{
"NDC": [
{
"NDCCode": "59746-591-23",
"PackageDescription": "25 VIAL in 1 CARTON (59746-591-23) > 5 mL in 1 VIAL (59746-591-01) ",
"NDC11Code": "59746-0591-23",
"ProductNDC": "59746-591",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam Injection",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160602",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206838",
"LabelerName": "Jubilant Cadista Pharmaceuticals Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160602",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam injection is indicated for adjunctive therapy, as an alternative when oral administration is temporarily not feasible, in the treatment of: : 1 Partial onset seizures in patients 1 month of age and older with epilepsy (1.1) , 2 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) , 3 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
"Description": "Levetiracetam injection, USP is an antiepileptic drug available as a clear, colorless, sterile solution (100 mg/mL) for intravenous administration. The chemical name of levetiracetam, USP a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam, USP is a white to almost white crystalline powder. It is very soluble in water, soluble in Acetonitrile and practically insoluble in hexane.Levetiracetam injection, USP contains 100 mg of levetiracetam per mL. It is supplied in single-use 5 mL vials containing 500 mg levetiracetam, water for injection, 45 mg sodium chloride, and buffered at approximately pH 5.5 with glacial acetic acid and 8.2 mg sodium acetate trihydrate. Levetiracetam injection, USP must be diluted prior to intravenous infusion [see Dosage and Administration (2.6)]."
},
{
"NDCCode": "59746-591-10",
"PackageDescription": "10 VIAL in 1 CARTON (59746-591-10) > 5 mL in 1 VIAL (59746-591-01) ",
"NDC11Code": "59746-0591-10",
"ProductNDC": "59746-591",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam Injection",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160602",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206838",
"LabelerName": "Jubilant Cadista Pharmaceuticals Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160602",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam injection is indicated for adjunctive therapy, as an alternative when oral administration is temporarily not feasible, in the treatment of: : 1 Partial onset seizures in patients 1 month of age and older with epilepsy (1.1) , 2 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) , 3 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
"Description": "Levetiracetam injection, USP is an antiepileptic drug available as a clear, colorless, sterile solution (100 mg/mL) for intravenous administration. The chemical name of levetiracetam, USP a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam, USP is a white to almost white crystalline powder. It is very soluble in water, soluble in Acetonitrile and practically insoluble in hexane.Levetiracetam injection, USP contains 100 mg of levetiracetam per mL. It is supplied in single-use 5 mL vials containing 500 mg levetiracetam, water for injection, 45 mg sodium chloride, and buffered at approximately pH 5.5 with glacial acetic acid and 8.2 mg sodium acetate trihydrate. Levetiracetam injection, USP must be diluted prior to intravenous infusion [see Dosage and Administration (2.6)]."
},
{
"NDCCode": "69423-591-23",
"PackageDescription": "236.5 mL in 1 BOTTLE, PLASTIC (69423-591-23) ",
"NDC11Code": "69423-0591-23",
"ProductNDC": "69423-591",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "First Aid Beauty Anti-dandruff",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210730",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "1",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210730",
"SamplePackage": "N",
"IndicationAndUsage": "helps eliminate and reduces recurrence of the symptoms of dandruff."
},
{
"NDCCode": "69842-591-23",
"PackageDescription": "20 TABLET in 1 BOTTLE (69842-591-23) ",
"NDC11Code": "69842-0591-23",
"ProductNDC": "69842-591",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen 250mg Aspirin 250mg Caffeine 65mg",
"NonProprietaryName": "Acetaminophen 250mg Aspirin 250mg Caffeine 65mg",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2025-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210201",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves minor aches and pains due to. Headache, a cold, arthritis, muscular aches, toothache, premenstrual and menstrual cramps."
},
{
"NDCCode": "31722-591-01",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-591-01) ",
"NDC11Code": "31722-0591-01",
"ProductNDC": "31722-591",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205541",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201106",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol succinate extended-release tablets, are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure ( 1.3) .",
"Description": "Metoprolol succinate, USP is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate, USP in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate, USP equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)-1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate, USP is a white to off white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in alcohol and slightly soluble in isopropyl alcohol. Inactive ingredients: acetyl tributyl citrate, crospovidone, ethylcellulose, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, methylene chloride, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicified microcrystalline cellulose, sodium stearyl fumarate and titanium dioxide. Colorcoat glow is used as a polishing agent."
},
{
"NDCCode": "31722-591-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-591-05) ",
"NDC11Code": "31722-0591-05",
"ProductNDC": "31722-591",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205541",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210423",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol succinate extended-release tablets, are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure ( 1.3) .",
"Description": "Metoprolol succinate, USP is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate, USP in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate, USP equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)-1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate, USP is a white to off white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in alcohol and slightly soluble in isopropyl alcohol. Inactive ingredients: acetyl tributyl citrate, crospovidone, ethylcellulose, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, methylene chloride, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicified microcrystalline cellulose, sodium stearyl fumarate and titanium dioxide. Colorcoat glow is used as a polishing agent."
},
{
"NDCCode": "31722-591-10",
"PackageDescription": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-591-10) ",
"NDC11Code": "31722-0591-10",
"ProductNDC": "31722-591",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205541",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210423",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol succinate extended-release tablets, are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure ( 1.3) .",
"Description": "Metoprolol succinate, USP is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate, USP in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate, USP equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)-1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate, USP is a white to off white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in alcohol and slightly soluble in isopropyl alcohol. Inactive ingredients: acetyl tributyl citrate, crospovidone, ethylcellulose, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, methylene chloride, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicified microcrystalline cellulose, sodium stearyl fumarate and titanium dioxide. Colorcoat glow is used as a polishing agent."
},
{
"NDCCode": "31722-591-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-591-30) ",
"NDC11Code": "31722-0591-30",
"ProductNDC": "31722-591",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205541",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201106",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol succinate extended-release tablets, are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure ( 1.3) .",
"Description": "Metoprolol succinate, USP is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate, USP in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate, USP equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)-1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate, USP is a white to off white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in alcohol and slightly soluble in isopropyl alcohol. Inactive ingredients: acetyl tributyl citrate, crospovidone, ethylcellulose, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, methylene chloride, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicified microcrystalline cellulose, sodium stearyl fumarate and titanium dioxide. Colorcoat glow is used as a polishing agent."
