3) ",
"NDC11Code": "67296-0037-03",
"ProductNDC": "67296-0037",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cephalexin",
"NonProprietaryName": "Cephalexin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062702",
"LabelerName": "RedPharm Drug, Inc.",
"SubstanceName": "CEPHALEXIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Indications and Usage.",
"Description": "Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid, monohydrate. Cephalexin, USP has the following structural formula. C 16H 17N 3O 4SH 2O M.W. 365.41. The nucleus of cephalexin, USP is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin, USP in water is approximately 4.5 to 5. The crystalline form of cephalexin, USP which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin, USP has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin monohydrate, USP equivalent to 250 mg (720 μmol) or 500 mg (1,439 μmol) of cephalexin. Inactive Ingredients: CAPSULES: magnesium stearate, silicon dioxide, and sodium starch glycolate. Capsule Shell and Print Constituents: black iron oxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, gelatin, pharmaceutical glaze modified in SD-45, silicon dioxide or carboxymethylcellulose sodium, sodium lauryl sulfate, titanium dioxide and may contain propylene glycol. In addition, the 250 mg capsule shell contains yellow iron oxide. After mixing, each 5 mL of cephalexin for oral suspension USP will contain cephalexin monohydrate, USP equivalent to 125 mg (360 μmol) or 250 mg (720 μmol) of cephalexin. Inactive Ingredients: SUSPENSION: FD&C Red #40, cherry mixed fruit flavor (artificial flavors, benzyl alcohol, maltodextrin, and modified corn starch), silicon dioxide, sodium benzoate, sugar (fruit granulated), and xanthan gum. Each tablet contains cephalexin monohydrate, USP equivalent to 250 mg (720 μmol) or 500 mg (1,439 μmol) of cephalexin. Inactive Ingredients: TABLETS: hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide."
},
{
"NDCCode": "67296-0044-3",
"PackageDescription": "28 TABLET in 1 BOTTLE (67296-0044-3) ",
"NDC11Code": "67296-0044-03",
"ProductNDC": "67296-0044",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillin V Potasium",
"NonProprietaryName": "Penicillin V Potasium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064071",
"LabelerName": "RedPharm Drug, Inc.",
"SubstanceName": "PENICILLIN V POTASSIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20010101",
"SamplePackage": "N",
"IndicationAndUsage": "Penicillin V potassium tablets are indicated in the treatment of mild to moderately severe infections due to penicillin G-sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following infections will usually respond to adequate dosage of penicillin V. Streptococcal Infections (without bacteremia). Mild-to-moderate infections of the upper respiratory tract, scarlet fever, and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus), are resistant. Pneumococcal Infections. Mild to moderately severe infections of the respiratory tract. Staphylococcal infections – penicillin G-sensitive. Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent’s gingivitis and pharyngitis). Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract1. Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g., those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha hemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association1. To reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin-VK and other antibacterial drugs, penicillin-VK should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. [Penicillin V Potassium Chemical Structure]. Molecular Formula: C16H17O5KN2S Molecular Weight: 388.5. Penicillin -VK (Penicillin V Potassium Tablets USP), for oral administration, contain 250 mg (400,000 units) or 500 mg (800,000 units) penicillin V. In addition, each tablet contains the following inactive ingredients: hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, povidone, talc, and titanium dioxide."
},
{
"NDCCode": "67296-0053-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (67296-0053-3)",
"NDC11Code": "67296-0053-03",
"ProductNDC": "67296-0053",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077797",
"LabelerName": "RedPharm Drug Inc.",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Cyclobenzaprine HCl is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "C20H21NHCl M.W. 311.9. Cyclobenzaprine hydrochloride tablets, USP are available for oral administration as 5 mg, 7.5 mg and 10 mg tablets. Cyclobenzaprine hydrochloride 5 mg, 7.5 mg and 10 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl cellulose, hypromellose, polyethylene glycol, magnesium stearate, microcrystalline cellulose, and titanium dioxide."
},
{
"NDCCode": "67296-0065-3",
"PackageDescription": "20 TABLET in 1 BOTTLE (67296-0065-3) ",
"NDC11Code": "67296-0065-03",
"ProductNDC": "67296-0065",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetaminophen And Codeine Phosphate",
"NonProprietaryName": "Acetaminophen And Codeine Phosphate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110706",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040419",
"LabelerName": "RedPharm Drug",
"SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
"StrengthNumber": "300; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20110706",
"SamplePackage": "N",
"IndicationAndUsage": "Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Have not been tolerated, or are not expected to be tolerated.",
"Description": "Acetaminophen and codeine phosphate tablets are available in tablet form for oral administration. Acetaminophen, 4′-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. [Acetaminophen Chemical Structure]. Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. [Codeine Phosphate Chemical Structure]. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/15 mg) contains. Acetaminophen USP………………..…300 mg Codeine Phosphate USP……………….15 mg. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/30 mg) contains. Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….30 mg. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/60 mg) contains. Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….60 mg. In addition, each tablet contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid."
