{
"NDC": [
{
"NDCCode": "62559-601-14",
"PackageDescription": "14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-601-14) ",
"NDC11Code": "62559-0601-14",
"ProductNDC": "62559-601",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Inderal Xl",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180222",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021438",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210901",
"SamplePackage": "N",
"IndicationAndUsage": "INDERAL XL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including beta-blockers. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg 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.",
"Description": "INDERAL XL contains propranolol hydrochloride, a nonselective, beta-adrenergic receptor-blocking agent for oral administration, as an extended-release product. INDERAL XL capsules contain sustained-release beads. Each of the beads contains propranolol hydrochloride and is coated with dual membranes. These membranes are designed to retard release of propranolol hydrochloride for several hours after ingestion followed by the sustained release of propranolol. INDERAL XL is available as 80 mg and 120 mg capsules for oral administration. : 1 Each 80 mg capsule contains 80 mg propranolol hydrochloride USP (equivalent to 70.14 mg of propranolol)., 2 Each 120 mg capsule contains 120 mg propranolol hydrochloride USP (equivalent to 105.21 mg of propranolol)."
},
{
"NDCCode": "62559-601-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-601-30) ",
"NDC11Code": "62559-0601-30",
"ProductNDC": "62559-601",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Inderal Xl",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180222",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021438",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180222",
"SamplePackage": "N",
"IndicationAndUsage": "INDERAL XL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including beta-blockers. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg 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.",
"Description": "INDERAL XL contains propranolol hydrochloride, a nonselective, beta-adrenergic receptor-blocking agent for oral administration, as an extended-release product. INDERAL XL capsules contain sustained-release beads. Each of the beads contains propranolol hydrochloride and is coated with dual membranes. These membranes are designed to retard release of propranolol hydrochloride for several hours after ingestion followed by the sustained release of propranolol. INDERAL XL is available as 80 mg and 120 mg capsules for oral administration. : 1 Each 80 mg capsule contains 80 mg propranolol hydrochloride USP (equivalent to 70.14 mg of propranolol)., 2 Each 120 mg capsule contains 120 mg propranolol hydrochloride USP (equivalent to 105.21 mg of propranolol)."
},
{
"NDCCode": "62559-601-77",
"PackageDescription": "7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-601-77) ",
"NDC11Code": "62559-0601-77",
"ProductNDC": "62559-601",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Inderal Xl",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180222",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021438",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180222",
"SamplePackage": "N",
"IndicationAndUsage": "INDERAL XL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including beta-blockers. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg 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.",
"Description": "INDERAL XL contains propranolol hydrochloride, a nonselective, beta-adrenergic receptor-blocking agent for oral administration, as an extended-release product. INDERAL XL capsules contain sustained-release beads. Each of the beads contains propranolol hydrochloride and is coated with dual membranes. These membranes are designed to retard release of propranolol hydrochloride for several hours after ingestion followed by the sustained release of propranolol. INDERAL XL is available as 80 mg and 120 mg capsules for oral administration. : 1 Each 80 mg capsule contains 80 mg propranolol hydrochloride USP (equivalent to 70.14 mg of propranolol)., 2 Each 120 mg capsule contains 120 mg propranolol hydrochloride USP (equivalent to 105.21 mg of propranolol)."
},
{
"NDCCode": "62559-590-14",
"PackageDescription": "14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-590-14) ",
"NDC11Code": "62559-0590-14",
"ProductNDC": "62559-590",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Innopran Xl",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180222",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021438",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210901",
"SamplePackage": "Y",
"IndicationAndUsage": "INNOPRAN XL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including beta-blockers. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg 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.",
"Description": "INNOPRAN XL contains propranolol hydrochloride, a nonselective, beta-adrenergic receptor-blocking agent for oral administration, as an extended-release product. INNOPRAN XL capsules contain sustained-release beads. Each of the beads contains propranolol hydrochloride and is coated with dual membranes. These membranes are designed to retard release of propranolol hydrochloride for several hours after ingestion followed by the sustained release of propranolol. INNOPRAN XL is available as 80 mg and 120 mg capsules for oral administration. : 1 Each 80 mg capsule contains 80 mg propranolol hydrochloride USP (equivalent to 70.14 mg of propranolol)., 2 Each 120 mg capsule contains 120 mg propranolol hydrochloride USP (equivalent to 105.21 mg of propranolol)."
},
{
"NDCCode": "62559-591-14",
"PackageDescription": "14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-591-14) ",
"NDC11Code": "62559-0591-14",
"ProductNDC": "62559-591",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Innopran Xl",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180222",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021438",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210901",
"SamplePackage": "Y",
"IndicationAndUsage": "INNOPRAN XL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including beta-blockers. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg 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.",
"Description": "INNOPRAN XL contains propranolol hydrochloride, a nonselective, beta-adrenergic receptor-blocking agent for oral administration, as an extended-release product. INNOPRAN XL capsules contain sustained-release beads. Each of the beads contains propranolol hydrochloride and is coated with dual membranes. These membranes are designed to retard release of propranolol hydrochloride for several hours after ingestion followed by the sustained release of propranolol. INNOPRAN XL is available as 80 mg and 120 mg capsules for oral administration. : 1 Each 80 mg capsule contains 80 mg propranolol hydrochloride USP (equivalent to 70.14 mg of propranolol)., 2 Each 120 mg capsule contains 120 mg propranolol hydrochloride USP (equivalent to 105.21 mg of propranolol)."
