{
"NDC": [
{
"NDCCode": "46994-511-23",
"PackageDescription": "700 mL in 1 BOTTLE, PLASTIC (46994-511-23)",
"NDC11Code": "46994-0511-23",
"ProductNDC": "46994-511",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Being Well Body",
"ProprietaryNameSuffix": "Dry Scalp Care",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130325",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358H",
"LabelerName": "Save-A-Lot Food Stores Ltd",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "1",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Uses helps eliminate irritation and flaking associated with dandruff."
},
{
"NDCCode": "46994-510-23",
"PackageDescription": "700 mL in 1 BOTTLE, PLASTIC (46994-510-23)",
"NDC11Code": "46994-0510-23",
"ProductNDC": "46994-510",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Being Well Body",
"ProprietaryNameSuffix": "2in1 Dandruff And Conditioner",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130325",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358H",
"LabelerName": "Save-A-Lot Food Stores Ltd",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "1",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Uses helps eliminate irritation and flaking associated with dandruff."
},
{
"NDCCode": "46994-511-14",
"PackageDescription": "420 mL in 1 BOTTLE, PLASTIC (46994-511-14)",
"NDC11Code": "46994-0511-14",
"ProductNDC": "46994-511",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Being Well Body",
"ProprietaryNameSuffix": "Dry Scalp Care",
"NonProprietaryName": "Pyrithione Zinc",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130325",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358H",
"LabelerName": "Save-A-Lot Food Stores Ltd",
"SubstanceName": "PYRITHIONE ZINC",
"StrengthNumber": "1",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Uses helps eliminate irritation and flaking associated with dandruff."
},
{
"NDCCode": "50157-511-23",
"PackageDescription": "236 mL in 1 BOTTLE, PLASTIC (50157-511-23) ",
"NDC11Code": "50157-0511-23",
"ProductNDC": "50157-511",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Moonlite Antibacterial",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200923",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Brands International Corporation",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200923",
"SamplePackage": "N",
"IndicationAndUsage": "Uses Effective in destorying(harmful) bacteria to provide antiseptic cleansing."
},
{
"NDCCode": "46994-175-12",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (46994-175-12) > 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "46994-0175-12",
"ProductNDC": "46994-175",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19930402",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "SAVE-A-LOT FOOD STORES, LTD.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2022-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19930402",
"SamplePackage": "N"
},
{
"NDCCode": "46994-568-50",
"PackageDescription": "710 mL in 1 BOTTLE, DISPENSING (46994-568-50) ",
"NDC11Code": "46994-0568-50",
"ProductNDC": "46994-568",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ultra Dish",
"NonProprietaryName": "Chloroxylenol 0.30%",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160711",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Save A Lot",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": "3.06",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20160711",
"SamplePackage": "N",
"IndicationAndUsage": "for handwashing to decrease bacteria on the skin."
},
{
"NDCCode": "0054-4496-13",
"PackageDescription": "30 TABLET in 1 BOTTLE (0054-4496-13) ",
"NDC11Code": "00054-4496-13",
"ProductNDC": "0054-4496",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Leucovorin Calcium",
"NonProprietaryName": "Leucovorin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19930222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072733",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "LEUCOVORIN CALCIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19930322",
"SamplePackage": "N",
"IndicationAndUsage": "Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5 Limitations of Use, 6 Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).",
"Description": "Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch."
},
{
"NDCCode": "0054-4496-25",
"PackageDescription": "100 TABLET in 1 BOTTLE (0054-4496-25) ",
"NDC11Code": "00054-4496-25",
"ProductNDC": "0054-4496",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Leucovorin Calcium",
"NonProprietaryName": "Leucovorin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19930222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072733",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "LEUCOVORIN CALCIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19930322",
"SamplePackage": "N",
"IndicationAndUsage": "Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5 Limitations of Use, 6 Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).",
"Description": "Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch."
},
{
"NDCCode": "0054-4497-05",
"PackageDescription": "12 TABLET in 1 BOTTLE (0054-4497-05) ",
"NDC11Code": "00054-4497-05",
"ProductNDC": "0054-4497",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Leucovorin Calcium",
"NonProprietaryName": "Leucovorin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19930222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072734",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "LEUCOVORIN CALCIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19930322",
"SamplePackage": "N",
"IndicationAndUsage": "Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5 Limitations of Use, 6 Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).",
"Description": "Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch."
},
{
"NDCCode": "0054-4497-10",
"PackageDescription": "24 TABLET in 1 BOTTLE (0054-4497-10) ",
"NDC11Code": "00054-4497-10",
"ProductNDC": "0054-4497",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Leucovorin Calcium",
"NonProprietaryName": "Leucovorin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19930222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072734",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "LEUCOVORIN CALCIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19930322",
"SamplePackage": "N",
"IndicationAndUsage": "Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5 Limitations of Use, 6 Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).",
"Description": "Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch."