},
{
"NDCCode": "55289-591-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (55289-591-30) ",
"NDC11Code": "55289-0591-30",
"ProductNDC": "55289-591",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enalapril Maleate",
"NonProprietaryName": "Enalapril Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075483",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "ENALAPRIL MALEATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20160209",
"SamplePackage": "N"
},
{
"NDCCode": "55289-591-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (55289-591-90) ",
"NDC11Code": "55289-0591-90",
"ProductNDC": "55289-591",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enalapril Maleate",
"NonProprietaryName": "Enalapril Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075483",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "ENALAPRIL MALEATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20160209",
"SamplePackage": "N"
},
{
"NDCCode": "55301-591-32",
"PackageDescription": "32 TABLET, CHEWABLE in 1 BAG (55301-591-32) ",
"NDC11Code": "55301-0591-32",
"ProductNDC": "55301-591",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Exchange Select Antacid",
"ProprietaryNameSuffix": "Soft Chews Cherry Flavor",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20250903",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "Army & Air Force Exchange Service",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "1177",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250903",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms."
},
{
"NDCCode": "59555-401-12",
"PackageDescription": "591 mL in 1 BOTTLE, PUMP (59555-401-12) ",
"NDC11Code": "59555-0401-12",
"ProductNDC": "59555-401",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "I.c. Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140614",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "R&R Lotion, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140615",
"SamplePackage": "N",
"IndicationAndUsage": "For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "60760-591-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (60760-591-60) ",
"NDC11Code": "60760-0591-60",
"ProductNDC": "60760-591",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230519",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208677",
"LabelerName": "St. Mary's Medical Park Pharmacy",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230519",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for. Management of neuropathic pain associated with diabetic peripheral neuropathy. Management of postherpetic neuralgia. Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older. Management of fibromyalgia. Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline powder with a pK a1of 4.2 and a pK a2of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is - 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide and sodium lauryl sulfate. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain the colorants FD&C Blue 1, FD&C Red 40 and FD&C Yellow 6. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide."
},
{
"NDCCode": "67877-591-01",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-591-01) ",
"NDC11Code": "67877-0591-01",
"ProductNDC": "67877-591",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate Er Tablets",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211143",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201127",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of. Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1). Angina Pectoris. (1.2). Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure (1.3).",
"Description": "Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg, 47.5 mg, 95 mg and 190 mg of metoprolol succinate equivalent to 25 mg, 50 mg, 100 mg and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white or almost white, crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in Isopropyl alcohol; practically insoluble in ethyl-acetate. Inactive ingredients: Microcrystalline cellulose, Colloidal silicon dioxide, Povidone, Ethyl cellulose, Hypromellose, Methacrylic acid and ethyl acrylate copolymer dispersion, Triethyl citrate, Talc, Silicified Microcrystalline Cellulose, Polyethylene Glycol, Croscarmellose sodium, Sodium Stearyl Fumarate, Titanium dioxide. \"FDA approved dissolution testing specifications differ from USP\"."
},
{
"NDCCode": "67877-591-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-591-05) ",
"NDC11Code": "67877-0591-05",
"ProductNDC": "67877-591",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate Er Tablets",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211143",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201127",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of. Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1). Angina Pectoris. (1.2). Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure (1.3).",
"Description": "Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg, 47.5 mg, 95 mg and 190 mg of metoprolol succinate equivalent to 25 mg, 50 mg, 100 mg and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white or almost white, crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in Isopropyl alcohol; practically insoluble in ethyl-acetate. Inactive ingredients: Microcrystalline cellulose, Colloidal silicon dioxide, Povidone, Ethyl cellulose, Hypromellose, Methacrylic acid and ethyl acrylate copolymer dispersion, Triethyl citrate, Talc, Silicified Microcrystalline Cellulose, Polyethylene Glycol, Croscarmellose sodium, Sodium Stearyl Fumarate, Titanium dioxide. \"FDA approved dissolution testing specifications differ from USP\"."
},
{
"NDCCode": "67877-591-10",
"PackageDescription": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-591-10) ",
"NDC11Code": "67877-0591-10",
"ProductNDC": "67877-591",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate Er Tablets",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211143",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201127",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of. Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1). Angina Pectoris. (1.2). Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure (1.3).",
"Description": "Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg, 47.5 mg, 95 mg and 190 mg of metoprolol succinate equivalent to 25 mg, 50 mg, 100 mg and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white or almost white, crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in Isopropyl alcohol; practically insoluble in ethyl-acetate. Inactive ingredients: Microcrystalline cellulose, Colloidal silicon dioxide, Povidone, Ethyl cellulose, Hypromellose, Methacrylic acid and ethyl acrylate copolymer dispersion, Triethyl citrate, Talc, Silicified Microcrystalline Cellulose, Polyethylene Glycol, Croscarmellose sodium, Sodium Stearyl Fumarate, Titanium dioxide. \"FDA approved dissolution testing specifications differ from USP\"."
},
{
"NDCCode": "67877-591-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-591-30) ",
"NDC11Code": "67877-0591-30",
"ProductNDC": "67877-591",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate Er Tablets",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211143",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201127",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of. Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1). Angina Pectoris. (1.2). Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure (1.3).",
"Description": "Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg, 47.5 mg, 95 mg and 190 mg of metoprolol succinate equivalent to 25 mg, 50 mg, 100 mg and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white or almost white, crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in Isopropyl alcohol; practically insoluble in ethyl-acetate. Inactive ingredients: Microcrystalline cellulose, Colloidal silicon dioxide, Povidone, Ethyl cellulose, Hypromellose, Methacrylic acid and ethyl acrylate copolymer dispersion, Triethyl citrate, Talc, Silicified Microcrystalline Cellulose, Polyethylene Glycol, Croscarmellose sodium, Sodium Stearyl Fumarate, Titanium dioxide. \"FDA approved dissolution testing specifications differ from USP\"."
