{
"NDC": [
{
"NDCCode": "58468-7820-3",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (58468-7820-3) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "58468-7820-03",
"ProductNDC": "58468-7820",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Caprelsa",
"NonProprietaryName": "Vandetanib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110725",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022405",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "VANDETANIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110725",
"SamplePackage": "N",
"IndicationAndUsage": "CAPRELSA is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA.",
"Description": "Vandetanib has the chemical name N-(4-bromo-2-fluorophenyl)-6-methoxy-7-[(1-methylpiperidin-4-yl) methoxy]quinazolin-4-amine. The structural and molecular formulas are. C22H24BrFN4O2. Vandetanib has a molecular weight of 475.36 g/mol. Vandetanib exhibits pH-dependent solubility, with increased solubility at lower pH. Vandetanib is practically insoluble in water with a value of 0.008 mg/mL at 25°C (77°F). CAPRELSA tablets for daily oral administration are available in two dosage strengths containing either 100 mg or 300 mg of vandetanib. The tablet cores contain the following inactive ingredients: calcium hydrogen phosphate dihydrate, crospovidone, magnesium stearate, microcrystalline cellulose, and povidone. The tablet film-coat contains the following inactive ingredients: hypromellose 2910, macrogol 300, and titanium dioxide E171."
},
{
"NDCCode": "63629-7820-3",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7820-3) ",
"NDC11Code": "63629-7820-03",
"ProductNDC": "63629-7820",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"ProprietaryNameSuffix": "Xl",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20171001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207224",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220209",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (XL) is an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient. (1).",
"Description": "Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets (XL) are supplied for oral administration as 150 mg and 300 mg white, round, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: colloidal silicon dioxide, copovidone, ethyl cellulose, hydroxypropyl cellulose, glyceryl behenate, methacrylic acid copolymer and silicon dioxide. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP dissolution test is pending."
},
{
"NDCCode": "68788-7820-3",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-7820-3) ",
"NDC11Code": "68788-7820-03",
"ProductNDC": "68788-7820",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077284",
"LabelerName": "Preferred Pharmaceuticals Inc.",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20201113",
"SamplePackage": "N"
},
{
"NDCCode": "58468-0021-3",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (58468-0021-3)",
"NDC11Code": "58468-0021-03",
"ProductNDC": "58468-0021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Renagel",
"NonProprietaryName": "Renagel",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080606",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021179",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "SEVELAMER HYDROCHLORIDE",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-12-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "58468-0121-3",
"PackageDescription": "7 CAPSULE, LIQUID FILLED in 1 BOTTLE (58468-0121-3) ",
"NDC11Code": "58468-0121-03",
"ProductNDC": "58468-0121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hectorol",
"NonProprietaryName": "Doxercalciferol",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20090803",
"EndMarketingDate": "20190131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020862",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "DOXERCALCIFEROL",
"StrengthNumber": "2.5",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Ergocalciferols [CS],Vitamin D2 Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090803",
"EndMarketingDatePackage": "20190131",
"SamplePackage": "N"
},
{
"NDCCode": "58468-0124-3",
"PackageDescription": "7 CAPSULE, LIQUID FILLED in 1 BOTTLE (58468-0124-3) ",
"NDC11Code": "58468-0124-03",
"ProductNDC": "58468-0124",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hectorol",
"NonProprietaryName": "Doxercalciferol",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20090803",
"EndMarketingDate": "20190131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020862",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "DOXERCALCIFEROL",
"StrengthNumber": "1",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Ergocalciferols [CS],Vitamin D2 Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090803",
"EndMarketingDatePackage": "20190131",
"SamplePackage": "N"
},
{
"NDCCode": "58468-0131-4",
"PackageDescription": "90 PACKET in 1 CARTON (58468-0131-4) > 1 POWDER, FOR SUSPENSION in 1 PACKET (58468-0131-3) ",
"NDC11Code": "58468-0131-04",
"ProductNDC": "58468-0131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Renvela",
"NonProprietaryName": "Sevelamer Carbonate",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20090812",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022318",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "SEVELAMER CARBONATE",
"StrengthNumber": "2400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20090812",
"SamplePackage": "N"
},
{
"NDCCode": "58468-0131-5",
"PackageDescription": "15 PACKET in 1 CARTON (58468-0131-5) > 1 POWDER, FOR SUSPENSION in 1 PACKET (58468-0131-3) ",
"NDC11Code": "58468-0131-05",
"ProductNDC": "58468-0131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Renvela",
"NonProprietaryName": "Sevelamer Carbonate",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20090812",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022318",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "SEVELAMER CARBONATE",
"StrengthNumber": "2400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20090812",
"SamplePackage": "N"
},
{
"NDCCode": "58468-0210-3",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (58468-0210-3) / 5 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "58468-0210-03",
"ProductNDC": "58468-0210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aubagio",
"NonProprietaryName": "Teriflunomide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202992",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "TERIFLUNOMIDE",
"StrengthNumber": "14",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130501",
"SamplePackage": "Y",
"IndicationAndUsage": "AUBAGIO® is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "AUBAGIO (teriflunomide) is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white to almost white powder that is sparingly soluble in acetone, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. AUBAGIO tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: lactose monohydrate, corn starch, hydroxypropyl cellulose, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate. The film coating for the 14 mg tablet is made of hypromellose, titanium dioxide, talc, polyethylene glycol and indigo carmine aluminum lake. In addition to these, the 7 mg tablet film coating includes iron oxide yellow."