},
{
"NDCCode": "0054-4498-10",
"PackageDescription": "24 TABLET in 1 BOTTLE (0054-4498-10) ",
"NDC11Code": "00054-4498-10",
"ProductNDC": "0054-4498",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Leucovorin Calcium",
"NonProprietaryName": "Leucovorin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19930222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072735",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "LEUCOVORIN CALCIUM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19930322",
"SamplePackage": "N",
"IndicationAndUsage": "Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5 Limitations of Use, 6 Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).",
"Description": "Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch."
},
{
"NDCCode": "0054-4499-11",
"PackageDescription": "25 TABLET in 1 BOTTLE (0054-4499-11) ",
"NDC11Code": "00054-4499-11",
"ProductNDC": "0054-4499",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Leucovorin Calcium",
"NonProprietaryName": "Leucovorin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19930222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072736",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "LEUCOVORIN CALCIUM",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19930322",
"SamplePackage": "N",
"IndicationAndUsage": "Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5 Limitations of Use, 6 Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).",
"Description": "Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch."
},
{
"NDCCode": "0054-8496-19",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (0054-8496-19) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "00054-8496-19",
"ProductNDC": "0054-8496",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Leucovorin Calcium",
"NonProprietaryName": "Leucovorin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19930222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072733",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "LEUCOVORIN CALCIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19930322",
"SamplePackage": "N",
"IndicationAndUsage": "Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5 Limitations of Use, 6 Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).",
"Description": "Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch."
},
{
"NDCCode": "43547-511-09",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (43547-511-09) ",
"NDC11Code": "43547-0511-09",
"ProductNDC": "43547-511",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207883",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200615",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for: : 1 Management of neuropathic pain associated with diabetic peripheral neuropathy , 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia , 5 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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 corn starch, lactose monohydrate, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the caramel capsule shells (25 mg, 50 mg, 75 mg, 150 mg, and 300 mg) contain red iron oxide and the light salmon capsule shells (225 mg) contain red iron oxide and yellow iron oxide. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac."
},
{
"NDCCode": "43547-511-50",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (43547-511-50) ",
"NDC11Code": "43547-0511-50",
"ProductNDC": "43547-511",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207883",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200615",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for: : 1 Management of neuropathic pain associated with diabetic peripheral neuropathy , 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia , 5 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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 corn starch, lactose monohydrate, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the caramel capsule shells (25 mg, 50 mg, 75 mg, 150 mg, and 300 mg) contain red iron oxide and the light salmon capsule shells (225 mg) contain red iron oxide and yellow iron oxide. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac."
},
{
"NDCCode": "50941-511-00",
"PackageDescription": "355 mL in 1 BOTTLE (50941-511-00) ",
"NDC11Code": "50941-0511-00",
"ProductNDC": "50941-511",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20230612",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "L Perrigo Company",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 200; 5",
"StrengthUnit": "mg/15mL; mg/15mL; mg/15mL; mg/15mL",
"Status": "Unfinished",
"LastUpdate": "2023-06-13",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "12-JUN-23"
},
{
"NDCCode": "57218-511-01",
"PackageDescription": "25 kg in 1 DRUM (57218-511-01) ",
"NDC11Code": "57218-0511-01",
"ProductNDC": "57218-511",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ephedrine Sulfate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20050101",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Malladi Drugs & Pharmaceuticals Limited",
"SubstanceName": "EPHEDRINE SULFATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-12-23",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "01-JAN-05"
},
{
"NDCCode": "63347-511-03",
"PackageDescription": "15 mL in 1 BOTTLE (63347-511-03) ",
"NDC11Code": "63347-0511-03",
"ProductNDC": "63347-511",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tineacide",
"NonProprietaryName": "Tolnaftate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120919",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M005",
"LabelerName": "Blaine Labs Inc.",
"SubstanceName": "TOLNAFTATE",
"StrengthNumber": "140",
"StrengthUnit": "mg/15mL",
"Status": "Active",
"LastUpdate": "2023-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120919",
"SamplePackage": "N",
"IndicationAndUsage": "Indications: 1 Cures most athlete's foot (tinea pedis)., 2 Cures most jock itch (tinea cruris) and ring worm (tinea corporis)., 3 Relieves itching, cracking, burning, and scaling which accompany these conditions., 4 Prevents most athlete's foot (tinea pedis) with daily use."