},
{
"NDCCode": "62559-600-14",
"PackageDescription": "14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-600-14) ",
"NDC11Code": "62559-0600-14",
"ProductNDC": "62559-600",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Inderal Xl",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180222",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021438",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210901",
"SamplePackage": "N",
"IndicationAndUsage": "INDERAL XL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including beta-blockers. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg 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.",
"Description": "INDERAL XL contains propranolol hydrochloride, a nonselective, beta-adrenergic receptor-blocking agent for oral administration, as an extended-release product. INDERAL XL capsules contain sustained-release beads. Each of the beads contains propranolol hydrochloride and is coated with dual membranes. These membranes are designed to retard release of propranolol hydrochloride for several hours after ingestion followed by the sustained release of propranolol. INDERAL XL is available as 80 mg and 120 mg capsules for oral administration. : 1 Each 80 mg capsule contains 80 mg propranolol hydrochloride USP (equivalent to 70.14 mg of propranolol)., 2 Each 120 mg capsule contains 120 mg propranolol hydrochloride USP (equivalent to 105.21 mg of propranolol)."
},
{
"NDCCode": "62559-920-14",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62559-920-14) > 14 CAPSULE in 1 BOTTLE, GLASS",
"NDC11Code": "62559-0920-14",
"ProductNDC": "62559-920",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temozolomide",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20201116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203490",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-05-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20201116",
"SamplePackage": "N"
},
{
"NDCCode": "62559-921-14",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62559-921-14) > 14 CAPSULE in 1 BOTTLE, GLASS",
"NDC11Code": "62559-0921-14",
"ProductNDC": "62559-921",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temozolomide",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20201116",
"EndMarketingDate": "20230228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203490",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201116",
"EndMarketingDatePackage": "20230228",
"SamplePackage": "N"
},
{
"NDCCode": "62559-922-14",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62559-922-14) > 14 CAPSULE in 1 BOTTLE, GLASS",
"NDC11Code": "62559-0922-14",
"ProductNDC": "62559-922",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temozolomide",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20201116",
"EndMarketingDate": "20230228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203490",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201116",
"EndMarketingDatePackage": "20230228",
"SamplePackage": "N"
},
{
"NDCCode": "62559-923-14",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62559-923-14) > 14 CAPSULE in 1 BOTTLE, GLASS",
"NDC11Code": "62559-0923-14",
"ProductNDC": "62559-923",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temozolomide",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20201116",
"EndMarketingDate": "20230228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203490",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "140",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201116",
"EndMarketingDatePackage": "20230228",
"SamplePackage": "N"
},
{
"NDCCode": "62559-924-14",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62559-924-14) > 14 CAPSULE in 1 BOTTLE, GLASS",
"NDC11Code": "62559-0924-14",
"ProductNDC": "62559-924",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temozolomide",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20201116",
"EndMarketingDate": "20230228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203490",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201116",
"EndMarketingDatePackage": "20230228",
"SamplePackage": "N"
},
{
"NDCCode": "36800-601-55",
"PackageDescription": "3 CARTON in 1 CARTON (36800-601-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK",
"NDC11Code": "36800-0601-55",
"ProductNDC": "36800-601",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topcare Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180402",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209400",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180402",
"SamplePackage": "N",
"IndicationAndUsage": "treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect."
},
{
"NDCCode": "36800-601-74",
"PackageDescription": "14 BLISTER PACK in 1 CARTON (36800-601-74) > 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK",
"NDC11Code": "36800-0601-74",
"ProductNDC": "36800-601",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topcare Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180402",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209400",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20180402",
"SamplePackage": "N",
"IndicationAndUsage": "treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect."
},
{
"NDCCode": "45334-601-14",
"PackageDescription": "4 g in 1 TUBE (45334-601-14) ",
"NDC11Code": "45334-0601-14",
"ProductNDC": "45334-601",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vaniply",
"NonProprietaryName": "Dimethicone",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170807",
"EndMarketingDate": "20200930",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Pharmaceutical Specialties, Inc.",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2020-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170907",
"EndMarketingDatePackage": "20200731",
"SamplePackage": "Y"
},
{
"NDCCode": "50157-601-14",
"PackageDescription": "1480 mL in 1 BOTTLE, PUMP (50157-601-14) ",
"NDC11Code": "50157-0601-14",
"ProductNDC": "50157-601",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial",
"ProprietaryNameSuffix": "Spring Rain",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220906",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Brands International Corporation",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/1000mL",
"Status": "Deprecated",
"LastUpdate": "2024-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20221114",
"SamplePackage": "N",
"IndicationAndUsage": "Use for handwashing to decrease bacteria on skin."