},
{
"NDCCode": "58468-0211-3",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (58468-0211-3) / 5 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "58468-0211-03",
"ProductNDC": "58468-0211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aubagio",
"NonProprietaryName": "Teriflunomide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202992",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "TERIFLUNOMIDE",
"StrengthNumber": "7",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130501",
"SamplePackage": "Y",
"IndicationAndUsage": "AUBAGIO® is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "AUBAGIO (teriflunomide) is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white to almost white powder that is sparingly soluble in acetone, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. AUBAGIO tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: lactose monohydrate, corn starch, hydroxypropyl cellulose, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate. The film coating for the 14 mg tablet is made of hypromellose, titanium dioxide, talc, polyethylene glycol and indigo carmine aluminum lake. In addition to these, the 7 mg tablet film coating includes iron oxide yellow."
},
{
"NDCCode": "58468-0357-3",
"PackageDescription": "3 VIAL, SINGLE-USE in 1 CARTON (58468-0357-3) / 1 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "58468-0357-03",
"ProductNDC": "58468-0357",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Campath",
"NonProprietaryName": "Alemtuzumab",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20091130",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103948",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "ALEMTUZUMAB",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "CD52-directed Antibody Interactions [MoA], CD52-directed Cytolytic Antibody [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20091130",
"SamplePackage": "N",
"IndicationAndUsage": "CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).",
"Description": "Alemtuzumab, a CD52-directed cytolytic antibody, is a recombinant DNA-derived humanized monoclonal antibody (CAMPATH-1H). CAMPATH-1H is an IgG1 kappa antibody with human variable framework and constant regions, and complementarity-determining regions from a murine (rat) monoclonal antibody (CAMPATH-1G). The CAMPATH-1H antibody has an approximate molecular weight of 150 kD. CAMPATH is produced in mammalian cell (Chinese hamster ovary) suspension culture in a medium containing neomycin. Neomycin is not detectable in the final product. CAMPATH (alemtuzumab) injection is a sterile, clear, colorless, isotonic solution (pH 6.8–7.4) in a single-dose vial for intravenous use. Each single-dose vial of CAMPATH contains 30 mg alemtuzumab, 8.0 mg sodium chloride, 1.44 mg dibasic sodium phosphate, 0.2 mg potassium chloride, 0.2 mg monobasic potassium phosphate, 0.1 mg polysorbate 80, and 0.0187 mg disodium edetate dihydrate. No preservatives are added."
},
{
"NDCCode": "58468-7840-3",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (58468-7840-3) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "58468-7840-03",
"ProductNDC": "58468-7840",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Caprelsa",
"NonProprietaryName": "Vandetanib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110725",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022405",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "VANDETANIB",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110725",
"SamplePackage": "N",
"IndicationAndUsage": "CAPRELSA is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA.",
"Description": "Vandetanib has the chemical name N-(4-bromo-2-fluorophenyl)-6-methoxy-7-[(1-methylpiperidin-4-yl) methoxy]quinazolin-4-amine. The structural and molecular formulas are. C22H24BrFN4O2. Vandetanib has a molecular weight of 475.36 g/mol. Vandetanib exhibits pH-dependent solubility, with increased solubility at lower pH. Vandetanib is practically insoluble in water with a value of 0.008 mg/mL at 25°C (77°F). CAPRELSA tablets for daily oral administration are available in two dosage strengths containing either 100 mg or 300 mg of vandetanib. The tablet cores contain the following inactive ingredients: calcium hydrogen phosphate dihydrate, crospovidone, magnesium stearate, microcrystalline cellulose, and povidone. The tablet film-coat contains the following inactive ingredients: hypromellose 2910, macrogol 300, and titanium dioxide E171."