},
{
"NDCCode": "71205-511-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (71205-511-30) ",
"NDC11Code": "71205-0511-30",
"ProductNDC": "71205-511",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130513",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090867",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2023-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201203",
"SamplePackage": "N",
"IndicationAndUsage": "Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae., 3 Lymphogranuloma venereum caused by Chlamydia trachomatis., 4 Psittacosis (Ornithosis) due to Chlamydophila psittaci., 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis., 7 Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis., 8 Relapsing fever due to Borrelia recurrentis., 9 Chancroid caused by Haemophilus ducreyi., 10 Plague due to Yersinia pestis., 11 Tularemia due to Francisella tularensis., 12 Cholera caused by Vibrio cholerae., 13 Campylobacter fetus infections caused by Campylobacter fetus., 14 Brucellosis due to Brucella species (in conjunction with streptomycin)., 15 Bartonellosis due to Bartonella bacilliformis., 16 Granuloma inguinale caused by Klebsiella granulomatis.",
"Description": "Minocycline hydrochloride USP, is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is. C23H27N3O7HCl M.W. 493.94. Minocycline hydrochloride capsules USP for oral administration contain minocycline hydrochloride, USP equivalent to 50 mg, 75 mg, or 100 mg of minocycline and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, povidone, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, titanium dioxide, gelatin, D&C Yellow #10 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, black iron oxide, propylene glycol and shellac. In addition 50 mg capsules contains D&C Red #33 aluminum lake, FD&C Red #3 aluminum lake and FD&C Yellow #6 aluminum lake; 75 mg capsules contains FDA/E172 black iron oxide and 100 mg capsules contains D&C Red #28 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Red #40 aluminum lake and FDA/E172 red iron oxide."
},
{
"NDCCode": "71205-511-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (71205-511-60) ",
"NDC11Code": "71205-0511-60",
"ProductNDC": "71205-511",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130513",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090867",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2023-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201203",
"SamplePackage": "N",
"IndicationAndUsage": "Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae., 3 Lymphogranuloma venereum caused by Chlamydia trachomatis., 4 Psittacosis (Ornithosis) due to Chlamydophila psittaci., 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis., 7 Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis., 8 Relapsing fever due to Borrelia recurrentis., 9 Chancroid caused by Haemophilus ducreyi., 10 Plague due to Yersinia pestis., 11 Tularemia due to Francisella tularensis., 12 Cholera caused by Vibrio cholerae., 13 Campylobacter fetus infections caused by Campylobacter fetus., 14 Brucellosis due to Brucella species (in conjunction with streptomycin)., 15 Bartonellosis due to Bartonella bacilliformis., 16 Granuloma inguinale caused by Klebsiella granulomatis.",
"Description": "Minocycline hydrochloride USP, is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is. C23H27N3O7HCl M.W. 493.94. Minocycline hydrochloride capsules USP for oral administration contain minocycline hydrochloride, USP equivalent to 50 mg, 75 mg, or 100 mg of minocycline and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, povidone, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, titanium dioxide, gelatin, D&C Yellow #10 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, black iron oxide, propylene glycol and shellac. In addition 50 mg capsules contains D&C Red #33 aluminum lake, FD&C Red #3 aluminum lake and FD&C Yellow #6 aluminum lake; 75 mg capsules contains FDA/E172 black iron oxide and 100 mg capsules contains D&C Red #28 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Red #40 aluminum lake and FDA/E172 red iron oxide."
},
{
"NDCCode": "71205-511-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (71205-511-90) ",
"NDC11Code": "71205-0511-90",
"ProductNDC": "71205-511",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130513",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090867",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2023-05-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201203",
"SamplePackage": "N",
"IndicationAndUsage": "Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae., 3 Lymphogranuloma venereum caused by Chlamydia trachomatis., 4 Psittacosis (Ornithosis) due to Chlamydophila psittaci., 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis., 7 Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis., 8 Relapsing fever due to Borrelia recurrentis., 9 Chancroid caused by Haemophilus ducreyi., 10 Plague due to Yersinia pestis., 11 Tularemia due to Francisella tularensis., 12 Cholera caused by Vibrio cholerae., 13 Campylobacter fetus infections caused by Campylobacter fetus., 14 Brucellosis due to Brucella species (in conjunction with streptomycin)., 15 Bartonellosis due to Bartonella bacilliformis., 16 Granuloma inguinale caused by Klebsiella granulomatis.",
"Description": "Minocycline hydrochloride USP, is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is. C23H27N3O7HCl M.W. 493.94. Minocycline hydrochloride capsules USP for oral administration contain minocycline hydrochloride, USP equivalent to 50 mg, 75 mg, or 100 mg of minocycline and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, povidone, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, titanium dioxide, gelatin, D&C Yellow #10 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, black iron oxide, propylene glycol and shellac. In addition 50 mg capsules contains D&C Red #33 aluminum lake, FD&C Red #3 aluminum lake and FD&C Yellow #6 aluminum lake; 75 mg capsules contains FDA/E172 black iron oxide and 100 mg capsules contains D&C Red #28 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Red #40 aluminum lake and FDA/E172 red iron oxide."