},
{
"NDCCode": "51316-601-14",
"PackageDescription": "500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51316-601-14) ",
"NDC11Code": "51316-0601-14",
"ProductNDC": "51316-601",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin 81 Mg",
"ProprietaryNameSuffix": "Low Dose",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250702",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "81",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250915",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief."
},
{
"NDCCode": "63187-601-14",
"PackageDescription": "14 TABLET in 1 BOTTLE (63187-601-14) ",
"NDC11Code": "63187-0601-14",
"ProductNDC": "63187-601",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine",
"ProprietaryNameSuffix": "Antihistamine",
"NonProprietaryName": "Loratadine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20081015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076301",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2022-04-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170801",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose , 2 itchy, watery eyes , 3 sneezing , 4 itching of the nose or throat."
},
{
"NDCCode": "64011-601-14",
"PackageDescription": "1 BOX in 1 BOX (64011-601-14) > 14 BLISTER PACK in 1 BOX > 1 INSERT in 1 BLISTER PACK",
"NDC11Code": "64011-0601-14",
"ProductNDC": "64011-601",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Intrarosa",
"NonProprietaryName": "Prasterone",
"DosageFormName": "INSERT",
"RouteName": "VAGINAL",
"StartMarketingDate": "20170724",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208470",
"LabelerName": "AMAG Pharmaceuticals, Inc.",
"SubstanceName": "PRASTERONE",
"StrengthNumber": "6.5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20170724",
"SamplePackage": "N",
"IndicationAndUsage": "INTRAROSA® is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.",
"Description": "INTRAROSA (prasterone) vaginal insert is a vaginally administered steroid. Prasterone is identified chemically as 3β-hydroxyandrost-5-en-17-one. It has the empirical formula C 19H 28O 2 with a molecular weight of 288.424 g/mol. Prasterone is a white to off-white crystalline powder insoluble in water and soluble in sodium lauryl sulfate (SLS). The structural formula is:. Each INTRAROSA (prasterone) vaginal insert contains 6.5 mg of prasterone in 1.3 ml of off-white hard fat (Witepsol)."
},
{
"NDCCode": "66116-601-14",
"PackageDescription": "14 TABLET in 1 BOTTLE (66116-601-14)",
"NDC11Code": "66116-0601-14",
"ProductNDC": "66116-601",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070033",
"LabelerName": "MedVantx, Inc.",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Metronidazole, USP is indicated for the treatment of symptomatic trichomoniasis in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures).",
"Description": "Metronidazole, USP is an oral synthetic antiprotozoal and antibacterial agent, 1-(β-hydroxyethyl)-2-methyl-5-nitroimidazole, which has the following structural formula. Each tablet for oral administration contains 250 mg or 500 mg of metronidazole, USP. Inactive ingredients include microcrystalline cellulose, crospovidone, colloidal silicon dioxide and hydrogenated vegetable oil."
},
{
"NDCCode": "69221-601-14",
"PackageDescription": "500 mL in 1 BOTTLE (69221-601-14) ",
"NDC11Code": "69221-0601-14",
"ProductNDC": "69221-601",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zoono Alcohol Free Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201120",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Zoono Holdings USA LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201120",
"EndMarketingDatePackage": "20261231",
"SamplePackage": "N",
"IndicationAndUsage": "Apply liberally to the hands and gently rub until dry."
},
{
"NDCCode": "75111-601-14",
"PackageDescription": "100 CLOTH in 1 BAG (75111-601-14) ",
"NDC11Code": "75111-0601-14",
"ProductNDC": "75111-601",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Wipes",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Enping Jiaxin Daily Necessities Co., Ltd.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "1/1001",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "77980-601-14",
"PackageDescription": "80 CLOTH in 1 CYLINDER (77980-601-14) ",
"NDC11Code": "77980-0601-14",
"ProductNDC": "77980-601",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sanitizing Wipes",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Foshan Clean & Simple Cleaning Products Co., Ltd.",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "3",
"StrengthUnit": "mL/1",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "SANITIZING WIPES to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "78092-601-14",
"PackageDescription": "10000 mL in 1 CONTAINER (78092-601-14) ",
"NDC11Code": "78092-0601-14",
"ProductNDC": "78092-601",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Securemax",
"ProprietaryNameSuffix": "Antibacterial Hand Cleansing",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200526",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "ATOMIZER KOZMETIK TURIZM VE YAPI SANAYI TICARET ANONIM SIRKETI",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "64.5",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200526",
"SamplePackage": "N",
"IndicationAndUsage": "To decrease bacteria on the skin and clean hands. Recommended for repeated use."