},
{
"NDCCode": "58468-7860-3",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (58468-7860-3) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "58468-7860-03",
"ProductNDC": "58468-7860",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Caprelsa",
"NonProprietaryName": "Vandetanib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220624",
"MarketingCategoryName": "UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "VANDETANIB",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protein Kinase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220624",
"SamplePackage": "N"
},
{
"NDCCode": "0169-7820-01",
"PackageDescription": "1 KIT in 1 KIT (0169-7820-01) * 4 mL in 1 VIAL, GLASS (0169-7821-11) * 4 mL in 1 SYRINGE, GLASS (0169-7008-98) ",
"NDC11Code": "00169-7820-01",
"ProductNDC": "0169-7820",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Novoeight",
"NonProprietaryName": "Antihemophilic Factor Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20150401",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125466",
"LabelerName": "Novo Nordisk",
"Status": "Active",
"LastUpdate": "2024-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150401",
"SamplePackage": "N",
"IndicationAndUsage": "Novoeight, Antihemophilic Factor (Recombinant), is a human antihemophilic factor (human blood coagulation. factor VIII (FVIII)) indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes , 2 Perioperative management , 3 Routine prophylaxis to reduce the frequency of bleeding episodes .",
"Description": "Novoeight is formulated as a sterile, non-pyrogenic, lyophilized powder for intravenous injection after reconstitution with the diluent (0.9% sodium chloride). Novoeight is available in single-dose vials that contain nominally 250, 500, 1000, 1500, 2000 or 3000 international units (IU) per vial. When reconstituted with the appropriate volume of diluent, the product contains the following components per mL: 18 mg sodium chloride, 1.5 mg L-histidine, 3 mg sucrose, 0.1 mg polysorbate 80, 0.055 mg L-methionine and 0.25 mg calcium chloride dihydrate. The product contains no preservative. Each vial of Novoeight is labeled with the actual rFVIII activity expressed in IU determined by the one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for FVIII Concentrates. One IU, as defined by the WHO standard for human FVIII, is approximately equal to the level of FVIII activity in 1 mL of fresh pooled human plasma. The specific activity of Novoeight is approximately 8340 IU per milligram of protein. The active ingredient in Novoeight is a recombinant (r) analogue of human coagulation factor VIII (FVIII) with a molecular mass of 166 kDa, calculated excluding post-translational modifications. The rFVIII molecule in Novoeight is a glycoprotein containing a heavy chain and a light chain, with 21 of the 908 amino acids of the B-domain of endogenous FVIII connected to the C-terminus of the heavy chain. Once activated, the resulting rFVIIIa has a comparable structure to the endogenous FVIIIa. Novoeight is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line which secretes rFVIII into the cell culture medium. The rFVIII protein is purified using a series of chromatography steps, one of which is the use of an immunoaffinity column in which a monoclonal antibody, produced in CHO cells and directed against FVIII, is employed to selectively isolate the rFVIII from the medium. The production process includes two dedicated viral clearance steps - a detergent treatment step for inactivation and a 20-nm filtration step for removal of viruses. No additives of human or animal origin are used in the cell culture, purification and formulation of Novoeight."
},
{
"NDCCode": "0480-7820-56",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0480-7820-56) ",
"NDC11Code": "00480-7820-56",
"ProductNDC": "0480-7820",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fingolimod",
"NonProprietaryName": "Fingolimod",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208008",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "FINGOLIMOD HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240214",
"SamplePackage": "N",
"IndicationAndUsage": "Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.",
"Description": "Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below. Fingolimod hydrochloride, USP is a white to off-white solid that is freely soluble in water and alcohol and soluble in propylene glycol. It has a molecular weight of 343.93 g/mol. Fingolimod is provided as 0.5 mg hard gelatin capsules for oral use. Each 0.5 mg capsule contains 0.56 mg of fingolimod hydrochloride USP, equivalent to 0.5 mg of fingolimod. Each capsule contains the following inactive ingredients: pregelatinized starch (corn) and sodium lauryl sulfate. The capsule shell contains gelatin, iron oxide yellow, and titanium dioxide. In addition, the imprinting ink contains the following: black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution."