},
{
"NDCCode": "67877-591-60",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-591-60) ",
"NDC11Code": "67877-0591-60",
"ProductNDC": "67877-591",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate Er Tablets",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211143",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201127",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of. Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1). Angina Pectoris. (1.2). Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure (1.3).",
"Description": "Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg, 47.5 mg, 95 mg and 190 mg of metoprolol succinate equivalent to 25 mg, 50 mg, 100 mg and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white or almost white, crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in Isopropyl alcohol; practically insoluble in ethyl-acetate. Inactive ingredients: Microcrystalline cellulose, Colloidal silicon dioxide, Povidone, Ethyl cellulose, Hypromellose, Methacrylic acid and ethyl acrylate copolymer dispersion, Triethyl citrate, Talc, Silicified Microcrystalline Cellulose, Polyethylene Glycol, Croscarmellose sodium, Sodium Stearyl Fumarate, Titanium dioxide. \"FDA approved dissolution testing specifications differ from USP\"."
},
{
"NDCCode": "73126-032-06",
"PackageDescription": "591 mL in 1 PACKAGE (73126-032-06) ",
"NDC11Code": "73126-0032-06",
"ProductNDC": "73126-032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Truth Antibacterial Foaming Hand Wash - Unscented",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210304",
"EndMarketingDate": "20240420",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "LAB-CLEAN, INC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-04-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210304",
"EndMarketingDatePackage": "20240420",
"SamplePackage": "N",
"IndicationAndUsage": "For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "73126-033-06",
"PackageDescription": "591 mL in 1 PACKAGE (73126-033-06) ",
"NDC11Code": "73126-0033-06",
"ProductNDC": "73126-033",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Truth Alcohol Free Hand Sanitizer - Lavender Eucalyptus",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210304",
"EndMarketingDate": "20240420",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "LAB-CLEAN, INC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-04-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210304",
"EndMarketingDatePackage": "20240420",
"SamplePackage": "N",
"IndicationAndUsage": "For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "73126-034-06",
"PackageDescription": "591 mL in 1 PACKAGE (73126-034-06) ",
"NDC11Code": "73126-0034-06",
"ProductNDC": "73126-034",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Truth Alcohol Free Hand Sanitizer - Unscented",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210304",
"EndMarketingDate": "20240420",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "LAB-CLEAN, INC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-04-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210304",
"EndMarketingDatePackage": "20240420",
"SamplePackage": "N",
"IndicationAndUsage": "For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "59746-789-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59746-789-01) ",
"NDC11Code": "59746-0789-01",
"ProductNDC": "59746-789",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbamazepine",
"NonProprietaryName": "Carbamazepine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220820",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216594",
"LabelerName": "Jubilant Cadista Pharmaceuticals Inc.",
"SubstanceName": "CARBAMAZEPINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220820",
"SamplePackage": "N",
"IndicationAndUsage": "Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types. 1. Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. 2. Generalized tonic-clonic seizures (grand mal). 3. Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General).",
"Description": "Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as extended-release tablets of 100 mg, 200 mg and 400 mg. Its chemical name is 5 H-dibenz[ b,f]azepine-5-carboxamide, and its structural formula is:. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27 g/mol. Inactive Ingredients: Microcrystalline cellulose, Hypromellose, Ethyl acrylate and Methyl methacrylate copolymer dispersion, Croscarmellose sodium, Talc, Ethyl cellulose aqueous dispersion, Colloidal silicon dioxide, Magnesium stearate and Instacoat universal peach. Meets USP Dissolution Test 6."
},
{
"NDCCode": "59746-790-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59746-790-01) ",
"NDC11Code": "59746-0790-01",
"ProductNDC": "59746-790",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbamazepine",
"NonProprietaryName": "Carbamazepine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220820",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216594",
"LabelerName": "Jubilant Cadista Pharmaceuticals Inc.",
"SubstanceName": "CARBAMAZEPINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220820",
"SamplePackage": "N",
"IndicationAndUsage": "Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types. 1. Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. 2. Generalized tonic-clonic seizures (grand mal). 3. Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General).",
"Description": "Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as extended-release tablets of 100 mg, 200 mg and 400 mg. Its chemical name is 5 H-dibenz[ b,f]azepine-5-carboxamide, and its structural formula is:. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27 g/mol. Inactive Ingredients: Microcrystalline cellulose, Hypromellose, Ethyl acrylate and Methyl methacrylate copolymer dispersion, Croscarmellose sodium, Talc, Ethyl cellulose aqueous dispersion, Colloidal silicon dioxide, Magnesium stearate and Instacoat universal peach. Meets USP Dissolution Test 6."
},
{
"NDCCode": "59746-791-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59746-791-01) ",
"NDC11Code": "59746-0791-01",
"ProductNDC": "59746-791",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbamazepine",
"NonProprietaryName": "Carbamazepine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220820",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216594",
"LabelerName": "Jubilant Cadista Pharmaceuticals Inc.",
"SubstanceName": "CARBAMAZEPINE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220820",
"SamplePackage": "N",
"IndicationAndUsage": "Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types. 1. Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. 2. Generalized tonic-clonic seizures (grand mal). 3. Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General).",
"Description": "Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as extended-release tablets of 100 mg, 200 mg and 400 mg. Its chemical name is 5 H-dibenz[ b,f]azepine-5-carboxamide, and its structural formula is:. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27 g/mol. Inactive Ingredients: Microcrystalline cellulose, Hypromellose, Ethyl acrylate and Methyl methacrylate copolymer dispersion, Croscarmellose sodium, Talc, Ethyl cellulose aqueous dispersion, Colloidal silicon dioxide, Magnesium stearate and Instacoat universal peach. Meets USP Dissolution Test 6."