},
{
"NDCCode": "67296-0078-3",
"PackageDescription": "21 TABLET in 1 BOTTLE (67296-0078-3) ",
"NDC11Code": "67296-0078-03",
"ProductNDC": "67296-0078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070033",
"LabelerName": "Redpharm Drug, inc.",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19900930",
"SamplePackage": "N",
"IndicationAndUsage": "Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures).",
"Description": "Metronidazole tablets USP, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 1 H-Imidazole-1-ethanol, 2-methyl-5-nitro, which has the following structural formula:. C 6H 9N 3O 3 M.W. 171.15. Metronidazole tablets, USP contain 250 mg or 500 mg of metronidazole, USP. Inactive ingredients include silicified microcrystalline cellulose, crospovidone, colloidal silicon dioxide and hydrogenated vegetable oil."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>67296-1202-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (67296-1202-3) </PackageDescription>
<NDC11Code>67296-1202-03</NDC11Code>
<ProductNDC>67296-1202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076164</ApplicationNumber>
<LabelerName>RedPharm Drug, Inc.</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Hypertension. Lisinopril is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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. 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 1 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. Lisinopril may be administered alone or with other antihypertensive agents [see CLINICAL STUDIES (14.1)]. 1.2 Heart Failure. Lisinopril is indicated to reduce signs and symptoms of systolic heart failure [see CLINICAL STUDIES (14.2)]. 1.3 Reduction of Mortality in Acute Myocardial Infarction. Lisinopril is indicated for the reduction of mortality in treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers [see CLINICAL STUDIES (14.3)].</IndicationAndUsage>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. [Chemical Structure]. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. 5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and yellow ferric oxide. 10 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and red ferric oxide. 20 and 30 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, magnesium stearate and red ferric oxide. 40 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, magnesium stearate and yellow ferric oxide. *: Pregelatinized starch is a physically modified corn (maize) starch.</Description>
</NDC>
<NDC>
<NDCCode>67296-1202-1</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (67296-1202-1) </PackageDescription>
<NDC11Code>67296-1202-01</NDC11Code>
<ProductNDC>67296-1202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076164</ApplicationNumber>
<LabelerName>RedPharm Drug, Inc.</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Hypertension. Lisinopril is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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. 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 1 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. Lisinopril may be administered alone or with other antihypertensive agents [see CLINICAL STUDIES (14.1)]. 1.2 Heart Failure. Lisinopril is indicated to reduce signs and symptoms of systolic heart failure [see CLINICAL STUDIES (14.2)]. 1.3 Reduction of Mortality in Acute Myocardial Infarction. Lisinopril is indicated for the reduction of mortality in treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers [see CLINICAL STUDIES (14.3)].</IndicationAndUsage>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. [Chemical Structure]. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. 5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and yellow ferric oxide. 10 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and red ferric oxide. 20 and 30 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, magnesium stearate and red ferric oxide. 40 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, magnesium stearate and yellow ferric oxide. *: Pregelatinized starch is a physically modified corn (maize) starch.</Description>
</NDC>
<NDC>
<NDCCode>67296-1202-2</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (67296-1202-2) </PackageDescription>
<NDC11Code>67296-1202-02</NDC11Code>
<ProductNDC>67296-1202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076164</ApplicationNumber>
<LabelerName>RedPharm Drug, Inc.</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Hypertension. Lisinopril is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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. 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 1 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. Lisinopril may be administered alone or with other antihypertensive agents [see CLINICAL STUDIES (14.1)]. 1.2 Heart Failure. Lisinopril is indicated to reduce signs and symptoms of systolic heart failure [see CLINICAL STUDIES (14.2)]. 1.3 Reduction of Mortality in Acute Myocardial Infarction. Lisinopril is indicated for the reduction of mortality in treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers [see CLINICAL STUDIES (14.3)].</IndicationAndUsage>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. [Chemical Structure]. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. 5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and yellow ferric oxide. 10 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and red ferric oxide. 20 and 30 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, magnesium stearate and red ferric oxide. 40 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, magnesium stearate and yellow ferric oxide. *: Pregelatinized starch is a physically modified corn (maize) starch.</Description>
</NDC>
<NDC>