},
{
"NDCCode": "50090-7820-0",
"PackageDescription": "120 TABLET in 1 BOTTLE (50090-7820-0) ",
"NDC11Code": "50090-7820-00",
"ProductNDC": "50090-7820",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091491",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251211",
"SamplePackage": "N",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (green), 750 mg (pink), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide and additional agents listed below. 250 mg tablets: FD&C Blue #2/indigo carmine aluminum lake. 500 mg tablets: D&C Yellow #10/aluminum lake and FD&C Blue #1/brilliant blue FCF aluminum lake. 750 mg tablets: FD&C Red #40/alura red AC aluminum lake, FD&C Yellow #6/sunset yellow FCF aluminum lake, and FD&C Blue #1/brilliant blue FCF aluminum lake. Meets USP Dissolution Test 3."
},
{
"NDCCode": "50090-7820-1",
"PackageDescription": "500 TABLET in 1 BOTTLE (50090-7820-1) ",
"NDC11Code": "50090-7820-01",
"ProductNDC": "50090-7820",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091491",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251211",
"SamplePackage": "N",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (green), 750 mg (pink), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide and additional agents listed below. 250 mg tablets: FD&C Blue #2/indigo carmine aluminum lake. 500 mg tablets: D&C Yellow #10/aluminum lake and FD&C Blue #1/brilliant blue FCF aluminum lake. 750 mg tablets: FD&C Red #40/alura red AC aluminum lake, FD&C Yellow #6/sunset yellow FCF aluminum lake, and FD&C Blue #1/brilliant blue FCF aluminum lake. Meets USP Dissolution Test 3."
},
{
"NDCCode": "58468-0021-1",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58468-0021-1) ",
"NDC11Code": "58468-0021-01",
"ProductNDC": "58468-0021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Renagel",
"NonProprietaryName": "Sevelamer Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080606",
"EndMarketingDate": "20240131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021179",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "SEVELAMER HYDROCHLORIDE",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20080606",
"EndMarketingDatePackage": "20240131",
"SamplePackage": "N",
"IndicationAndUsage": "Renagel ®is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of Renagel in CKD patients who are not on dialysis have not been studied.",
"Description": "The active ingredient in Renagel tablets is sevelamer hydrochloride, a polymeric amine that binds phosphate and is meant for oral administration. Sevelamer hydrochloride is poly(allylamine hydrochloride) crosslinked with epichlorohydrin in which 40% of the amines are protonated. It is known chemically as poly(allylamine- co-N,N'-diallyl-1,3-diamino-2-hydroxypropane) hydrochloride. Sevelamer hydrochloride is hydrophilic, but insoluble in water. The structure is represented in Figure 1. Figure 1: Chemical Structure of Sevelamer Hydrochloride. The primary amine groups shown in the structure are derived directly from poly(allylamine hydrochloride). The crosslinking groups consist of two secondary amine groups derived from poly(allylamine hydrochloride) and one molecule of epichlorohydrin."