},
{
"NDCCode": "79539-601-14",
"PackageDescription": "120 CLOTH in 1 BAG (79539-601-14) ",
"NDC11Code": "79539-0601-14",
"ProductNDC": "79539-601",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Instant Hand Sanitizeing Wipe",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201121",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Shandong Yayun Sanitary Products Co., Ltd.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".05",
"StrengthUnit": "mg/1001",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20201121",
"SamplePackage": "N",
"IndicationAndUsage": "Instant Hand Sanitizeing Wipe to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "62559-151-16",
"PackageDescription": "1 BOTTLE in 1 CARTON (62559-151-16) / 473 mL in 1 BOTTLE",
"NDC11Code": "62559-0151-16",
"ProductNDC": "62559-151",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20151013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204979",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151013",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Oral Solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of UseBecause of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.2)], reserve opioid analgesics, including oxycodone hydrochloride, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone Hydrochloride Oral Solution USP is an opioid agonist, available as a solution in a 5 mg/5 mL (1 mg/mL) strength for oral administration. Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Oxycodone Hydrochloride Oral Solution USP, 5 mg per 5 mL contains the equivalent of 4.5 mg of oxycodone free base per 5 mL's and contains the following inactive ingredients: Poloxamer 188 NF, Sodium Benzoate NF, Citric Acid Anhydrous USP, Glycerin USP, Sorbitol Solution 70% USP, FD&C Red #40, Artificial Black Currant Flavor and Water."
},
{
"NDCCode": "62559-151-40",
"PackageDescription": "40 CUP, UNIT-DOSE in 1 CASE (62559-151-40) / 5 mL in 1 CUP, UNIT-DOSE (62559-151-15) ",
"NDC11Code": "62559-0151-40",
"ProductNDC": "62559-151",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20151013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204979",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240131",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Oral Solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.2)], reserve Oxycodone Hydrochloride Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia .",
"Description": "Oxycodone Hydrochloride Oral Solution USP is an opioid agonist, available as a solution in a 5 mg/5 mL (1 mg/mL) strength for oral administration. Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Oxycodone Hydrochloride Oral Solution USP, 5 mg per 5 mL contains the equivalent of 4.5 mg of oxycodone free base per 5 mL's and contains the following inactive ingredients: Poloxamer 188 NF, Sodium Benzoate NF, Citric Acid Anhydrous USP, Glycerin USP, Sorbitol Solution 70% USP, FD&C Red #40, Artificial Black Currant Flavor and Water."
},
{
"NDCCode": "62559-151-50",
"PackageDescription": "50 CUP, UNIT-DOSE in 1 CASE (62559-151-50) / 5 mL in 1 CUP, UNIT-DOSE (62559-151-15) ",
"NDC11Code": "62559-0151-50",
"ProductNDC": "62559-151",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20151013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204979",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240131",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Oral Solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.2)], reserve Oxycodone Hydrochloride Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia .",
"Description": "Oxycodone Hydrochloride Oral Solution USP is an opioid agonist, available as a solution in a 5 mg/5 mL (1 mg/mL) strength for oral administration. Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Oxycodone Hydrochloride Oral Solution USP, 5 mg per 5 mL contains the equivalent of 4.5 mg of oxycodone free base per 5 mL's and contains the following inactive ingredients: Poloxamer 188 NF, Sodium Benzoate NF, Citric Acid Anhydrous USP, Glycerin USP, Sorbitol Solution 70% USP, FD&C Red #40, Artificial Black Currant Flavor and Water."
},
{
"NDCCode": "62559-167-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (62559-167-01) ",
"NDC11Code": "62559-0167-01",
"ProductNDC": "62559-167",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205177",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160610",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Capsules are an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. : 1 Limitations of UseBecause of the risks of addiction, abuse, and misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including Oxycodone Hydrochloride Capsules, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone Hydrochloride Capsules are an agonist, available as a hard gelatin capsule 5 mg for oral administration. The chemical name is (5R,9R,13S,14S)-4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C18H21NO4∙HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. It is soluble in water and slightly soluble in alcohol. The inactive ingredients in Oxycodone Hydrochloride Capsules 5 mg include: colloidal silicon dioxide, gelatin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, FD&C yellow #6, titanium dioxide, yellow iron oxide, shellac glaze, iron oxide black, propylene glycol, and ammonium hydroxide."
},
{
"NDCCode": "62559-220-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (62559-220-01) ",
"NDC11Code": "62559-0220-01",
"ProductNDC": "62559-220",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxcarbazepine",
"NonProprietaryName": "Oxcarbazepine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078005",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "OXCARBAZEPINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250715",
"SamplePackage": "N",
"IndicationAndUsage": "Oxcarbazepine Tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.",
"Description": "Oxcarbazepine Tablets USP are an AED available as 150 mg, 300 mg, and 600 mg film-coated tablets for oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo- 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is a white to faintly orange crystalline powder. It is slightly soluble in chloroform, dichloromethane, acetone, and methanol and practically insoluble in ethanol, ether and water. Its molecular weight is 252.27 g/mol. Oxcarbazepine Tablets USP contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide. Oxcarbazepine Tablets USP meet USP Organic Impurities Test 2."