<NDCCode>67296-1202-6</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (67296-1202-6) </PackageDescription>
<NDC11Code>67296-1202-06</NDC11Code>
<ProductNDC>67296-1202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076164</ApplicationNumber>
<LabelerName>RedPharm Drug, Inc.</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Hypertension. Lisinopril is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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. 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 1 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. Lisinopril may be administered alone or with other antihypertensive agents [see CLINICAL STUDIES (14.1)]. 1.2 Heart Failure. Lisinopril is indicated to reduce signs and symptoms of systolic heart failure [see CLINICAL STUDIES (14.2)]. 1.3 Reduction of Mortality in Acute Myocardial Infarction. Lisinopril is indicated for the reduction of mortality in treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers [see CLINICAL STUDIES (14.3)].</IndicationAndUsage>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. [Chemical Structure]. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. 5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and yellow ferric oxide. 10 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and red ferric oxide. 20 and 30 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, magnesium stearate and red ferric oxide. 40 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, magnesium stearate and yellow ferric oxide. *: Pregelatinized starch is a physically modified corn (maize) starch.</Description>
</NDC>
<NDC>
<NDCCode>67296-1202-9</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (67296-1202-9) </PackageDescription>
<NDC11Code>67296-1202-09</NDC11Code>
<ProductNDC>67296-1202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076164</ApplicationNumber>
<LabelerName>RedPharm Drug, Inc.</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Hypertension. Lisinopril is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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. 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 1 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. Lisinopril may be administered alone or with other antihypertensive agents [see CLINICAL STUDIES (14.1)]. 1.2 Heart Failure. Lisinopril is indicated to reduce signs and symptoms of systolic heart failure [see CLINICAL STUDIES (14.2)]. 1.3 Reduction of Mortality in Acute Myocardial Infarction. Lisinopril is indicated for the reduction of mortality in treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers [see CLINICAL STUDIES (14.3)].</IndicationAndUsage>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. [Chemical Structure]. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate and magnesium stearate. 5 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and yellow ferric oxide. 10 mg tablets – Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate and red ferric oxide. 20 and 30 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, magnesium stearate and red ferric oxide. 40 mg tablets - Mannitol, dibasic calcium phosphate, pregelatinized starch*, corn starch, colloidal silicon dioxide, magnesium stearate and yellow ferric oxide. *: Pregelatinized starch is a physically modified corn (maize) starch.</Description>
</NDC>
<NDC>
<NDCCode>10802-1202-3</NDCCode>
<PackageDescription>3 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, UNIT-DOSE (10802-1202-3)</PackageDescription>
<NDC11Code>10802-1202-03</NDC11Code>
<ProductNDC>10802-1202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ergomar</ProprietaryName>
<NonProprietaryName>Ergotamine Tartrate</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20120831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087693</ApplicationNumber>
<LabelerName>Rosedale Therapeutics</LabelerName>
<SubstanceName>ERGOTAMINE TARTRATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Ergotamine Derivative [EPC],Ergotamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ergomar® is indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or a so-called "histaminic cephalalgia".</IndicationAndUsage>
<Description>Ergotamine Tartrate Sublingual Tablets USP 2 mg. Inactive Ingredients: Microcrystalline Cellulose NF, Natural Peppermint Flavor Powder, Crospovidone NF, Saccharin Sodium USP Powder, D&C Yellow #10 Lake, Magnesium Stearate NF, FD&C Blue #1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>12496-1202-3</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (12496-1202-3) / 1 FILM, SOLUBLE in 1 POUCH (12496-1202-1) </PackageDescription>
<NDC11Code>12496-1202-03</NDC11Code>
<ProductNDC>12496-1202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Suboxone</ProprietaryName>
<NonProprietaryName>Buprenorphine Hydrochloride, Naloxone Hydrochloride</NonProprietaryName>
<DosageFormName>FILM, SOLUBLE</DosageFormName>
<RouteName>BUCCAL; SUBLINGUAL</RouteName>
<StartMarketingDate>20100913</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022410</ApplicationNumber>
<LabelerName>INDIVIOR INC.</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2; .5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SUBOXONE sublingual film is indicated for treatment of opioid dependence. SUBOXONE sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.</IndicationAndUsage>