},
{
"NDCCode": "58468-0030-2",
"PackageDescription": "2 VIAL, SINGLE-DOSE in 1 CARTON (58468-0030-2) / 1 mL in 1 VIAL, SINGLE-DOSE (58468-0030-1) ",
"NDC11Code": "58468-0030-02",
"ProductNDC": "58468-0030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Thyrogen",
"NonProprietaryName": "Thyrotropin Alfa",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "19981130",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA020898",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "THYROTROPIN ALFA",
"StrengthNumber": ".9",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Thyroid Stimulating Hormone [EPC], Thyrotropin [CS]",
"Status": "Active",
"LastUpdate": "2023-03-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19981130",
"SamplePackage": "N",
"IndicationAndUsage": "THYROGEN® is a thyroid stimulating hormone indicated for: 1 Adjunctive Diagnostic Tool for Well-Differentiated Thyroid Cancer: Use as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer who have previously undergone thyroidectomy. (1.1)Limitations of Use:THYROGEN-stimulated Tg levels are generally lower than, and do not correlate with Tg levels after thyroid hormone withdrawal.Even when THYROGEN-Tg testing is performed in combination with radioiodine imaging, there remains a risk of missing a diagnosis of thyroid cancer or underestimating the extent of the disease.Anti-Tg Antibodies may confound the Tg assay and render Tg levels uninterpretable., 2 Adjunct for Thyroid Remnant Ablation in Well-Differentiated Thyroid Cancer: Use as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer. (1.2)Limitations of Use:The effect of THYROGEN on thyroid cancer recurrence greater than 5 years post-remnant ablation has not been evaluated.",
"Description": "Thyrotropin alfa, a recombinant human thyroid stimulating hormone, is a heterodimeric glycoprotein comprised of two non-covalently linked subunits, an alpha subunit of 92 amino acid residues containing two N-linked glycosylation sites and a beta subunit of 118 residues containing one N-linked glycosylation site. The amino acid sequence of thyrotropin alfa is identical to that of human pituitary TSH. Thyrotropin alfa is synthesized in a genetically modified Chinese hamster ovary cell line. Both thyrotropin alfa and naturally occurring human pituitary TSH are synthesized as a mixture of glycosylation variants. Unlike pituitary TSH, which is secreted as a mixture of sialylated and sulfated forms, thyrotropin alfa is sialylated but not sulfated. The biological activity of thyrotropin alfa is determined by a cell-based bioassay. In this assay, cells expressing a functional TSH receptor and a cAMP-responsive element coupled to a heterologous reporter gene, luciferase, enable the measurement of thyrotropin alfa activity by measuring the luciferase response. The specific activity of thyrotropin alfa is determined relative to an internal Genzyme reference standard that was calibrated against the World Health Organization (WHO) human TSH reference standard. THYROGEN (thyrotropin alfa) for injection is a sterile, white to off-white lyophilized powder in a single-dose vial for intramuscular use after reconstitution. Each single-dose vial provides 0.9 mg of thyrotropin alfa, and contains mannitol (36 mg); sodium chloride (2.4 mg);sodium phosphate dibasic, heptahydrate (3.7 mg); and sodium phosphate monobasic, monohydrate (1.4 mg). After reconstitution with 1.2 mL of Sterile Water for Injection, USP, the concentration is 0.9 mg/mL with a deliverable volume of 1 mL (0.9 mg) and a pH of approximately 6.5 to 7.5."
},
{
"NDCCode": "58468-0040-1",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (58468-0040-1) / 7 mL in 1 VIAL, GLASS",
"NDC11Code": "58468-0040-01",
"ProductNDC": "58468-0040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fabrazyme",
"NonProprietaryName": "Agalsidase Beta",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20081217",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103979",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "AGALSIDASE BETA",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme [EPC], alpha-Glucosidases [CS]",
"Status": "Active",
"LastUpdate": "2025-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20081217",
"SamplePackage": "N",
"IndicationAndUsage": "FABRAZYME® is indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease.",
"Description": "Agalsidase beta is a recombinant human α-galactosidase A enzyme with the same amino acid sequence as the native enzyme. Purified agalsidase beta is a homodimeric glycoprotein with a molecular weight of approximately 100 kD. The mature protein is comprised of two subunits of 398 amino acids (approximately 51 kD), each of which contains three N-linked glycosylation sites. The enzyme α-galactosidase A catalyzes the hydrolysis of GL-3 and other α-galactyl-terminated neutral glycosphingolipids, such as galabiosylceramide and blood group B substances to ceramide dihexoside and galactose. The specific activity of agalsidase beta is approximately 70 U/mg (one unit is defined as the amount of activity that results in the hydrolysis of 1 µmole of a synthetic substrate, p-nitrophenyl-α-D-galactopyranoside, per minute under the assay conditions). Agalsidase beta is produced by recombinant DNA technology in a Chinese hamster ovary mammalian cell expression system. FABRAZYME (agalsidase beta) for injection is intended for intravenous infusion. It is supplied as a sterile, nonpyrogenic, preservative-free, white to off-white, lyophilized cake or powder for reconstitution with Sterile Water for Injection, USP. Each 35 mg vial contains 37 mg of agalsidase beta, as well as 222 mg mannitol, 20.4 mg sodium phosphate monobasic monohydrate, and 59.2 mg sodium phosphate dibasic heptahydrate. Following reconstitution as directed, 35 mg of agalsidase beta (7 mL) may be extracted from each 35 mg vial. Each 5 mg vial contains 5.5 mg of agalsidase beta, as well as 33.0 mg mannitol, 3.0 mg sodium phosphate monobasic monohydrate, and 8.8 mg sodium phosphate dibasic heptahydrate. Following reconstitution as directed, 5 mg of agalsidase beta (1 mL) may be extracted from each 5 mg vial."