},
{
"NDCCode": "62559-220-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (62559-220-05) ",
"NDC11Code": "62559-0220-05",
"ProductNDC": "62559-220",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxcarbazepine",
"NonProprietaryName": "Oxcarbazepine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078005",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "OXCARBAZEPINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250715",
"SamplePackage": "N",
"IndicationAndUsage": "Oxcarbazepine Tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.",
"Description": "Oxcarbazepine Tablets USP are an AED available as 150 mg, 300 mg, and 600 mg film-coated tablets for oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo- 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is a white to faintly orange crystalline powder. It is slightly soluble in chloroform, dichloromethane, acetone, and methanol and practically insoluble in ethanol, ether and water. Its molecular weight is 252.27 g/mol. Oxcarbazepine Tablets USP contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide. Oxcarbazepine Tablets USP meet USP Organic Impurities Test 2."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>62559-601-14</NDCCode>
<PackageDescription>14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-601-14) </PackageDescription>
<NDC11Code>62559-0601-14</NDC11Code>
<ProductNDC>62559-601</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Inderal Xl</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180222</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021438</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDERAL XL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including beta-blockers. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg 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.</IndicationAndUsage>
<Description>INDERAL XL contains propranolol hydrochloride, a nonselective, beta-adrenergic receptor-blocking agent for oral administration, as an extended-release product. INDERAL XL capsules contain sustained-release beads. Each of the beads contains propranolol hydrochloride and is coated with dual membranes. These membranes are designed to retard release of propranolol hydrochloride for several hours after ingestion followed by the sustained release of propranolol. INDERAL XL is available as 80 mg and 120 mg capsules for oral administration. : 1 Each 80 mg capsule contains 80 mg propranolol hydrochloride USP (equivalent to 70.14 mg of propranolol)., 2 Each 120 mg capsule contains 120 mg propranolol hydrochloride USP (equivalent to 105.21 mg of propranolol).</Description>
</NDC>
<NDC>
<NDCCode>62559-601-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-601-30) </PackageDescription>
<NDC11Code>62559-0601-30</NDC11Code>
<ProductNDC>62559-601</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Inderal Xl</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180222</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021438</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDERAL XL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including beta-blockers. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg 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.</IndicationAndUsage>
<Description>INDERAL XL contains propranolol hydrochloride, a nonselective, beta-adrenergic receptor-blocking agent for oral administration, as an extended-release product. INDERAL XL capsules contain sustained-release beads. Each of the beads contains propranolol hydrochloride and is coated with dual membranes. These membranes are designed to retard release of propranolol hydrochloride for several hours after ingestion followed by the sustained release of propranolol. INDERAL XL is available as 80 mg and 120 mg capsules for oral administration. : 1 Each 80 mg capsule contains 80 mg propranolol hydrochloride USP (equivalent to 70.14 mg of propranolol)., 2 Each 120 mg capsule contains 120 mg propranolol hydrochloride USP (equivalent to 105.21 mg of propranolol).</Description>
</NDC>
<NDC>
<NDCCode>62559-601-77</NDCCode>
<PackageDescription>7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-601-77) </PackageDescription>
<NDC11Code>62559-0601-77</NDC11Code>
<ProductNDC>62559-601</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Inderal Xl</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180222</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021438</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDERAL XL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including beta-blockers. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg 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.</IndicationAndUsage>
<Description>INDERAL XL contains propranolol hydrochloride, a nonselective, beta-adrenergic receptor-blocking agent for oral administration, as an extended-release product. INDERAL XL capsules contain sustained-release beads. Each of the beads contains propranolol hydrochloride and is coated with dual membranes. These membranes are designed to retard release of propranolol hydrochloride for several hours after ingestion followed by the sustained release of propranolol. INDERAL XL is available as 80 mg and 120 mg capsules for oral administration. : 1 Each 80 mg capsule contains 80 mg propranolol hydrochloride USP (equivalent to 70.14 mg of propranolol)., 2 Each 120 mg capsule contains 120 mg propranolol hydrochloride USP (equivalent to 105.21 mg of propranolol).</Description>
</NDC>
<NDC>
<NDCCode>62559-590-14</NDCCode>
<PackageDescription>14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-590-14) </PackageDescription>
<NDC11Code>62559-0590-14</NDC11Code>
<ProductNDC>62559-590</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Innopran Xl</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180222</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021438</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210901</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>INNOPRAN XL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including beta-blockers. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg 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.</IndicationAndUsage>
<Description>INNOPRAN XL contains propranolol hydrochloride, a nonselective, beta-adrenergic receptor-blocking agent for oral administration, as an extended-release product. INNOPRAN XL capsules contain sustained-release beads. Each of the beads contains propranolol hydrochloride and is coated with dual membranes. These membranes are designed to retard release of propranolol hydrochloride for several hours after ingestion followed by the sustained release of propranolol. INNOPRAN XL is available as 80 mg and 120 mg capsules for oral administration. : 1 Each 80 mg capsule contains 80 mg propranolol hydrochloride USP (equivalent to 70.14 mg of propranolol)., 2 Each 120 mg capsule contains 120 mg propranolol hydrochloride USP (equivalent to 105.21 mg of propranolol).</Description>
</NDC>
<NDC>
<NDCCode>62559-591-14</NDCCode>