<Description>SUBOXONE® (buprenorphine and naloxone) sublingual film is an orange film, imprinted with a logo identifying the product and strength in white ink. It contains buprenorphine HCl, a mu-opioid receptor partial agonist, and a kappa-opioid receptor antagonist, and naloxone HCl dihydrate, an opioid antagonist, at a ratio of 4:1 (ratio of free bases). It is intended for sublingual or buccal administration and is available in four dosage strengths, 2 mg buprenorphine with 0.5 mg naloxone, 4 mg buprenorphine with 1 mg naloxone, 8 mg buprenorphine with 2 mg naloxone and 12 mg buprenorphine with 3 mg naloxone. Each film also contains polyethylene oxide, hydroxypropyl methylcellulose, maltitol, acesulfame potassium, lime flavor, citric acid, sodium citrate, FD&C yellow #6, and white ink. Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14- ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure. Buprenorphine HCl has the molecular formula C29H41NO4 HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. Chemically, naloxone HCl dihydrate is 17-Allyl-4,5 α -epoxy-3, 14-dihydroxymorphinan-6-one hydrochloride dihydrate. It has the following chemical structure. Naloxone hydrochloride dihydrate has the molecular formula C19H21NO4 HCl 2H2O and the molecular weight is 399.87. It is a white to slightly off-white powder and is freely soluble in water, soluble in alcohol, and practically insoluble in toluene and ether.</Description>
</NDC>
<NDC>
<NDCCode>13845-1202-2</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (13845-1202-2) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>13845-1202-02</NDC11Code>
<ProductNDC>13845-1202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cycloserine</ProprietaryName>
<NonProprietaryName>Cycloserine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA060593</ApplicationNumber>
<LabelerName>Parsolex Gmp Center, Inc.</LabelerName>
<SubstanceName>CYCLOSERINE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cycloserine is indicated in the treatment of active pulmonary and extrapulmonary tuberculosis (including renal disease) when the causative organisms are susceptible to this drug and when treatment with the primary medications (streptomycin, isoniazid, rifampin, and ethambutol) has proved inadequate. Like all antituberculosis drugs, cycloserine should be administered in conjunction with other effective chemotherapy and not as the sole therapeutic agent. Cycloserine may be effective in the treatment of acute urinary tract infections caused by susceptible strains of gram-positive and gram- negative bacteria. Use of cycloserine in these infections should be considered only when more conventional therapy has failed and when the organism has been demonstrated to be susceptible to the drug.</IndicationAndUsage>
<Description>D -Cycloserine, (R)-4-amino-3-isoxazolidinone, is a broad-spectrum antibiotic that is produced by a strain of Streptomyces orchidaceus and has also been synthesized. Cycloserine is a white to off-white powder that is soluble in water and stable in alkaline solution. It is rapidly destroyed at a neutral or acid pH. Cycloserine has a pH between 5.5 and 6.5 in a solution containing 100 mg/mL. The molecular weight of cycloserine is 102.09, and it has an empirical formula of C 3H6N2O 2 . The structural formula of cycloserine is as follows:. Each capsule contains cycloserine, 250 mg (2.45 mmol); D & C Yellow No. 10, F D & C Blue No. 1, F D & C Red No. 3, F D & C Yellow No. 6, gelatin, iron oxide, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>36987-1202-3</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-1202-3)</PackageDescription>
<NDC11Code>36987-1202-03</NDC11Code>
<ProductNDC>36987-1202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Codfish</ProprietaryName>
<NonProprietaryName>Codfish</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>CODFISH</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Fish Proteins, Dietary [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>37662-1202-3</NDCCode>
<PackageDescription>1200 PELLET in 1 BOTTLE, GLASS (37662-1202-3) </PackageDescription>
<NDC11Code>37662-1202-03</NDC11Code>
<ProductNDC>37662-1202</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sabal Serrulata</ProprietaryName>
<NonProprietaryName>Sabal Serrulata</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220804</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>SAW PALMETTO</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-08-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>53002-1202-3</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (53002-1202-3) </PackageDescription>
<NDC11Code>53002-1202-03</NDC11Code>
<ProductNDC>53002-1202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nortriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Nortriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950405</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074132</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>NORTRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nortriptyline hydrochloride capsules are indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. C19H21NHCl M.W. 299.84. Nortriptyline hydrochloride, USP is a white to off-white powder, having a slight, characteristic odor. It is soluble in water and in chloroform; sparingly soluble in methanol; and practically insoluble in most organic solvents. Each capsule, for oral administration, contains nortriptyline hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg or 75 mg nortriptyline. In addition, each capsule contains the following inactive ingredients: corn starch, dimethicone, gelatin, iron oxide black, potassium hydroxide, propylene glycol, shellac glaze, sodium lauryl sulfate, strong ammonia solution, and titanium dioxide. The 10 mg, 25 mg and 75 mg capsules also contain D&C yellow #10, FD&C blue #1, and FD&C yellow #6.</Description>
</NDC>
<NDC>
<NDCCode>60505-1202-3</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (60505-1202-3)</PackageDescription>
<NDC11Code>60505-1202-03</NDC11Code>
<ProductNDC>60505-1202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefuroxime Axetil</ProprietaryName>
<NonProprietaryName>Cefuroxime Axetil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021002</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065069</ApplicationNumber>