},
{
"NDCCode": "72189-511-10",
"PackageDescription": "10 TABLET in 1 BOTTLE (72189-511-10) ",
"NDC11Code": "72189-0511-10",
"ProductNDC": "72189-511",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexamethasone",
"NonProprietaryName": "Dexamethasone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215604",
"LabelerName": "Direct_Rx",
"SubstanceName": "DEXAMETHASONE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230901",
"SamplePackage": "N",
"IndicationAndUsage": "Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic Diseases. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic Disorders. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Miscellaneous. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic Diseases. For the palliative management of leukemias and lymphomas. Nervous System. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Ophthalmic Diseases. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory Diseases. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low- dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.",
"Description": "Dexamethasone Tablets, USP for oral administration, are supplied in the following potencies, 1.5 mg, 2 mg, 4 mg and 6 mg. Inactive ingredients are Microcrystalline Cellulose, Lactose Anhydrous, Croscarmellose Sodium, Magnesium Stearate, FD&C Blue #1 Aluminum Lake (4 mg, 6 mg), D&C Red #27 Aluminum Lake (1.5 mg), FD&C Red #40 Aluminum Lake (1.5 mg), D&C Yellow #10 Aluminum Lake (1.5 mg, 4 mg, 6 mg). The molecular weight for dexamethasone is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The empirical formula is C22H29FO5 and the structural formula is. [structure]. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "73062-511-01",
"PackageDescription": "1000 mL in 1 BAG (73062-511-01) ",
"NDC11Code": "73062-0511-01",
"ProductNDC": "73062-511",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Puresan Antibacterial Foaming Hand Wash",
"NonProprietaryName": "Chloroxylenol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210820",
"EndMarketingDate": "20240720",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Avro Enterprises LLC",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": ".3",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210820",
"EndMarketingDatePackage": "20240720",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 Handwash to help reduce bacteria on the skin that potentially can cause disease., 2 Recommended for repeated use."
},
{
"NDCCode": "46994-047-62",
"PackageDescription": "24 BLISTER PACK in 1 CARTON (46994-047-62) > 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "46994-0047-62",
"ProductNDC": "46994-047",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Being Well Heartburn Relief",
"ProprietaryNameSuffix": "Acid Reducer",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078653",
"LabelerName": "Save-A-Lot Food Stores Ltd",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-11-29"
},
{
"NDCCode": "46994-069-27",
"PackageDescription": "368 g in 1 JAR (46994-069-27) ",
"NDC11Code": "46994-0069-27",
"ProductNDC": "46994-069",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Petroleum Skin Protectant",
"NonProprietaryName": "White Petrolatum",
"DosageFormName": "JELLY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141108",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Moran Foods Inc",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141108",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily protects minor: cuts scrapes burns. temporarily protects and helps relieve chapped or cracked skin and lips. helps protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "46994-072-86",
"PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (46994-072-86) ",
"NDC11Code": "46994-0072-86",
"ProductNDC": "46994-072",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Being Well Antiseptic",
"NonProprietaryName": "Eucalyptol, Menthol, Methyl Salicylate, Thymol",
"DosageFormName": "MOUTHWASH",
"RouteName": "ORAL",
"StartMarketingDate": "20141003",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "Save-A-Lot Food Stores, LTD",
"SubstanceName": "EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL",
"StrengthNumber": ".92; .42; .6; .64",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20141003",
"SamplePackage": "N"
},
{
"NDCCode": "46994-150-34",
"PackageDescription": "237 mL in 1 BOTTLE (46994-150-34) ",
"NDC11Code": "46994-0150-34",
"ProductNDC": "46994-150",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Being Well Night Time Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20150914",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Save-A-Lot Food Stores Ltd",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "650; 30; 12.5",
"StrengthUnit": "mg/30mL; mg/30mL; mg/30mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20150914",
"SamplePackage": "N"
},
{
"NDCCode": "46994-157-33",
"PackageDescription": "175 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (46994-157-33) ",
"NDC11Code": "46994-0157-33",
"ProductNDC": "46994-157",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19960210",
"EndMarketingDate": "20251004",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "SAVE-A-LOT FOOD STORES, LTD.",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19960210",
"EndMarketingDatePackage": "20251004",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves: 1 pain and fever of colds, 2 toothache, 3 menstrual pain, 4 muscle pain, 5 headache, 6 minor pain of arthritis."
},
{
"NDCCode": "46994-235-15",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (46994-235-15) > 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "46994-0235-15",
"ProductNDC": "46994-235",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Strength Non-aspirin Pm",
"NonProprietaryName": "Acetaminophen And Diphenhydramine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19940515",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "SAVE-A-LOT FOOD STORES, LTD.",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "500; 25",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2016-02-19"
},
{
"NDCCode": "46994-291-12",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (46994-291-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
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"ProductNDC": "46994-291",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19880524",
"EndMarketingDate": "20250614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075010",
"LabelerName": "SAVE-A-LOT FOOD STORES, LTD.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19880524",
"EndMarketingDatePackage": "20250614",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:backachemuscular achestoothachemenstrual crampsheadachethe common coldminor pain of arthritis. temporarily reduces fever ."