},
{
"NDCCode": "59746-798-01",
"PackageDescription": "100 CAPSULE, GELATIN COATED in 1 BOTTLE (59746-798-01) ",
"NDC11Code": "59746-0798-01",
"ProductNDC": "59746-798",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20241130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090802",
"LabelerName": "Jubilant Cadista Pharmaceuticals Inc.",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241130",
"SamplePackage": "N",
"IndicationAndUsage": "Tacrolimus Capsules USP is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart, or lung transplants, in combination with other immunosuppressants. (1.1).",
"Description": "Tacrolimus, previously known as FK506, is the active ingredient in Tacrolimus Capsules USP. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S [3R*[E(1S*, 3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus USP is. Tacrolimus USP has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus appears as white to off white powder. It is soluble in acetone, chloroform, ethyl acetate and insoluble in water. Tacrolimus Capsules USP is available for oral administration as capsules (tacrolimus capsules) containing the equivalent of 0.5 mg, 1 mg or 5 mg of tacrolimus USP. Inactive ingredients include croscarmellose sodium NF, hypromellose USP, lactose anhydrous USNF, and magnesium stearate USNF. The 0.5 mg capsule shell contains ferric oxide, gelatin and titanium dioxide. The 1 mg capsule shell contains gelatin and titanium dioxide. The 5 mg capsule shell contains ferric oxide, gelatin, and titanium dioxide."
},
{
"NDCCode": "59746-799-01",
"PackageDescription": "100 CAPSULE, GELATIN COATED in 1 BOTTLE (59746-799-01) ",
"NDC11Code": "59746-0799-01",
"ProductNDC": "59746-799",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20241130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090802",
"LabelerName": "Jubilant Cadista Pharmaceuticals Inc.",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20241130",
"SamplePackage": "N",
"IndicationAndUsage": "Tacrolimus Capsules USP is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart, or lung transplants, in combination with other immunosuppressants. (1.1).",
"Description": "Tacrolimus, previously known as FK506, is the active ingredient in Tacrolimus Capsules USP. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S [3R*[E(1S*, 3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus USP is. Tacrolimus USP has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus appears as white to off white powder. It is soluble in acetone, chloroform, ethyl acetate and insoluble in water. Tacrolimus Capsules USP is available for oral administration as capsules (tacrolimus capsules) containing the equivalent of 0.5 mg, 1 mg or 5 mg of tacrolimus USP. Inactive ingredients include croscarmellose sodium NF, hypromellose USP, lactose anhydrous USNF, and magnesium stearate USNF. The 0.5 mg capsule shell contains ferric oxide, gelatin and titanium dioxide. The 1 mg capsule shell contains gelatin and titanium dioxide. The 5 mg capsule shell contains ferric oxide, gelatin, and titanium dioxide."
},
{
"NDCCode": "59746-800-01",
"PackageDescription": "100 CAPSULE, GELATIN COATED in 1 BOTTLE (59746-800-01) ",
"NDC11Code": "59746-0800-01",
"ProductNDC": "59746-800",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20241130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090802",
"LabelerName": "Jubilant Cadista Pharmaceuticals Inc.",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
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"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20241130",
"SamplePackage": "N",
"IndicationAndUsage": "Tacrolimus Capsules USP is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart, or lung transplants, in combination with other immunosuppressants. (1.1).",
"Description": "Tacrolimus, previously known as FK506, is the active ingredient in Tacrolimus Capsules USP. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S [3R*[E(1S*, 3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus USP is. Tacrolimus USP has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus appears as white to off white powder. It is soluble in acetone, chloroform, ethyl acetate and insoluble in water. Tacrolimus Capsules USP is available for oral administration as capsules (tacrolimus capsules) containing the equivalent of 0.5 mg, 1 mg or 5 mg of tacrolimus USP. Inactive ingredients include croscarmellose sodium NF, hypromellose USP, lactose anhydrous USNF, and magnesium stearate USNF. The 0.5 mg capsule shell contains ferric oxide, gelatin and titanium dioxide. The 1 mg capsule shell contains gelatin and titanium dioxide. The 5 mg capsule shell contains ferric oxide, gelatin, and titanium dioxide."
},
{
"NDCCode": "0143-9529-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 BOX (0143-9529-01) / 5 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00143-9529-01",
"ProductNDC": "0143-9529",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluphenazine Decanoate",
"NonProprietaryName": "Fluphenazine Decanoate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
"StartMarketingDate": "19960830",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074531",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "FLUPHENAZINE DECANOATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19960830",
"SamplePackage": "N",
"IndicationAndUsage": "Fluphenazine Decanoate Injection, USP is a long-acting parenteral antipsychotic drug intended for use in the management of patients requiring prolonged parenteral neuroleptic therapy (e.g., chronic schizophrenics). Fluphenazine Decanoate Injection, USP has not been shown effective in the management of behavioral complications in patients with mental retardation.",
"Description": "Fluphenazine decanoate is the decanoate ester of a trifluoromethyl phenothiazine derivative. It is a highly potent behavior modifier with a markedly extended duration of effect. Fluphenazine Decanoate Injection, USP is a sterile injection, available for intramuscular or subcutaneous administration, providing 25 mg fluphenazine decanoate per mL in a sesame oil vehicle with 1.2% (w/v) benzyl alcohol as a preservative. At the time of manufacture, the air in the vials is replaced by nitrogen. The chemical name of fluphenazine decanoate is 4-[3-[2-(Trifluoromethyl)-10H-phenothiazin-10-yl]propyl]-1-piperazineethanol decanoate. It has the following structural formula. Molecular Formula = C32H44F3N3O2S M.W.= 591.78."
},
{
"NDCCode": "0299-4121-00",
"PackageDescription": "591 mL in 1 BOTTLE (0299-4121-00) ",
"NDC11Code": "00299-4121-00",
"ProductNDC": "0299-4121",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetaphil Acne Relief Body Wash",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "Galderma Laboratories, L.P.",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "N",
"IndicationAndUsage": "For the management of acne."