},
{
"NDCCode": "58468-0041-1",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (58468-0041-1) / 1 mL in 1 VIAL, GLASS",
"NDC11Code": "58468-0041-01",
"ProductNDC": "58468-0041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fabrazyme",
"NonProprietaryName": "Agalsidase Beta",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20081217",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103979",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "AGALSIDASE BETA",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme [EPC], alpha-Glucosidases [CS]",
"Status": "Active",
"LastUpdate": "2025-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20081217",
"SamplePackage": "N",
"IndicationAndUsage": "FABRAZYME® is indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease.",
"Description": "Agalsidase beta is a recombinant human α-galactosidase A enzyme with the same amino acid sequence as the native enzyme. Purified agalsidase beta is a homodimeric glycoprotein with a molecular weight of approximately 100 kD. The mature protein is comprised of two subunits of 398 amino acids (approximately 51 kD), each of which contains three N-linked glycosylation sites. The enzyme α-galactosidase A catalyzes the hydrolysis of GL-3 and other α-galactyl-terminated neutral glycosphingolipids, such as galabiosylceramide and blood group B substances to ceramide dihexoside and galactose. The specific activity of agalsidase beta is approximately 70 U/mg (one unit is defined as the amount of activity that results in the hydrolysis of 1 µmole of a synthetic substrate, p-nitrophenyl-α-D-galactopyranoside, per minute under the assay conditions). Agalsidase beta is produced by recombinant DNA technology in a Chinese hamster ovary mammalian cell expression system. FABRAZYME (agalsidase beta) for injection is intended for intravenous infusion. It is supplied as a sterile, nonpyrogenic, preservative-free, white to off-white, lyophilized cake or powder for reconstitution with Sterile Water for Injection, USP. Each 35 mg vial contains 37 mg of agalsidase beta, as well as 222 mg mannitol, 20.4 mg sodium phosphate monobasic monohydrate, and 59.2 mg sodium phosphate dibasic heptahydrate. Following reconstitution as directed, 35 mg of agalsidase beta (7 mL) may be extracted from each 35 mg vial. Each 5 mg vial contains 5.5 mg of agalsidase beta, as well as 33.0 mg mannitol, 3.0 mg sodium phosphate monobasic monohydrate, and 8.8 mg sodium phosphate dibasic heptahydrate. Following reconstitution as directed, 5 mg of agalsidase beta (1 mL) may be extracted from each 5 mg vial."
},
{
"NDCCode": "58468-0070-1",
"PackageDescription": "5 mL in 1 VIAL, GLASS (58468-0070-1) ",
"NDC11Code": "58468-0070-01",
"ProductNDC": "58468-0070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aldurazyme",
"NonProprietaryName": "Laronidase",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20030430",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125058",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "LARONIDASE",
"StrengthNumber": "2.9",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC], alpha-Glucosidases [CS]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20030430",
"SamplePackage": "N",
"IndicationAndUsage": "ALDURAZYME® is indicated for the treatment of: 1 adult and pediatric patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and , 2 patients with the Scheie form of MPS I who have moderate to severe symptoms.",
"Description": "ALDURAZYME (laronidase) is a polymorphic variant of the human enzyme α-L-iduronidase that is produced by recombinant DNA technology in a Chinese hamster ovary cell line. α-L-iduronidase (glycosaminoglycan α-L-iduronohydrolase, EC 3.2.1.76) is a lysosomal hydrolase that catalyzes the hydrolysis of terminal α-L-iduronic acid residues of dermatan sulfate and heparan sulfate. Laronidase is a glycoprotein with a molecular weight of approximately 83 kD. The predicted amino acid sequence of the recombinant form, as well as the nucleotide sequence that encodes it, are identical to a polymorphic form of human α-L-iduronidase. The recombinant protein is comprised of 628 amino acids after cleavage of the N-terminus and contains 6 N-linked oligosaccharide modification sites. Two oligosaccharide chains terminate in mannose-6-phosphate sugars. ALDURAZYME has a specific activity of approximately 172 U/mg. ALDURAZYME, for intravenous infusion, is supplied as a sterile, nonpyrogenic, colorless to pale yellow, clear to slightly opalescent solution that must be diluted prior to administration in 0.9% Sodium Chloride Injection, USP. The solution in each vial contains a nominal laronidase concentration of 0.58 mg/mL and a pH of approximately 5.5. The extractable volume of 5 mL from each vial provides 2.9 mg laronidase, 43.9 mg sodium chloride, 63.5 mg sodium phosphate monobasic monohydrate, 10.7 mg sodium phosphate dibasic heptahydrate, and 0.05 mg polysorbate 80. ALDURAZYME does not contain preservatives; vials are for single dose only."