}
]
}
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<NDCCode>46994-511-23</NDCCode>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Being Well Body</ProprietaryName>
<ProprietaryNameSuffix>Dry Scalp Care</ProprietaryNameSuffix>
<NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
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<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part358H</ApplicationNumber>
<LabelerName>Save-A-Lot Food Stores Ltd</LabelerName>
<SubstanceName>PYRITHIONE ZINC</SubstanceName>
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<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses helps eliminate irritation and flaking associated with dandruff.</IndicationAndUsage>
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<PackageDescription>700 mL in 1 BOTTLE, PLASTIC (46994-510-23)</PackageDescription>
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<ProductNDC>46994-510</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Being Well Body</ProprietaryName>
<ProprietaryNameSuffix>2in1 Dandruff And Conditioner</ProprietaryNameSuffix>
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<StartMarketingDate>20130325</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part358H</ApplicationNumber>
<LabelerName>Save-A-Lot Food Stores Ltd</LabelerName>
<SubstanceName>PYRITHIONE ZINC</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses helps eliminate irritation and flaking associated with dandruff.</IndicationAndUsage>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
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<LabelerName>Save-A-Lot Food Stores Ltd</LabelerName>
<SubstanceName>PYRITHIONE ZINC</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses helps eliminate irritation and flaking associated with dandruff.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50157-511-23</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE, PLASTIC (50157-511-23) </PackageDescription>
<NDC11Code>50157-0511-23</NDC11Code>
<ProductNDC>50157-511</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Moonlite Antibacterial</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200923</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Brands International Corporation</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses Effective in destorying(harmful) bacteria to provide antiseptic cleansing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>46994-175-12</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (46994-175-12) > 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>46994-0175-12</NDC11Code>
<ProductNDC>46994-175</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930402</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>SAVE-A-LOT FOOD STORES, LTD.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>46994-568-50</NDCCode>
<PackageDescription>710 mL in 1 BOTTLE, DISPENSING (46994-568-50) </PackageDescription>
<NDC11Code>46994-0568-50</NDC11Code>
<ProductNDC>46994-568</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ultra Dish</ProprietaryName>
<NonProprietaryName>Chloroxylenol 0.30%</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160711</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Save A Lot</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>3.06</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160711</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for handwashing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0054-4496-13</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0054-4496-13) </PackageDescription>
<NDC11Code>00054-4496-13</NDC11Code>
<ProductNDC>0054-4496</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Leucovorin Calcium</ProprietaryName>
<NonProprietaryName>Leucovorin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072733</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>LEUCOVORIN CALCIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930322</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5 Limitations of Use, 6 Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).</IndicationAndUsage>
<Description>Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>0054-4496-25</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0054-4496-25) </PackageDescription>
<NDC11Code>00054-4496-25</NDC11Code>
<ProductNDC>0054-4496</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Leucovorin Calcium</ProprietaryName>
<NonProprietaryName>Leucovorin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072733</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>LEUCOVORIN CALCIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930322</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5 Limitations of Use, 6 Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).</IndicationAndUsage>
<Description>Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>0054-4497-05</NDCCode>
<PackageDescription>12 TABLET in 1 BOTTLE (0054-4497-05) </PackageDescription>
<NDC11Code>00054-4497-05</NDC11Code>
<ProductNDC>0054-4497</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Leucovorin Calcium</ProprietaryName>
<NonProprietaryName>Leucovorin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072734</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>LEUCOVORIN CALCIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930322</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5 Limitations of Use, 6 Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).</IndicationAndUsage>
<Description>Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>0054-4497-10</NDCCode>
<PackageDescription>24 TABLET in 1 BOTTLE (0054-4497-10) </PackageDescription>
<NDC11Code>00054-4497-10</NDC11Code>
<ProductNDC>0054-4497</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Leucovorin Calcium</ProprietaryName>
<NonProprietaryName>Leucovorin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072734</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>LEUCOVORIN CALCIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930322</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5 Limitations of Use, 6 Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).</IndicationAndUsage>
<Description>Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>0054-4498-10</NDCCode>
<PackageDescription>24 TABLET in 1 BOTTLE (0054-4498-10) </PackageDescription>
<NDC11Code>00054-4498-10</NDC11Code>
<ProductNDC>0054-4498</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Leucovorin Calcium</ProprietaryName>
<NonProprietaryName>Leucovorin Calcium</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>19930222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072735</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>LEUCOVORIN CALCIUM</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