},
{
"NDCCode": "10202-591-90",
"PackageDescription": "1 BOTTLE in 1 BLISTER PACK (10202-591-90) > 1 mL in 1 BOTTLE",
"NDC11Code": "10202-0591-90",
"ProductNDC": "10202-591",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "7 Select Cold Sore Symptom Treatment",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160603",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "7-eleven",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160603",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: Treats cold sores/fever blisters. For the pain, tingling, itching, & burning associated with cold sores. May be used as an antiseptic to help cleanse or dry sores & fever blisters. May be used inside the mouth on sores."
}
]
}
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<NDC>
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<PackageDescription>25 VIAL in 1 CARTON (59746-591-23) > 5 mL in 1 VIAL (59746-591-01) </PackageDescription>
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<ProductNDC>59746-591</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
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<LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
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<IndicationAndUsage>Levetiracetam injection is indicated for adjunctive therapy, as an alternative when oral administration is temporarily not feasible, in the treatment of: : 1 Partial onset seizures in patients 1 month of age and older with epilepsy (1.1) , 2 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) , 3 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
<Description>Levetiracetam injection, USP is an antiepileptic drug available as a clear, colorless, sterile solution (100 mg/mL) for intravenous administration. The chemical name of levetiracetam, USP a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam, USP is a white to almost white crystalline powder. It is very soluble in water, soluble in Acetonitrile and practically insoluble in hexane.Levetiracetam injection, USP contains 100 mg of levetiracetam per mL. It is supplied in single-use 5 mL vials containing 500 mg levetiracetam, water for injection, 45 mg sodium chloride, and buffered at approximately pH 5.5 with glacial acetic acid and 8.2 mg sodium acetate trihydrate. Levetiracetam injection, USP must be diluted prior to intravenous infusion [see Dosage and Administration (2.6)].</Description>
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<PackageDescription>10 VIAL in 1 CARTON (59746-591-10) > 5 mL in 1 VIAL (59746-591-01) </PackageDescription>
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<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam injection is indicated for adjunctive therapy, as an alternative when oral administration is temporarily not feasible, in the treatment of: : 1 Partial onset seizures in patients 1 month of age and older with epilepsy (1.1) , 2 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) , 3 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
<Description>Levetiracetam injection, USP is an antiepileptic drug available as a clear, colorless, sterile solution (100 mg/mL) for intravenous administration. The chemical name of levetiracetam, USP a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam, USP is a white to almost white crystalline powder. It is very soluble in water, soluble in Acetonitrile and practically insoluble in hexane.Levetiracetam injection, USP contains 100 mg of levetiracetam per mL. It is supplied in single-use 5 mL vials containing 500 mg levetiracetam, water for injection, 45 mg sodium chloride, and buffered at approximately pH 5.5 with glacial acetic acid and 8.2 mg sodium acetate trihydrate. Levetiracetam injection, USP must be diluted prior to intravenous infusion [see Dosage and Administration (2.6)].</Description>
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<NDCCode>69423-591-23</NDCCode>
<PackageDescription>236.5 mL in 1 BOTTLE, PLASTIC (69423-591-23) </PackageDescription>
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<ProprietaryName>First Aid Beauty Anti-dandruff</ProprietaryName>
<NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210730</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>PYRITHIONE ZINC</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210730</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps eliminate and reduces recurrence of the symptoms of dandruff.</IndicationAndUsage>
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<NDC>
<NDCCode>69842-591-23</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (69842-591-23) </PackageDescription>
<NDC11Code>69842-0591-23</NDC11Code>
<ProductNDC>69842-591</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen 250mg Aspirin 250mg Caffeine 65mg</ProprietaryName>
<NonProprietaryName>Acetaminophen 250mg Aspirin 250mg Caffeine 65mg</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves minor aches and pains due to. Headache, a cold, arthritis, muscular aches, toothache, premenstrual and menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
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<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-591-01) </PackageDescription>
<NDC11Code>31722-0591-01</NDC11Code>
<ProductNDC>31722-591</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201106</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol succinate extended-release tablets, are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure ( 1.3) .</IndicationAndUsage>
<Description>Metoprolol succinate, USP is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate, USP in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate, USP equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)-1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate, USP is a white to off white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in alcohol and slightly soluble in isopropyl alcohol. Inactive ingredients: acetyl tributyl citrate, crospovidone, ethylcellulose, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, methylene chloride, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicified microcrystalline cellulose, sodium stearyl fumarate and titanium dioxide. Colorcoat glow is used as a polishing agent.</Description>
</NDC>
<NDC>
<NDCCode>31722-591-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-591-05) </PackageDescription>
<NDC11Code>31722-0591-05</NDC11Code>
<ProductNDC>31722-591</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201106</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205541</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210423</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol succinate extended-release tablets, are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure ( 1.3) .</IndicationAndUsage>
<Description>Metoprolol succinate, USP is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate, USP in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate, USP equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)-1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate, USP is a white to off white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in alcohol and slightly soluble in isopropyl alcohol. Inactive ingredients: acetyl tributyl citrate, crospovidone, ethylcellulose, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, methylene chloride, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicified microcrystalline cellulose, sodium stearyl fumarate and titanium dioxide. Colorcoat glow is used as a polishing agent.</Description>
</NDC>
<NDC>
<NDCCode>31722-591-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-591-10) </PackageDescription>
<NDC11Code>31722-0591-10</NDC11Code>
<ProductNDC>31722-591</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201106</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205541</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210423</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol succinate extended-release tablets, are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure ( 1.3) .</IndicationAndUsage>