<LabelerName>Apotex Corp.</LabelerName>
<SubstanceName>CEFUROXIME AXETIL</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-14</LastUpdate>
</NDC>
<NDC>
<NDCCode>62991-1202-3</NDCCode>
<PackageDescription>100 g in 1 JAR (62991-1202-3)</PackageDescription>
<NDC11Code>62991-1202-03</NDC11Code>
<ProductNDC>62991-1202</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Neomycin Sulfate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20090727</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>LETCO MEDICAL, LLC</LabelerName>
<SubstanceName>NEOMYCIN SULFATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>64942-1202-4</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (64942-1202-4) > 14 g in 1 CONTAINER (64942-1202-3) </PackageDescription>
<NDC11Code>64942-1202-04</NDC11Code>
<ProductNDC>64942-1202</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Degree</ProprietaryName>
<ProprietaryNameSuffix>Clinical Men Sport Strength Antiperspirant And Deodorant</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201030</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>Conopco Inc. d/b/a Unilever</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-10-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67046-1202-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1202-3) </PackageDescription>
<NDC11Code>67046-1202-03</NDC11Code>
<ProductNDC>67046-1202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260430</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090162</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate tablets are indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .</IndicationAndUsage>
<Description>Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round shaped tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate, USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate, USP has the molecular formula C 12H 21NO 8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate tablets, USP contain the following inactive ingredients: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, sodium starch glycolate Type A (Potato), magnesium stearate, hypromellose, polysorbate 80, polyethylene glycol, and titanium dioxide. In addition the 25 mg, 100 mg and 200 mg tablets also contain yellow iron oxide; the 25 mg and 100 mg tablets also contain red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>70771-1202-3</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70771-1202-3) </PackageDescription>
<NDC11Code>70771-1202-03</NDC11Code>
<ProductNDC>70771-1202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204663</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>85509-1202-3</NDCCode>
<PackageDescription>30 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1202-3) </PackageDescription>
<NDC11Code>85509-1202-03</NDC11Code>
<ProductNDC>85509-1202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen And Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Naproxen And Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213699</ApplicationNumber>
<LabelerName>PHOENIX RX LLC</LabelerName>
<SubstanceName>NAPROXEN; ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>375; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250721</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen and esomeprazole magnesium delayed-release tablets, a combination of naproxen and esomeprazole magnesium, is indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers. The naproxen component of naproxen and esomeprazole magnesium delayed-release tablet is indicated for relief of signs and symptoms of: 1 osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults., 2 juvenile idiopathic arthritis (JIA) in adolescent patients.</IndicationAndUsage>
<Description>The active ingredients of naproxen and esomeprazole magnesium delayed-release tablets are naproxen, USP which is an NSAID and esomeprazole magnesium, USP which is a Proton Pump Inhibitor (PPI). Naproxen and esomeprazole magnesium delayed-release tablets are combination of a nonsteroidal anti-inflammatory drug and a PPI available as an oval, yellow, multi-layer, delayed-release tablet combining an enteric-coated naproxen core and an immediate-release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen, USP and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) for oral administration. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, talc, triethy citrate, hypromellose, macrogol, sodium lauryl sulfate, magnesium oxide, polyethylene glycol, ferric oxide yellow. The imprinting ink contains shellac glaze, black iron oxide, propylene glycol, ammonium hydroxide. The chemical name for naproxen, USP is (S)-2-(6-Methoxy-naphth-2-yl) propionic acid. Naproxen, USP has the following structure:. Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14H 14O 3. Naproxen, USP is an odorless, white to off-white crystalline powder. It is practically insoluble in water and soluble in ethanol and methanol. The octanol/water partition coefficient of naproxen is 3.18. The chemical name for esomeprazole is Magnesium bis [5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulphinyl]-1Hbenzimidazol-1- ide]dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. Its molecular formula is C 34H 36N 6O 6S 2Mg.2H 2O with molecular weight of 749.15 as a dihydrate and 713.15 on an anhydrous basis. The structural formula is:. The magnesium salt is a white to slightly colored powder. It contains 2 moles of water of solvation and is slightly soluble in methanol, practically insoluble in water and heptane. The stability of esomeprazole magnesium, USP is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C.</Description>
</NDC>
<NDC>
<NDCCode>0088-1202-05</NDCCode>