},
{
"NDCCode": "58468-0130-1",
"PackageDescription": "270 TABLET, FILM COATED in 1 BOTTLE (58468-0130-1) ",
"NDC11Code": "58468-0130-01",
"ProductNDC": "58468-0130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Renvela",
"NonProprietaryName": "Sevelamer Carbonate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090812",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022127",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "SEVELAMER CARBONATE",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090812",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "Renvela ®(sevelamer carbonate) is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.",
"Description": "The active ingredient in Renvela is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride (Renagel ®). Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate binding, is the same. Renvela (sevelamer carbonate) is known chemically as poly(allylamine- co-N,N′-diallyl-1,3-diamino-2-hydroxypropane) carbonate salt. Sevelamer carbonate is hygroscopic, but insoluble in water. The structure is represented in Figure 1."
},
{
"NDCCode": "58468-0131-2",
"PackageDescription": "90 PACKET in 1 CARTON (58468-0131-2) / 1 POWDER, FOR SUSPENSION in 1 PACKET (58468-0131-1) ",
"NDC11Code": "58468-0131-02",
"ProductNDC": "58468-0131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Renvela",
"NonProprietaryName": "Sevelamer Carbonate",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20090812",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022318",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "SEVELAMER CARBONATE",
"StrengthNumber": "2400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090812",
"SamplePackage": "N",
"IndicationAndUsage": "Renvela ®(sevelamer carbonate) is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.",
"Description": "The active ingredient in Renvela is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride (Renagel ®). Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate binding, is the same. Renvela (sevelamer carbonate) is known chemically as poly(allylamine- co-N,N′-diallyl-1,3-diamino-2-hydroxypropane) carbonate salt. Sevelamer carbonate is hygroscopic, but insoluble in water. The structure is represented in Figure 1."
},
{
"NDCCode": "58468-0132-2",
"PackageDescription": "90 PACKET in 1 CARTON (58468-0132-2) / 1 POWDER, FOR SUSPENSION in 1 PACKET (58468-0132-1) ",
"NDC11Code": "58468-0132-02",
"ProductNDC": "58468-0132",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Renvela",
"NonProprietaryName": "Sevelamer Carbonate",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20090812",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022318",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "SEVELAMER CARBONATE",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20090812",
"SamplePackage": "N",
"IndicationAndUsage": "Renvela ®(sevelamer carbonate) is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.",
"Description": "The active ingredient in Renvela is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride (Renagel ®). Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate binding, is the same. Renvela (sevelamer carbonate) is known chemically as poly(allylamine- co-N,N′-diallyl-1,3-diamino-2-hydroxypropane) carbonate salt. Sevelamer carbonate is hygroscopic, but insoluble in water. The structure is represented in Figure 1."
},
{
"NDCCode": "58468-0133-1",
"PackageDescription": "270 TABLET, FILM COATED in 1 BOTTLE (58468-0133-1) ",
"NDC11Code": "58468-0133-01",
"ProductNDC": "58468-0133",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Renvela",
"NonProprietaryName": "Sevelamer Carbonate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090812",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022127",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "SEVELAMER CARBONATE",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230714",
"SamplePackage": "N",
"IndicationAndUsage": "Renvela ®(sevelamer carbonate) is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.",
"Description": "The active ingredient in Renvela is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride (Renagel ®). Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate binding, is the same. Renvela (sevelamer carbonate) is known chemically as poly(allylamine- co-N,N′-diallyl-1,3-diamino-2-hydroxypropane) carbonate salt. Sevelamer carbonate is hygroscopic, but insoluble in water. The structure is represented in Figure 1."