<Description>Metoprolol succinate, USP is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate, USP in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate, USP equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)-1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate, USP is a white to off white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in alcohol and slightly soluble in isopropyl alcohol. Inactive ingredients: acetyl tributyl citrate, crospovidone, ethylcellulose, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, methylene chloride, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicified microcrystalline cellulose, sodium stearyl fumarate and titanium dioxide. Colorcoat glow is used as a polishing agent.</Description>
</NDC>
<NDC>
<NDCCode>31722-591-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-591-30) </PackageDescription>
<NDC11Code>31722-0591-30</NDC11Code>
<ProductNDC>31722-591</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201106</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205541</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol succinate extended-release tablets, are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure ( 1.3) .</IndicationAndUsage>
<Description>Metoprolol succinate, USP is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate, USP in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate, USP equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)-1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate, USP is a white to off white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in alcohol and slightly soluble in isopropyl alcohol. Inactive ingredients: acetyl tributyl citrate, crospovidone, ethylcellulose, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, methylene chloride, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicified microcrystalline cellulose, sodium stearyl fumarate and titanium dioxide. Colorcoat glow is used as a polishing agent.</Description>
</NDC>
<NDC>
<NDCCode>55289-591-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (55289-591-30) </PackageDescription>
<NDC11Code>55289-0591-30</NDC11Code>
<ProductNDC>55289-591</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enalapril Maleate</ProprietaryName>
<NonProprietaryName>Enalapril Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075483</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ENALAPRIL MALEATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55289-591-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (55289-591-90) </PackageDescription>
<NDC11Code>55289-0591-90</NDC11Code>
<ProductNDC>55289-591</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enalapril Maleate</ProprietaryName>
<NonProprietaryName>Enalapril Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075483</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ENALAPRIL MALEATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55301-591-32</NDCCode>
<PackageDescription>32 TABLET, CHEWABLE in 1 BAG (55301-591-32) </PackageDescription>
<NDC11Code>55301-0591-32</NDC11Code>
<ProductNDC>55301-591</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Exchange Select Antacid</ProprietaryName>
<ProprietaryNameSuffix>Soft Chews Cherry Flavor</ProprietaryNameSuffix>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250903</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>Army & Air Force Exchange Service</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>1177</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250903</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59555-401-12</NDCCode>
<PackageDescription>591 mL in 1 BOTTLE, PUMP (59555-401-12) </PackageDescription>
<NDC11Code>59555-0401-12</NDC11Code>
<ProductNDC>59555-401</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>I.c. Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140614</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>R&R Lotion, Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>60760-591-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (60760-591-60) </PackageDescription>
<NDC11Code>60760-0591-60</NDC11Code>
<ProductNDC>60760-591</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230519</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208677</ApplicationNumber>
<LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230519</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for. Management of neuropathic pain associated with diabetic peripheral neuropathy. Management of postherpetic neuralgia. Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older. Management of fibromyalgia. Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline powder with a pK a1of 4.2 and a pK a2of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is - 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide and sodium lauryl sulfate. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain the colorants FD&C Blue 1, FD&C Red 40 and FD&C Yellow 6. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>67877-591-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-591-01) </PackageDescription>
<NDC11Code>67877-0591-01</NDC11Code>
<ProductNDC>67877-591</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate Er Tablets</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211143</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of. Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1). Angina Pectoris. (1.2). Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure (1.3).</IndicationAndUsage>
<Description>Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg, 47.5 mg, 95 mg and 190 mg of metoprolol succinate equivalent to 25 mg, 50 mg, 100 mg and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white or almost white, crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in Isopropyl alcohol; practically insoluble in ethyl-acetate. Inactive ingredients: Microcrystalline cellulose, Colloidal silicon dioxide, Povidone, Ethyl cellulose, Hypromellose, Methacrylic acid and ethyl acrylate copolymer dispersion, Triethyl citrate, Talc, Silicified Microcrystalline Cellulose, Polyethylene Glycol, Croscarmellose sodium, Sodium Stearyl Fumarate, Titanium dioxide. "FDA approved dissolution testing specifications differ from USP".</Description>
</NDC>
<NDC>
<NDCCode>67877-591-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-591-05) </PackageDescription>
<NDC11Code>67877-0591-05</NDC11Code>
<ProductNDC>67877-591</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate Er Tablets</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211143</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of. Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1). Angina Pectoris. (1.2). Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure (1.3).</IndicationAndUsage>
<Description>Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg, 47.5 mg, 95 mg and 190 mg of metoprolol succinate equivalent to 25 mg, 50 mg, 100 mg and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white or almost white, crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in Isopropyl alcohol; practically insoluble in ethyl-acetate. Inactive ingredients: Microcrystalline cellulose, Colloidal silicon dioxide, Povidone, Ethyl cellulose, Hypromellose, Methacrylic acid and ethyl acrylate copolymer dispersion, Triethyl citrate, Talc, Silicified Microcrystalline Cellulose, Polyethylene Glycol, Croscarmellose sodium, Sodium Stearyl Fumarate, Titanium dioxide. "FDA approved dissolution testing specifications differ from USP".</Description>
</NDC>
<NDC>
<NDCCode>67877-591-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-591-10) </PackageDescription>
<NDC11Code>67877-0591-10</NDC11Code>
<ProductNDC>67877-591</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate Er Tablets</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211143</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of. Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1). Angina Pectoris. (1.2). Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure (1.3).</IndicationAndUsage>