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<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930322</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5 Limitations of Use, 6 Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).</IndicationAndUsage>
<Description>Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch.</Description>
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<NDC>
<NDCCode>0054-4499-11</NDCCode>
<PackageDescription>25 TABLET in 1 BOTTLE (0054-4499-11) </PackageDescription>
<NDC11Code>00054-4499-11</NDC11Code>
<ProductNDC>0054-4499</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Leucovorin Calcium</ProprietaryName>
<NonProprietaryName>Leucovorin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072736</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>LEUCOVORIN CALCIUM</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930322</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5 Limitations of Use, 6 Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).</IndicationAndUsage>
<Description>Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>0054-8496-19</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 CARTON (0054-8496-19) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00054-8496-19</NDC11Code>
<ProductNDC>0054-8496</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Leucovorin Calcium</ProprietaryName>
<NonProprietaryName>Leucovorin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19930222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072733</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>LEUCOVORIN CALCIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930322</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Leucovorin is a folate analog indicated: 1 To reduce the toxicity of:, 2 oMethotrexate in adult patients with impaired methotrexate elimination, and, 3 oFolic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult patients. (1.1) , 4 For the treatment of cerebral folate transport deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). (1.2), 5 Limitations of Use, 6 Leucovorin is not recommended for use in patients with a deficiency of methenyltetrahydrofolate synthetase (MTHFS) because MTHFS is a primary enzyme in the metabolism of leucovorin to 5-methenyltetrahydrofolate. (1.2).</IndicationAndUsage>
<Description>Leucovorin is a racemic mixture of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-Levoisomer, known as Citrovorum factor, or (-)-folinic acid or levoleucovorin. Leucovorin is a water soluble form of reduced folate in the folate group. The chemical name of leucovorin, a folate analog, is the calcium salt of N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl]-L-glutamic acid. The molecular formula is C20H21CaN7O7 and the molecular weight is 511.51 g/mol. The structural formula of leucovorin calcium is. C20H21CaN7O7 M.W. 511.51. Leucovorin calcium tablets, USP are for oral administration. Each 5 mg, 10 mg, 15 mg or 25 mg leucovorin tablets are either equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, USP, respectively. In addition, each tablet contains the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (15 mg and 25 mg), magnesium stearate, microcrystalline cellulose, povidone and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>43547-511-09</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (43547-511-09) </PackageDescription>
<NDC11Code>43547-0511-09</NDC11Code>
<ProductNDC>43547-511</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207883</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for: : 1 Management of neuropathic pain associated with diabetic peripheral neuropathy , 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia , 5 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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 corn starch, lactose monohydrate, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the caramel capsule shells (25 mg, 50 mg, 75 mg, 150 mg, and 300 mg) contain red iron oxide and the light salmon capsule shells (225 mg) contain red iron oxide and yellow iron oxide. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>43547-511-50</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (43547-511-50) </PackageDescription>
<NDC11Code>43547-0511-50</NDC11Code>
<ProductNDC>43547-511</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207883</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for: : 1 Management of neuropathic pain associated with diabetic peripheral neuropathy , 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older, 4 Management of fibromyalgia , 5 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 C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. 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 corn starch, lactose monohydrate, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the caramel capsule shells (25 mg, 50 mg, 75 mg, 150 mg, and 300 mg) contain red iron oxide and the light salmon capsule shells (225 mg) contain red iron oxide and yellow iron oxide. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>50941-511-00</NDCCode>
<PackageDescription>355 mL in 1 BOTTLE (50941-511-00) </PackageDescription>
<NDC11Code>50941-0511-00</NDC11Code>
<ProductNDC>50941-511</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20230612</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>L Perrigo Company</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 200; 5</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL; mg/15mL; mg/15mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-06-13</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>12-JUN-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>57218-511-01</NDCCode>
<PackageDescription>25 kg in 1 DRUM (57218-511-01) </PackageDescription>
<NDC11Code>57218-0511-01</NDC11Code>
<ProductNDC>57218-511</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ephedrine Sulfate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20050101</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Malladi Drugs & Pharmaceuticals Limited</LabelerName>
<SubstanceName>EPHEDRINE SULFATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-23</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-JAN-05</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>63347-511-03</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE (63347-511-03) </PackageDescription>
<NDC11Code>63347-0511-03</NDC11Code>
<ProductNDC>63347-511</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tineacide</ProprietaryName>
<NonProprietaryName>Tolnaftate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120919</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M005</ApplicationNumber>
<LabelerName>Blaine Labs Inc.</LabelerName>
<SubstanceName>TOLNAFTATE</SubstanceName>