<PackageDescription>14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-591-14) </PackageDescription>
<NDC11Code>62559-0591-14</NDC11Code>
<ProductNDC>62559-591</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Innopran Xl</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180222</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021438</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210901</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>INNOPRAN XL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including beta-blockers. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg 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.</IndicationAndUsage>
<Description>INNOPRAN XL contains propranolol hydrochloride, a nonselective, beta-adrenergic receptor-blocking agent for oral administration, as an extended-release product. INNOPRAN XL capsules contain sustained-release beads. Each of the beads contains propranolol hydrochloride and is coated with dual membranes. These membranes are designed to retard release of propranolol hydrochloride for several hours after ingestion followed by the sustained release of propranolol. INNOPRAN XL is available as 80 mg and 120 mg capsules for oral administration. : 1 Each 80 mg capsule contains 80 mg propranolol hydrochloride USP (equivalent to 70.14 mg of propranolol)., 2 Each 120 mg capsule contains 120 mg propranolol hydrochloride USP (equivalent to 105.21 mg of propranolol).</Description>
</NDC>
<NDC>
<NDCCode>62559-600-14</NDCCode>
<PackageDescription>14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-600-14) </PackageDescription>
<NDC11Code>62559-0600-14</NDC11Code>
<ProductNDC>62559-600</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Inderal Xl</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180222</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021438</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDERAL XL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including beta-blockers. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg 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.</IndicationAndUsage>
<Description>INDERAL XL contains propranolol hydrochloride, a nonselective, beta-adrenergic receptor-blocking agent for oral administration, as an extended-release product. INDERAL XL capsules contain sustained-release beads. Each of the beads contains propranolol hydrochloride and is coated with dual membranes. These membranes are designed to retard release of propranolol hydrochloride for several hours after ingestion followed by the sustained release of propranolol. INDERAL XL is available as 80 mg and 120 mg capsules for oral administration. : 1 Each 80 mg capsule contains 80 mg propranolol hydrochloride USP (equivalent to 70.14 mg of propranolol)., 2 Each 120 mg capsule contains 120 mg propranolol hydrochloride USP (equivalent to 105.21 mg of propranolol).</Description>
</NDC>
<NDC>
<NDCCode>62559-920-14</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62559-920-14) > 14 CAPSULE in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62559-0920-14</NDC11Code>
<ProductNDC>62559-920</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temozolomide</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203490</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-05-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62559-921-14</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62559-921-14) > 14 CAPSULE in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62559-0921-14</NDC11Code>
<ProductNDC>62559-921</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temozolomide</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201116</StartMarketingDate>
<EndMarketingDate>20230228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203490</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201116</StartMarketingDatePackage>
<EndMarketingDatePackage>20230228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62559-922-14</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62559-922-14) > 14 CAPSULE in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62559-0922-14</NDC11Code>
<ProductNDC>62559-922</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temozolomide</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201116</StartMarketingDate>
<EndMarketingDate>20230228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203490</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201116</StartMarketingDatePackage>
<EndMarketingDatePackage>20230228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62559-923-14</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62559-923-14) > 14 CAPSULE in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62559-0923-14</NDC11Code>
<ProductNDC>62559-923</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temozolomide</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201116</StartMarketingDate>
<EndMarketingDate>20230228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203490</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>140</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201116</StartMarketingDatePackage>
<EndMarketingDatePackage>20230228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62559-924-14</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62559-924-14) > 14 CAPSULE in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62559-0924-14</NDC11Code>
<ProductNDC>62559-924</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temozolomide</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201116</StartMarketingDate>
<EndMarketingDate>20230228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203490</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201116</StartMarketingDatePackage>
<EndMarketingDatePackage>20230228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>36800-601-55</NDCCode>
<PackageDescription>3 CARTON in 1 CARTON (36800-601-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>36800-0601-55</NDC11Code>
<ProductNDC>36800-601</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topcare Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180402</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209400</ApplicationNumber>
<LabelerName>Topco Associates LLC</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36800-601-74</NDCCode>
<PackageDescription>14 BLISTER PACK in 1 CARTON (36800-601-74) > 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>36800-0601-74</NDC11Code>
<ProductNDC>36800-601</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topcare Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180402</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209400</ApplicationNumber>
<LabelerName>Topco Associates LLC</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>45334-601-14</NDCCode>
<PackageDescription>4 g in 1 TUBE (45334-601-14) </PackageDescription>
<NDC11Code>45334-0601-14</NDC11Code>
<ProductNDC>45334-601</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vaniply</ProprietaryName>