<Description>Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg, 47.5 mg, 95 mg and 190 mg of metoprolol succinate equivalent to 25 mg, 50 mg, 100 mg and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white or almost white, crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in Isopropyl alcohol; practically insoluble in ethyl-acetate. Inactive ingredients: Microcrystalline cellulose, Colloidal silicon dioxide, Povidone, Ethyl cellulose, Hypromellose, Methacrylic acid and ethyl acrylate copolymer dispersion, Triethyl citrate, Talc, Silicified Microcrystalline Cellulose, Polyethylene Glycol, Croscarmellose sodium, Sodium Stearyl Fumarate, Titanium dioxide. "FDA approved dissolution testing specifications differ from USP".</Description>
</NDC>
<NDC>
<NDCCode>67877-591-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-591-30) </PackageDescription>
<NDC11Code>67877-0591-30</NDC11Code>
<ProductNDC>67877-591</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate Er Tablets</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211143</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of. Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1). Angina Pectoris. (1.2). Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure (1.3).</IndicationAndUsage>
<Description>Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg, 47.5 mg, 95 mg and 190 mg of metoprolol succinate equivalent to 25 mg, 50 mg, 100 mg and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white or almost white, crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in Isopropyl alcohol; practically insoluble in ethyl-acetate. Inactive ingredients: Microcrystalline cellulose, Colloidal silicon dioxide, Povidone, Ethyl cellulose, Hypromellose, Methacrylic acid and ethyl acrylate copolymer dispersion, Triethyl citrate, Talc, Silicified Microcrystalline Cellulose, Polyethylene Glycol, Croscarmellose sodium, Sodium Stearyl Fumarate, Titanium dioxide. "FDA approved dissolution testing specifications differ from USP".</Description>
</NDC>
<NDC>
<NDCCode>67877-591-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-591-60) </PackageDescription>
<NDC11Code>67877-0591-60</NDC11Code>
<ProductNDC>67877-591</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate Er Tablets</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211143</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of. Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1). Angina Pectoris. (1.2). Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure (1.3).</IndicationAndUsage>
<Description>Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg, 47.5 mg, 95 mg and 190 mg of metoprolol succinate equivalent to 25 mg, 50 mg, 100 mg and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white or almost white, crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in Isopropyl alcohol; practically insoluble in ethyl-acetate. Inactive ingredients: Microcrystalline cellulose, Colloidal silicon dioxide, Povidone, Ethyl cellulose, Hypromellose, Methacrylic acid and ethyl acrylate copolymer dispersion, Triethyl citrate, Talc, Silicified Microcrystalline Cellulose, Polyethylene Glycol, Croscarmellose sodium, Sodium Stearyl Fumarate, Titanium dioxide. "FDA approved dissolution testing specifications differ from USP".</Description>
</NDC>
<NDC>
<NDCCode>73126-032-06</NDCCode>
<PackageDescription>591 mL in 1 PACKAGE (73126-032-06) </PackageDescription>
<NDC11Code>73126-0032-06</NDC11Code>
<ProductNDC>73126-032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Truth Antibacterial Foaming Hand Wash - Unscented</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210304</StartMarketingDate>
<EndMarketingDate>20240420</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>LAB-CLEAN, INC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-04-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210304</StartMarketingDatePackage>
<EndMarketingDatePackage>20240420</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73126-033-06</NDCCode>
<PackageDescription>591 mL in 1 PACKAGE (73126-033-06) </PackageDescription>
<NDC11Code>73126-0033-06</NDC11Code>
<ProductNDC>73126-033</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Truth Alcohol Free Hand Sanitizer - Lavender Eucalyptus</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210304</StartMarketingDate>
<EndMarketingDate>20240420</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>LAB-CLEAN, INC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-04-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210304</StartMarketingDatePackage>
<EndMarketingDatePackage>20240420</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73126-034-06</NDCCode>
<PackageDescription>591 mL in 1 PACKAGE (73126-034-06) </PackageDescription>
<NDC11Code>73126-0034-06</NDC11Code>
<ProductNDC>73126-034</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Truth Alcohol Free Hand Sanitizer - Unscented</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210304</StartMarketingDate>
<EndMarketingDate>20240420</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>LAB-CLEAN, INC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-04-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210304</StartMarketingDatePackage>
<EndMarketingDatePackage>20240420</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59746-789-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59746-789-01) </PackageDescription>
<NDC11Code>59746-0789-01</NDC11Code>
<ProductNDC>59746-789</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbamazepine</ProprietaryName>
<NonProprietaryName>Carbamazepine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220820</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216594</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CARBAMAZEPINE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types. 1. Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. 2. Generalized tonic-clonic seizures (grand mal). 3. Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General).</IndicationAndUsage>
<Description>Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as extended-release tablets of 100 mg, 200 mg and 400 mg. Its chemical name is 5 H-dibenz[ b,f]azepine-5-carboxamide, and its structural formula is:. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27 g/mol. Inactive Ingredients: Microcrystalline cellulose, Hypromellose, Ethyl acrylate and Methyl methacrylate copolymer dispersion, Croscarmellose sodium, Talc, Ethyl cellulose aqueous dispersion, Colloidal silicon dioxide, Magnesium stearate and Instacoat universal peach. Meets USP Dissolution Test 6.</Description>
</NDC>
<NDC>
<NDCCode>59746-790-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59746-790-01) </PackageDescription>
<NDC11Code>59746-0790-01</NDC11Code>
<ProductNDC>59746-790</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbamazepine</ProprietaryName>
<NonProprietaryName>Carbamazepine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220820</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216594</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CARBAMAZEPINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types. 1. Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. 2. Generalized tonic-clonic seizures (grand mal). 3. Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General).</IndicationAndUsage>
<Description>Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as extended-release tablets of 100 mg, 200 mg and 400 mg. Its chemical name is 5 H-dibenz[ b,f]azepine-5-carboxamide, and its structural formula is:. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27 g/mol. Inactive Ingredients: Microcrystalline cellulose, Hypromellose, Ethyl acrylate and Methyl methacrylate copolymer dispersion, Croscarmellose sodium, Talc, Ethyl cellulose aqueous dispersion, Colloidal silicon dioxide, Magnesium stearate and Instacoat universal peach. Meets USP Dissolution Test 6.</Description>
</NDC>
<NDC>
<NDCCode>59746-791-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59746-791-01) </PackageDescription>
<NDC11Code>59746-0791-01</NDC11Code>
<ProductNDC>59746-791</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbamazepine</ProprietaryName>