<StrengthNumber>140</StrengthNumber>
<StrengthUnit>mg/15mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications: 1 Cures most athlete's foot (tinea pedis)., 2 Cures most jock itch (tinea cruris) and ring worm (tinea corporis)., 3 Relieves itching, cracking, burning, and scaling which accompany these conditions., 4 Prevents most athlete's foot (tinea pedis) with daily use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71205-511-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (71205-511-30) </PackageDescription>
<NDC11Code>71205-0511-30</NDC11Code>
<ProductNDC>71205-511</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130513</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090867</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae., 3 Lymphogranuloma venereum caused by Chlamydia trachomatis., 4 Psittacosis (Ornithosis) due to Chlamydophila psittaci., 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis., 7 Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis., 8 Relapsing fever due to Borrelia recurrentis., 9 Chancroid caused by Haemophilus ducreyi., 10 Plague due to Yersinia pestis., 11 Tularemia due to Francisella tularensis., 12 Cholera caused by Vibrio cholerae., 13 Campylobacter fetus infections caused by Campylobacter fetus., 14 Brucellosis due to Brucella species (in conjunction with streptomycin)., 15 Bartonellosis due to Bartonella bacilliformis., 16 Granuloma inguinale caused by Klebsiella granulomatis.</IndicationAndUsage>
<Description>Minocycline hydrochloride USP, is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is. C23H27N3O7HCl M.W. 493.94. Minocycline hydrochloride capsules USP for oral administration contain minocycline hydrochloride, USP equivalent to 50 mg, 75 mg, or 100 mg of minocycline and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, povidone, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, titanium dioxide, gelatin, D&C Yellow #10 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, black iron oxide, propylene glycol and shellac. In addition 50 mg capsules contains D&C Red #33 aluminum lake, FD&C Red #3 aluminum lake and FD&C Yellow #6 aluminum lake; 75 mg capsules contains FDA/E172 black iron oxide and 100 mg capsules contains D&C Red #28 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Red #40 aluminum lake and FDA/E172 red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>71205-511-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (71205-511-60) </PackageDescription>
<NDC11Code>71205-0511-60</NDC11Code>
<ProductNDC>71205-511</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130513</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090867</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae., 3 Lymphogranuloma venereum caused by Chlamydia trachomatis., 4 Psittacosis (Ornithosis) due to Chlamydophila psittaci., 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis., 7 Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis., 8 Relapsing fever due to Borrelia recurrentis., 9 Chancroid caused by Haemophilus ducreyi., 10 Plague due to Yersinia pestis., 11 Tularemia due to Francisella tularensis., 12 Cholera caused by Vibrio cholerae., 13 Campylobacter fetus infections caused by Campylobacter fetus., 14 Brucellosis due to Brucella species (in conjunction with streptomycin)., 15 Bartonellosis due to Bartonella bacilliformis., 16 Granuloma inguinale caused by Klebsiella granulomatis.</IndicationAndUsage>
<Description>Minocycline hydrochloride USP, is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is. C23H27N3O7HCl M.W. 493.94. Minocycline hydrochloride capsules USP for oral administration contain minocycline hydrochloride, USP equivalent to 50 mg, 75 mg, or 100 mg of minocycline and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, povidone, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, titanium dioxide, gelatin, D&C Yellow #10 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, black iron oxide, propylene glycol and shellac. In addition 50 mg capsules contains D&C Red #33 aluminum lake, FD&C Red #3 aluminum lake and FD&C Yellow #6 aluminum lake; 75 mg capsules contains FDA/E172 black iron oxide and 100 mg capsules contains D&C Red #28 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Red #40 aluminum lake and FDA/E172 red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>71205-511-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (71205-511-90) </PackageDescription>
<NDC11Code>71205-0511-90</NDC11Code>
<ProductNDC>71205-511</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130513</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090867</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae., 2 Respiratory tract infections caused by Mycoplasma pneumoniae., 3 Lymphogranuloma venereum caused by Chlamydia trachomatis., 4 Psittacosis (Ornithosis) due to Chlamydophila psittaci., 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence., 6 Inclusion conjunctivitis caused by Chlamydia trachomatis., 7 Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis., 8 Relapsing fever due to Borrelia recurrentis., 9 Chancroid caused by Haemophilus ducreyi., 10 Plague due to Yersinia pestis., 11 Tularemia due to Francisella tularensis., 12 Cholera caused by Vibrio cholerae., 13 Campylobacter fetus infections caused by Campylobacter fetus., 14 Brucellosis due to Brucella species (in conjunction with streptomycin)., 15 Bartonellosis due to Bartonella bacilliformis., 16 Granuloma inguinale caused by Klebsiella granulomatis.</IndicationAndUsage>
<Description>Minocycline hydrochloride USP, is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is. C23H27N3O7HCl M.W. 493.94. Minocycline hydrochloride capsules USP for oral administration contain minocycline hydrochloride, USP equivalent to 50 mg, 75 mg, or 100 mg of minocycline and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, povidone, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, titanium dioxide, gelatin, D&C Yellow #10 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, black iron oxide, propylene glycol and shellac. In addition 50 mg capsules contains D&C Red #33 aluminum lake, FD&C Red #3 aluminum lake and FD&C Yellow #6 aluminum lake; 75 mg capsules contains FDA/E172 black iron oxide and 100 mg capsules contains D&C Red #28 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Red #40 aluminum lake and FDA/E172 red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>72189-511-10</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (72189-511-10) </PackageDescription>
<NDC11Code>72189-0511-10</NDC11Code>
<ProductNDC>72189-511</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexamethasone</ProprietaryName>