<PackageDescription>5 TABLET, FILM COATED in 1 BOTTLE (0088-1202-05)</PackageDescription>
<NDC11Code>00088-1202-05</NDC11Code>
<ProductNDC>0088-1202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Anzemet</ProprietaryName>
<NonProprietaryName>Dolasetron Mesylate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970911</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020623</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>DOLASETRON MESYLATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-05-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0088-1202-43</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 DOSE PACK (0088-1202-43)</PackageDescription>
<NDC11Code>00088-1202-43</NDC11Code>
<ProductNDC>0088-1202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Anzemet</ProprietaryName>
<NonProprietaryName>Dolasetron Mesylate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970911</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020623</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>DOLASETRON MESYLATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-05-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0480-4076-30</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (0480-4076-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00480-4076-30</NDC11Code>
<ProductNDC>0480-4076</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclosporine</ProprietaryName>
<NonProprietaryName>Cyclosporine</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20251028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203880</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CYCLOSPORINE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclosporine ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.</IndicationAndUsage>
<Description>Cyclosporine ophthalmic emulsion, 0.05% contains a topical calcineurin inhibitor immunosuppressant with anti-inflammatory effects. Cyclosporine’s chemical name is Cyclo[[(E)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl] and it has the following structure. C62H111N11O12 M.W. 1202.6. Cyclosporine, USP is a white or almost white powder. Cyclosporine ophthalmic emulsion appears as a white opaque to slightly translucent homogeneous emulsion. It has an osmolality of 230 to 320 mOsmol/kg and a pH of 6.5 to 8.0. Each mL of cyclosporine ophthalmic emulsion contains: Active: cyclosporine, USP, 0.05%. Inactives: carbomer copolymer type A, castor oil, glycerin, polysorbate 80, water for injection and sodium hydroxide to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>0480-4076-60</NDCCode>
<PackageDescription>12 POUCH in 1 CARTON (0480-4076-60) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00480-4076-60</NDC11Code>
<ProductNDC>0480-4076</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclosporine</ProprietaryName>
<NonProprietaryName>Cyclosporine</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20251028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203880</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CYCLOSPORINE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclosporine ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.</IndicationAndUsage>
<Description>Cyclosporine ophthalmic emulsion, 0.05% contains a topical calcineurin inhibitor immunosuppressant with anti-inflammatory effects. Cyclosporine’s chemical name is Cyclo[[(E)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl] and it has the following structure. C62H111N11O12 M.W. 1202.6. Cyclosporine, USP is a white or almost white powder. Cyclosporine ophthalmic emulsion appears as a white opaque to slightly translucent homogeneous emulsion. It has an osmolality of 230 to 320 mOsmol/kg and a pH of 6.5 to 8.0. Each mL of cyclosporine ophthalmic emulsion contains: Active: cyclosporine, USP, 0.05%. Inactives: carbomer copolymer type A, castor oil, glycerin, polysorbate 80, water for injection and sodium hydroxide to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>47335-506-96</NDCCode>
<PackageDescription>6 POUCH in 1 BOX (47335-506-96) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>47335-0506-96</NDC11Code>
<ProductNDC>47335-506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cequa</ProprietaryName>
<NonProprietaryName>Cyclosporine</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC; TOPICAL</RouteName>
<StartMarketingDate>20180815</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210913</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>CYCLOSPORINE</SubstanceName>
<StrengthNumber>.0009</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CEQUA ophthalmic solution is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye). (1).</IndicationAndUsage>
<Description>CEQUA (cyclosporine ophthalmic solution) 0.09% contains a topical calcineurin inhibitor immunosuppressant. Cyclosporine’s chemical name is Cyclo[[(E)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl] and it has the following structure. Structural Formula. Formula: C62H111N11O12 Mol. Wt.: 1202.6. Cyclosporine is a white powder that is insoluble in water. CEQUA is supplied as a sterile, clear, colorless ophthalmic solution for topical ophthalmic use. It has an osmolality of 160 to 190 mOsmol/kg and a pH of 6.5-7.2. Each mL of CEQUA contains: : 1 Active: cyclosporine 0.09%, 2 Inactives: Polyoxyl 40 Hydrogenated Castor Oil, Octoxynol-40, polyvinylpyrrolidone, sodium phosphate monobasic dihydrate, sodium phosphate dibasic anhydrous, sodium chloride, water for injection, and sodium hydroxide or hydrochloric acid to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>47335-507-97</NDCCode>
<PackageDescription>1 POUCH in 1 BOX (47335-507-97) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>47335-0507-97</NDC11Code>
<ProductNDC>47335-507</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cequa</ProprietaryName>