<NonProprietaryName>Carbamazepine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220820</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216594</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CARBAMAZEPINE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types. 1. Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. 2. Generalized tonic-clonic seizures (grand mal). 3. Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General).</IndicationAndUsage>
<Description>Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as extended-release tablets of 100 mg, 200 mg and 400 mg. Its chemical name is 5 H-dibenz[ b,f]azepine-5-carboxamide, and its structural formula is:. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27 g/mol. Inactive Ingredients: Microcrystalline cellulose, Hypromellose, Ethyl acrylate and Methyl methacrylate copolymer dispersion, Croscarmellose sodium, Talc, Ethyl cellulose aqueous dispersion, Colloidal silicon dioxide, Magnesium stearate and Instacoat universal peach. Meets USP Dissolution Test 6.</Description>
</NDC>
<NDC>
<NDCCode>59746-798-01</NDCCode>
<PackageDescription>100 CAPSULE, GELATIN COATED in 1 BOTTLE (59746-798-01) </PackageDescription>
<NDC11Code>59746-0798-01</NDC11Code>
<ProductNDC>59746-798</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090802</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tacrolimus Capsules USP is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart, or lung transplants, in combination with other immunosuppressants. (1.1).</IndicationAndUsage>
<Description>Tacrolimus, previously known as FK506, is the active ingredient in Tacrolimus Capsules USP. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S [3R*[E(1S*, 3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus USP is. Tacrolimus USP has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus appears as white to off white powder. It is soluble in acetone, chloroform, ethyl acetate and insoluble in water. Tacrolimus Capsules USP is available for oral administration as capsules (tacrolimus capsules) containing the equivalent of 0.5 mg, 1 mg or 5 mg of tacrolimus USP. Inactive ingredients include croscarmellose sodium NF, hypromellose USP, lactose anhydrous USNF, and magnesium stearate USNF. The 0.5 mg capsule shell contains ferric oxide, gelatin and titanium dioxide. The 1 mg capsule shell contains gelatin and titanium dioxide. The 5 mg capsule shell contains ferric oxide, gelatin, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>59746-799-01</NDCCode>
<PackageDescription>100 CAPSULE, GELATIN COATED in 1 BOTTLE (59746-799-01) </PackageDescription>
<NDC11Code>59746-0799-01</NDC11Code>
<ProductNDC>59746-799</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090802</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tacrolimus Capsules USP is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart, or lung transplants, in combination with other immunosuppressants. (1.1).</IndicationAndUsage>
<Description>Tacrolimus, previously known as FK506, is the active ingredient in Tacrolimus Capsules USP. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S [3R*[E(1S*, 3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus USP is. Tacrolimus USP has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus appears as white to off white powder. It is soluble in acetone, chloroform, ethyl acetate and insoluble in water. Tacrolimus Capsules USP is available for oral administration as capsules (tacrolimus capsules) containing the equivalent of 0.5 mg, 1 mg or 5 mg of tacrolimus USP. Inactive ingredients include croscarmellose sodium NF, hypromellose USP, lactose anhydrous USNF, and magnesium stearate USNF. The 0.5 mg capsule shell contains ferric oxide, gelatin and titanium dioxide. The 1 mg capsule shell contains gelatin and titanium dioxide. The 5 mg capsule shell contains ferric oxide, gelatin, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>59746-800-01</NDCCode>
<PackageDescription>100 CAPSULE, GELATIN COATED in 1 BOTTLE (59746-800-01) </PackageDescription>
<NDC11Code>59746-0800-01</NDC11Code>
<ProductNDC>59746-800</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090802</ApplicationNumber>
<LabelerName>Jubilant Cadista Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tacrolimus Capsules USP is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart, or lung transplants, in combination with other immunosuppressants. (1.1).</IndicationAndUsage>
<Description>Tacrolimus, previously known as FK506, is the active ingredient in Tacrolimus Capsules USP. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S [3R*[E(1S*, 3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus USP is. Tacrolimus USP has an empirical formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus appears as white to off white powder. It is soluble in acetone, chloroform, ethyl acetate and insoluble in water. Tacrolimus Capsules USP is available for oral administration as capsules (tacrolimus capsules) containing the equivalent of 0.5 mg, 1 mg or 5 mg of tacrolimus USP. Inactive ingredients include croscarmellose sodium NF, hypromellose USP, lactose anhydrous USNF, and magnesium stearate USNF. The 0.5 mg capsule shell contains ferric oxide, gelatin and titanium dioxide. The 1 mg capsule shell contains gelatin and titanium dioxide. The 5 mg capsule shell contains ferric oxide, gelatin, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0143-9529-01</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 BOX (0143-9529-01) / 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00143-9529-01</NDC11Code>
<ProductNDC>0143-9529</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluphenazine Decanoate</ProprietaryName>
<NonProprietaryName>Fluphenazine Decanoate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19960830</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074531</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>FLUPHENAZINE DECANOATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960830</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluphenazine Decanoate Injection, USP is a long-acting parenteral antipsychotic drug intended for use in the management of patients requiring prolonged parenteral neuroleptic therapy (e.g., chronic schizophrenics). Fluphenazine Decanoate Injection, USP has not been shown effective in the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
<Description>Fluphenazine decanoate is the decanoate ester of a trifluoromethyl phenothiazine derivative. It is a highly potent behavior modifier with a markedly extended duration of effect. Fluphenazine Decanoate Injection, USP is a sterile injection, available for intramuscular or subcutaneous administration, providing 25 mg fluphenazine decanoate per mL in a sesame oil vehicle with 1.2% (w/v) benzyl alcohol as a preservative. At the time of manufacture, the air in the vials is replaced by nitrogen. The chemical name of fluphenazine decanoate is 4-[3-[2-(Trifluoromethyl)-10H-phenothiazin-10-yl]propyl]-1-piperazineethanol decanoate. It has the following structural formula. Molecular Formula = C32H44F3N3O2S M.W.= 591.78.</Description>
</NDC>
<NDC>
<NDCCode>0299-4121-00</NDCCode>
<PackageDescription>591 mL in 1 BOTTLE (0299-4121-00) </PackageDescription>
<NDC11Code>00299-4121-00</NDC11Code>
<ProductNDC>0299-4121</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetaphil Acne Relief Body Wash</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>Galderma Laboratories, L.P.</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the management of acne.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10202-591-90</NDCCode>
<PackageDescription>1 BOTTLE in 1 BLISTER PACK (10202-591-90) > 1 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>10202-0591-90</NDC11Code>
<ProductNDC>10202-591</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>7 Select Cold Sore Symptom Treatment</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160603</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>7-eleven</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Treats cold sores/fever blisters. For the pain, tingling, itching, & burning associated with cold sores. May be used as an antiseptic to help cleanse or dry sores & fever blisters. May be used inside the mouth on sores.</IndicationAndUsage>
</NDC>
</NDCList>