<NonProprietaryName>Dexamethasone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215604</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>DEXAMETHASONE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic Diseases. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic Disorders. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Miscellaneous. Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic Diseases. For the palliative management of leukemias and lymphomas. Nervous System. Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Ophthalmic Diseases. Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases. To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory Diseases. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low- dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>Dexamethasone Tablets, USP for oral administration, are supplied in the following potencies, 1.5 mg, 2 mg, 4 mg and 6 mg. Inactive ingredients are Microcrystalline Cellulose, Lactose Anhydrous, Croscarmellose Sodium, Magnesium Stearate, FD&C Blue #1 Aluminum Lake (4 mg, 6 mg), D&C Red #27 Aluminum Lake (1.5 mg), FD&C Red #40 Aluminum Lake (1.5 mg), D&C Yellow #10 Aluminum Lake (1.5 mg, 4 mg, 6 mg). The molecular weight for dexamethasone is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The empirical formula is C22H29FO5 and the structural formula is. [structure]. Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>73062-511-01</NDCCode>
<PackageDescription>1000 mL in 1 BAG (73062-511-01) </PackageDescription>
<NDC11Code>73062-0511-01</NDC11Code>
<ProductNDC>73062-511</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Puresan Antibacterial Foaming Hand Wash</ProprietaryName>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210820</StartMarketingDate>
<EndMarketingDate>20240720</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Avro Enterprises LLC</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210820</StartMarketingDatePackage>
<EndMarketingDatePackage>20240720</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 Handwash to help reduce bacteria on the skin that potentially can cause disease., 2 Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>46994-047-62</NDCCode>
<PackageDescription>24 BLISTER PACK in 1 CARTON (46994-047-62) > 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>46994-0047-62</NDC11Code>
<ProductNDC>46994-047</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Being Well Heartburn Relief</ProprietaryName>
<ProprietaryNameSuffix>Acid Reducer</ProprietaryNameSuffix>
<NonProprietaryName>Ranitidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078653</ApplicationNumber>
<LabelerName>Save-A-Lot Food Stores Ltd</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>46994-069-27</NDCCode>
<PackageDescription>368 g in 1 JAR (46994-069-27) </PackageDescription>
<NDC11Code>46994-0069-27</NDC11Code>
<ProductNDC>46994-069</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Petroleum Skin Protectant</ProprietaryName>
<NonProprietaryName>White Petrolatum</NonProprietaryName>
<DosageFormName>JELLY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141108</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Moran Foods Inc</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily protects minor: cuts scrapes burns. temporarily protects and helps relieve chapped or cracked skin and lips. helps protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>46994-072-86</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE, PLASTIC (46994-072-86) </PackageDescription>
<NDC11Code>46994-0072-86</NDC11Code>
<ProductNDC>46994-072</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Being Well Antiseptic</ProprietaryName>
<NonProprietaryName>Eucalyptol, Menthol, Methyl Salicylate, Thymol</NonProprietaryName>
<DosageFormName>MOUTHWASH</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141003</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part356</ApplicationNumber>
<LabelerName>Save-A-Lot Food Stores, LTD</LabelerName>
<SubstanceName>EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL</SubstanceName>
<StrengthNumber>.92; .42; .6; .64</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>46994-150-34</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE (46994-150-34) </PackageDescription>
<NDC11Code>46994-0150-34</NDC11Code>
<ProductNDC>46994-150</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Being Well Night Time Cold And Flu</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150914</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Save-A-Lot Food Stores Ltd</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>650; 30; 12.5</StrengthNumber>
<StrengthUnit>mg/30mL; mg/30mL; mg/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150914</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>46994-157-33</NDCCode>
<PackageDescription>175 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (46994-157-33) </PackageDescription>
<NDC11Code>46994-0157-33</NDC11Code>
<ProductNDC>46994-157</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspirin</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960210</StartMarketingDate>
<EndMarketingDate>20251004</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>SAVE-A-LOT FOOD STORES, LTD.</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19960210</StartMarketingDatePackage>
<EndMarketingDatePackage>20251004</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves: 1 pain and fever of colds, 2 toothache, 3 menstrual pain, 4 muscle pain, 5 headache, 6 minor pain of arthritis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>46994-235-15</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (46994-235-15) > 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>46994-0235-15</NDC11Code>
<ProductNDC>46994-235</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Extra Strength Non-aspirin Pm</ProprietaryName>
<NonProprietaryName>Acetaminophen And Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19940515</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>SAVE-A-LOT FOOD STORES, LTD.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-02-19</LastUpdate>
</NDC>
<NDC>
<NDCCode>46994-291-12</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (46994-291-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>46994-0291-12</NDC11Code>
<ProductNDC>46994-291</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19880524</StartMarketingDate>
<EndMarketingDate>20250614</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075010</ApplicationNumber>
<LabelerName>SAVE-A-LOT FOOD STORES, LTD.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19880524</StartMarketingDatePackage>
<EndMarketingDatePackage>20250614</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to:backachemuscular achestoothachemenstrual crampsheadachethe common coldminor pain of arthritis. temporarily reduces fever .</IndicationAndUsage>
</NDC>
</NDCList>