<NonProprietaryName>Cyclosporine</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC; TOPICAL</RouteName>
<StartMarketingDate>20180815</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210913</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>CYCLOSPORINE</SubstanceName>
<StrengthNumber>.0009</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180815</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>CEQUA ophthalmic solution is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye). (1).</IndicationAndUsage>
<Description>CEQUA (cyclosporine ophthalmic solution) 0.09% contains a topical calcineurin inhibitor immunosuppressant. Cyclosporine’s chemical name is Cyclo[[(E)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl] and it has the following structure. Structural Formula. Formula: C62H111N11O12 Mol. Wt.: 1202.6. Cyclosporine is a white powder that is insoluble in water. CEQUA is supplied as a sterile, clear, colorless ophthalmic solution for topical ophthalmic use. It has an osmolality of 160 to 190 mOsmol/kg and a pH of 6.5-7.2. Each mL of CEQUA contains: : 1 Active: cyclosporine 0.09%, 2 Inactives: Polyoxyl 40 Hydrogenated Castor Oil, Octoxynol-40, polyvinylpyrrolidone, sodium phosphate monobasic dihydrate, sodium phosphate dibasic anhydrous, sodium chloride, water for injection, and sodium hydroxide or hydrochloric acid to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>53002-1202-0</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (53002-1202-0) </PackageDescription>
<NDC11Code>53002-1202-00</NDC11Code>
<ProductNDC>53002-1202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nortriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Nortriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950405</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074132</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>NORTRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nortriptyline hydrochloride capsules are indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. C19H21NHCl M.W. 299.84. Nortriptyline hydrochloride, USP is a white to off-white powder, having a slight, characteristic odor. It is soluble in water and in chloroform; sparingly soluble in methanol; and practically insoluble in most organic solvents. Each capsule, for oral administration, contains nortriptyline hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg or 75 mg nortriptyline. In addition, each capsule contains the following inactive ingredients: corn starch, dimethicone, gelatin, iron oxide black, potassium hydroxide, propylene glycol, shellac glaze, sodium lauryl sulfate, strong ammonia solution, and titanium dioxide. The 10 mg, 25 mg and 75 mg capsules also contain D&C yellow #10, FD&C blue #1, and FD&C yellow #6.</Description>
</NDC>
<NDC>
<NDCCode>67296-0007-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (67296-0007-3)</PackageDescription>
<NDC11Code>67296-0007-03</NDC11Code>
<ProductNDC>67296-0007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19890503</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071611</ApplicationNumber>
<LabelerName>RedPharm Drug, Inc.</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cyclobenzaprine HCl is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H- dibenzo[a,d]cyclohepten-5-ylidene)- N , N -dimethyl-1- propanamine hydrochloride, and has the following structural formula. [cyclobenzaprine hydrochloride structural formula]. C20H21NHCl M.W. 311.9. Cyclobenzaprine hydrochloride tablets, USP are available for oral administration as 5 mg, 7.5 mg and 10 mg tablets. Cyclobenzaprine hydrochloride 5 mg, 7.5 mg and 10 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl cellulose, hypromellose, polyethylene glycol, magnesium stearate, microcrystalline cellulose, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>67296-0037-3</NDCCode>
<PackageDescription>40 CAPSULE in 1 BOTTLE (67296-0037-3) </PackageDescription>
<NDC11Code>67296-0037-03</NDC11Code>
<ProductNDC>67296-0037</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cephalexin</ProprietaryName>
<NonProprietaryName>Cephalexin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062702</ApplicationNumber>
<LabelerName>RedPharm Drug, Inc.</LabelerName>
<SubstanceName>CEPHALEXIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications and Usage.</IndicationAndUsage>
<Description>Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-α-amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid, monohydrate. Cephalexin, USP has the following structural formula. C 16H 17N 3O 4SH 2O M.W. 365.41. The nucleus of cephalexin, USP is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin, USP in water is approximately 4.5 to 5. The crystalline form of cephalexin, USP which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin, USP has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin monohydrate, USP equivalent to 250 mg (720 μmol) or 500 mg (1,439 μmol) of cephalexin. Inactive Ingredients: CAPSULES: magnesium stearate, silicon dioxide, and sodium starch glycolate. Capsule Shell and Print Constituents: black iron oxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, gelatin, pharmaceutical glaze modified in SD-45, silicon dioxide or carboxymethylcellulose sodium, sodium lauryl sulfate, titanium dioxide and may contain propylene glycol. In addition, the 250 mg capsule shell contains yellow iron oxide. After mixing, each 5 mL of cephalexin for oral suspension USP will contain cephalexin monohydrate, USP equivalent to 125 mg (360 μmol) or 250 mg (720 μmol) of cephalexin. Inactive Ingredients: SUSPENSION: FD&C Red #40, cherry mixed fruit flavor (artificial flavors, benzyl alcohol, maltodextrin, and modified corn starch), silicon dioxide, sodium benzoate, sugar (fruit granulated), and xanthan gum. Each tablet contains cephalexin monohydrate, USP equivalent to 250 mg (720 μmol) or 500 mg (1,439 μmol) of cephalexin. Inactive Ingredients: TABLETS: hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>67296-0044-3</NDCCode>