<NonProprietaryName>Dimethicone</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170807</StartMarketingDate>
<EndMarketingDate>20200930</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Pharmaceutical Specialties, Inc.</LabelerName>
<SubstanceName>DIMETHICONE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170907</StartMarketingDatePackage>
<EndMarketingDatePackage>20200731</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>50157-601-14</NDCCode>
<PackageDescription>1480 mL in 1 BOTTLE, PUMP (50157-601-14) </PackageDescription>
<NDC11Code>50157-0601-14</NDC11Code>
<ProductNDC>50157-601</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial</ProprietaryName>
<ProprietaryNameSuffix>Spring Rain</ProprietaryNameSuffix>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220906</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Brands International Corporation</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/1000mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use for handwashing to decrease bacteria on skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51316-601-14</NDCCode>
<PackageDescription>500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51316-601-14) </PackageDescription>
<NDC11Code>51316-0601-14</NDC11Code>
<ProductNDC>51316-601</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspirin 81 Mg</ProprietaryName>
<ProprietaryNameSuffix>Low Dose</ProprietaryNameSuffix>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250702</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>81</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63187-601-14</NDCCode>
<PackageDescription>14 TABLET in 1 BOTTLE (63187-601-14) </PackageDescription>
<NDC11Code>63187-0601-14</NDC11Code>
<ProductNDC>63187-601</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loratadine</ProprietaryName>
<ProprietaryNameSuffix>Antihistamine</ProprietaryNameSuffix>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076301</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-04-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose , 2 itchy, watery eyes , 3 sneezing , 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64011-601-14</NDCCode>
<PackageDescription>1 BOX in 1 BOX (64011-601-14) > 14 BLISTER PACK in 1 BOX > 1 INSERT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64011-0601-14</NDC11Code>
<ProductNDC>64011-601</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Intrarosa</ProprietaryName>
<NonProprietaryName>Prasterone</NonProprietaryName>
<DosageFormName>INSERT</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20170724</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208470</ApplicationNumber>
<LabelerName>AMAG Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PRASTERONE</SubstanceName>
<StrengthNumber>6.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INTRAROSA® is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.</IndicationAndUsage>
<Description>INTRAROSA (prasterone) vaginal insert is a vaginally administered steroid. Prasterone is identified chemically as 3β-hydroxyandrost-5-en-17-one. It has the empirical formula C 19H 28O 2 with a molecular weight of 288.424 g/mol. Prasterone is a white to off-white crystalline powder insoluble in water and soluble in sodium lauryl sulfate (SLS). The structural formula is:. Each INTRAROSA (prasterone) vaginal insert contains 6.5 mg of prasterone in 1.3 ml of off-white hard fat (Witepsol).</Description>
</NDC>
<NDC>
<NDCCode>66116-601-14</NDCCode>
<PackageDescription>14 TABLET in 1 BOTTLE (66116-601-14)</PackageDescription>
<NDC11Code>66116-0601-14</NDC11Code>
<ProductNDC>66116-601</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>MedVantx, Inc.</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Metronidazole, USP is indicated for the treatment of symptomatic trichomoniasis 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, USP is an oral synthetic antiprotozoal and antibacterial agent, 1-(β-hydroxyethyl)-2-methyl-5-nitroimidazole, which has the following structural formula. Each tablet for oral administration contains 250 mg or 500 mg of metronidazole, USP. Inactive ingredients include microcrystalline cellulose, crospovidone, colloidal silicon dioxide and hydrogenated vegetable oil.</Description>
</NDC>
<NDC>
<NDCCode>69221-601-14</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE (69221-601-14) </PackageDescription>
<NDC11Code>69221-0601-14</NDC11Code>
<ProductNDC>69221-601</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zoono Alcohol Free Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201120</StartMarketingDate>
<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Zoono Holdings USA LLC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201120</StartMarketingDatePackage>
<EndMarketingDatePackage>20261231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply liberally to the hands and gently rub until dry.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75111-601-14</NDCCode>
<PackageDescription>100 CLOTH in 1 BAG (75111-601-14) </PackageDescription>
<NDC11Code>75111-0601-14</NDC11Code>
<ProductNDC>75111-601</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Wipes</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Enping Jiaxin Daily Necessities Co., Ltd.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>1/1001</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>77980-601-14</NDCCode>
<PackageDescription>80 CLOTH in 1 CYLINDER (77980-601-14) </PackageDescription>
<NDC11Code>77980-0601-14</NDC11Code>
<ProductNDC>77980-601</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sanitizing Wipes</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Foshan Clean & Simple Cleaning Products Co., Ltd.</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mL/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SANITIZING WIPES to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>78092-601-14</NDCCode>
<PackageDescription>10000 mL in 1 CONTAINER (78092-601-14) </PackageDescription>
<NDC11Code>78092-0601-14</NDC11Code>
<ProductNDC>78092-601</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Securemax</ProprietaryName>
<ProprietaryNameSuffix>Antibacterial Hand Cleansing</ProprietaryNameSuffix>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200526</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>ATOMIZER KOZMETIK TURIZM VE YAPI SANAYI TICARET ANONIM SIRKETI</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>64.5</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200526</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To decrease bacteria on the skin and clean hands. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79539-601-14</NDCCode>
<PackageDescription>120 CLOTH in 1 BAG (79539-601-14) </PackageDescription>
<NDC11Code>79539-0601-14</NDC11Code>