<PackageDescription>28 TABLET in 1 BOTTLE (67296-0044-3) </PackageDescription>
<NDC11Code>67296-0044-03</NDC11Code>
<ProductNDC>67296-0044</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Penicillin V Potasium</ProprietaryName>
<NonProprietaryName>Penicillin V Potasium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064071</ApplicationNumber>
<LabelerName>RedPharm Drug, Inc.</LabelerName>
<SubstanceName>PENICILLIN V POTASSIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Penicillin V potassium tablets are indicated in the treatment of mild to moderately severe infections due to penicillin G-sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage. Indicated surgical procedures should be performed. The following infections will usually respond to adequate dosage of penicillin V. Streptococcal Infections (without bacteremia). Mild-to-moderate infections of the upper respiratory tract, scarlet fever, and mild erysipelas. NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus), are resistant. Pneumococcal Infections. Mild to moderately severe infections of the respiratory tract. Staphylococcal infections – penicillin G-sensitive. Mild infections of the skin and soft tissues. NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Fusospirochetosis (Vincent’s gingivitis and pharyngitis). Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. NOTE: Necessary dental care should be accomplished in infections involving the gum tissue. Medical conditions in which oral penicillin therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract1. Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g., those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha hemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association1. To reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin-VK and other antibacterial drugs, penicillin-VK should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. [Penicillin V Potassium Chemical Structure]. Molecular Formula: C16H17O5KN2S Molecular Weight: 388.5. Penicillin -VK (Penicillin V Potassium Tablets USP), for oral administration, contain 250 mg (400,000 units) or 500 mg (800,000 units) penicillin V. In addition, each tablet contains the following inactive ingredients: hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, povidone, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>67296-0053-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (67296-0053-3)</PackageDescription>
<NDC11Code>67296-0053-03</NDC11Code>
<ProductNDC>67296-0053</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077797</ApplicationNumber>
<LabelerName>RedPharm Drug Inc.</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cyclobenzaprine HCl is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>C20H21NHCl M.W. 311.9. Cyclobenzaprine hydrochloride tablets, USP are available for oral administration as 5 mg, 7.5 mg and 10 mg tablets. Cyclobenzaprine hydrochloride 5 mg, 7.5 mg and 10 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl cellulose, hypromellose, polyethylene glycol, magnesium stearate, microcrystalline cellulose, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>67296-0065-3</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (67296-0065-3) </PackageDescription>
<NDC11Code>67296-0065-03</NDC11Code>
<ProductNDC>67296-0065</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110706</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040419</ApplicationNumber>
<LabelerName>RedPharm Drug</LabelerName>
<SubstanceName>ACETAMINOPHEN; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>300; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110706</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics). Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Have not been tolerated, or are not expected to be tolerated.</IndicationAndUsage>
<Description>Acetaminophen and codeine phosphate tablets are available in tablet form for oral administration. Acetaminophen, 4′-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. [Acetaminophen Chemical Structure]. Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula. [Codeine Phosphate Chemical Structure]. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/15 mg) contains. Acetaminophen USP………………..…300 mg Codeine Phosphate USP……………….15 mg. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/30 mg) contains. Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….30 mg. Each Acetaminophen and Codeine Phosphate Tablet USP (300 mg/60 mg) contains. Acetaminophen USP……………..……300 mg Codeine Phosphate USP……………….60 mg. In addition, each tablet contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>67296-0078-3</NDCCode>
<PackageDescription>21 TABLET in 1 BOTTLE (67296-0078-3) </PackageDescription>
<NDC11Code>67296-0078-03</NDC11Code>
<ProductNDC>67296-0078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole</ProprietaryName>
<NonProprietaryName>Metronidazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070033</ApplicationNumber>
<LabelerName>Redpharm Drug, inc.</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19900930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures).</IndicationAndUsage>
<Description>Metronidazole tablets USP, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 1 H-Imidazole-1-ethanol, 2-methyl-5-nitro, which has the following structural formula:. C 6H 9N 3O 3 M.W. 171.15. Metronidazole tablets, USP contain 250 mg or 500 mg of metronidazole, USP. Inactive ingredients include silicified microcrystalline cellulose, crospovidone, colloidal silicon dioxide and hydrogenated vegetable oil.</Description>
</NDC>
</NDCList>