<ProductNDC>79539-601</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Instant Hand Sanitizeing Wipe</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201121</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Shandong Yayun Sanitary Products Co., Ltd.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>mg/1001</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Instant Hand Sanitizeing Wipe to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62559-151-16</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (62559-151-16) / 473 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>62559-0151-16</NDC11Code>
<ProductNDC>62559-151</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204979</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Oral Solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of UseBecause of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.2)], reserve opioid analgesics, including oxycodone hydrochloride, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Oral Solution USP is an opioid agonist, available as a solution in a 5 mg/5 mL (1 mg/mL) strength for oral administration. Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Oxycodone Hydrochloride Oral Solution USP, 5 mg per 5 mL contains the equivalent of 4.5 mg of oxycodone free base per 5 mL's and contains the following inactive ingredients: Poloxamer 188 NF, Sodium Benzoate NF, Citric Acid Anhydrous USP, Glycerin USP, Sorbitol Solution 70% USP, FD&C Red #40, Artificial Black Currant Flavor and Water.</Description>
</NDC>
<NDC>
<NDCCode>62559-151-40</NDCCode>
<PackageDescription>40 CUP, UNIT-DOSE in 1 CASE (62559-151-40) / 5 mL in 1 CUP, UNIT-DOSE (62559-151-15) </PackageDescription>
<NDC11Code>62559-0151-40</NDC11Code>
<ProductNDC>62559-151</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204979</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Oral Solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.2)], reserve Oxycodone Hydrochloride Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia .</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Oral Solution USP is an opioid agonist, available as a solution in a 5 mg/5 mL (1 mg/mL) strength for oral administration. Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Oxycodone Hydrochloride Oral Solution USP, 5 mg per 5 mL contains the equivalent of 4.5 mg of oxycodone free base per 5 mL's and contains the following inactive ingredients: Poloxamer 188 NF, Sodium Benzoate NF, Citric Acid Anhydrous USP, Glycerin USP, Sorbitol Solution 70% USP, FD&C Red #40, Artificial Black Currant Flavor and Water.</Description>
</NDC>
<NDC>
<NDCCode>62559-151-50</NDCCode>
<PackageDescription>50 CUP, UNIT-DOSE in 1 CASE (62559-151-50) / 5 mL in 1 CUP, UNIT-DOSE (62559-151-15) </PackageDescription>
<NDC11Code>62559-0151-50</NDC11Code>
<ProductNDC>62559-151</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204979</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Oral Solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.2)], reserve Oxycodone Hydrochloride Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 1 Have not been tolerated or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia .</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Oral Solution USP is an opioid agonist, available as a solution in a 5 mg/5 mL (1 mg/mL) strength for oral administration. Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Oxycodone Hydrochloride Oral Solution USP, 5 mg per 5 mL contains the equivalent of 4.5 mg of oxycodone free base per 5 mL's and contains the following inactive ingredients: Poloxamer 188 NF, Sodium Benzoate NF, Citric Acid Anhydrous USP, Glycerin USP, Sorbitol Solution 70% USP, FD&C Red #40, Artificial Black Currant Flavor and Water.</Description>
</NDC>
<NDC>
<NDCCode>62559-167-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (62559-167-01) </PackageDescription>
<NDC11Code>62559-0167-01</NDC11Code>
<ProductNDC>62559-167</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205177</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Capsules are an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. : 1 Limitations of UseBecause of the risks of addiction, abuse, and misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including Oxycodone Hydrochloride Capsules, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Capsules are an agonist, available as a hard gelatin capsule 5 mg for oral administration. The chemical name is (5R,9R,13S,14S)-4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C18H21NO4∙HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. It is soluble in water and slightly soluble in alcohol. The inactive ingredients in Oxycodone Hydrochloride Capsules 5 mg include: colloidal silicon dioxide, gelatin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, FD&C yellow #6, titanium dioxide, yellow iron oxide, shellac glaze, iron oxide black, propylene glycol, and ammonium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>62559-220-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (62559-220-01) </PackageDescription>
<NDC11Code>62559-0220-01</NDC11Code>
<ProductNDC>62559-220</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxcarbazepine</ProprietaryName>
<NonProprietaryName>Oxcarbazepine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078005</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>OXCARBAZEPINE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxcarbazepine Tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.</IndicationAndUsage>
<Description>Oxcarbazepine Tablets USP are an AED available as 150 mg, 300 mg, and 600 mg film-coated tablets for oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo- 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is a white to faintly orange crystalline powder. It is slightly soluble in chloroform, dichloromethane, acetone, and methanol and practically insoluble in ethanol, ether and water. Its molecular weight is 252.27 g/mol. Oxcarbazepine Tablets USP contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide. Oxcarbazepine Tablets USP meet USP Organic Impurities Test 2.</Description>
</NDC>
<NDC>
<NDCCode>62559-220-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (62559-220-05) </PackageDescription>
<NDC11Code>62559-0220-05</NDC11Code>
<ProductNDC>62559-220</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxcarbazepine</ProprietaryName>
<NonProprietaryName>Oxcarbazepine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078005</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>OXCARBAZEPINE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxcarbazepine Tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.</IndicationAndUsage>
<Description>Oxcarbazepine Tablets USP are an AED available as 150 mg, 300 mg, and 600 mg film-coated tablets for oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo- 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. Oxcarbazepine is a white to faintly orange crystalline powder. It is slightly soluble in chloroform, dichloromethane, acetone, and methanol and practically insoluble in ethanol, ether and water. Its molecular weight is 252.27 g/mol. Oxcarbazepine Tablets USP contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide. Oxcarbazepine Tablets USP meet USP Organic Impurities Test 2.</Description>
</NDC>
</NDCList>