},
{
"NDCCode": "58468-0160-1",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (58468-0160-1) / 10.5 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "58468-0160-01",
"ProductNDC": "58468-0160",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lumizyme",
"NonProprietaryName": "Alglucosidase Alfa",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20100524",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125291",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "ALGLUCOSIDASE ALFA",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Hydrolytic Lysosomal Glycogen-specific Enzyme [EPC], alpha-Glucosidases [CS]",
"Status": "Active",
"LastUpdate": "2025-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100524",
"SamplePackage": "N",
"IndicationAndUsage": "LUMIZYME® is a hydrolytic lysosomal glycogen-specific enzyme indicated for patients with Pompe disease (acid α-glucosidase [GAA] deficiency).",
"Description": "Alglucosidase alfa is a hydrolytic lysosomal glycogen-specific enzyme encoded by the predominant of nine observed haplotypes of the human acid α-glucosidase (GAA) gene. Alglucosidase alfa is produced by recombinant DNA technology in a Chinese hamster ovary cell line. Alglucosidase alfa degrades glycogen by catalyzing the hydrolysis of α-1,4- and α-1,6- glycosidic linkages of lysosomal glycogen. Alglucosidase alfa is a glycoprotein with a calculated mass of 99,377 Daltons for the polypeptide chain, and a total mass of approximately 109,000 Daltons, including carbohydrates. Alglucosidase alfa has a specific activity of 3.6 to 5.4 units/mg (one unit is defined as that amount of activity that results in the hydrolysis of 1 micromole of synthetic substrate per minute under specified assay conditions). Alglucosidase alfa is intended for intravenous infusion. It is supplied as a sterile, nonpyrogenic, white to off-white, lyophilized cake or powder for reconstitution with 10.3 mL Sterile Water for Injection, USP. Each 50 mg vial contains 52.5 mg alglucosidase alfa, 210 mg mannitol, 0.5 mg polysorbate 80, 9.9 mg sodium phosphate dibasic heptahydrate, and 31.2 mg sodium phosphate monobasic monohydrate. Following reconstitution as directed, each vial contains 10.5 mL reconstituted solution and a total extractable volume of 10 mL at 5 mg/mL alglucosidase alfa. Alglucosidase alfa does not contain preservatives; each vial is for single dose only."
},
{
"NDCCode": "58468-0210-1",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (58468-0210-1) / 5 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "58468-0210-01",
"ProductNDC": "58468-0210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aubagio",
"NonProprietaryName": "Teriflunomide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202992",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "TERIFLUNOMIDE",
"StrengthNumber": "14",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130501",
"SamplePackage": "N",
"IndicationAndUsage": "AUBAGIO® is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "AUBAGIO (teriflunomide) is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white to almost white powder that is sparingly soluble in acetone, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. AUBAGIO tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: lactose monohydrate, corn starch, hydroxypropyl cellulose, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate. The film coating for the 14 mg tablet is made of hypromellose, titanium dioxide, talc, polyethylene glycol and indigo carmine aluminum lake. In addition to these, the 7 mg tablet film coating includes iron oxide yellow."
},
{
"NDCCode": "58468-0210-4",
"PackageDescription": "1 BOTTLE in 1 CARTON (58468-0210-4) / 30 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "58468-0210-04",
"ProductNDC": "58468-0210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aubagio",
"NonProprietaryName": "Teriflunomide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202992",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "TERIFLUNOMIDE",
"StrengthNumber": "14",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190328",
"SamplePackage": "N",
"IndicationAndUsage": "AUBAGIO® is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "AUBAGIO (teriflunomide) is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white to almost white powder that is sparingly soluble in acetone, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. AUBAGIO tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: lactose monohydrate, corn starch, hydroxypropyl cellulose, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate. The film coating for the 14 mg tablet is made of hypromellose, titanium dioxide, talc, polyethylene glycol and indigo carmine aluminum lake. In addition to these, the 7 mg tablet film coating includes iron oxide yellow."
},
{
"NDCCode": "58468-0211-2",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (58468-0211-2) / 5 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "58468-0211-02",
"ProductNDC": "58468-0211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aubagio",
"NonProprietaryName": "Teriflunomide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202992",
"LabelerName": "Genzyme Corporation",
"SubstanceName": "TERIFLUNOMIDE",
"StrengthNumber": "7",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130501",
"SamplePackage": "N",
"IndicationAndUsage": "AUBAGIO® is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "AUBAGIO (teriflunomide) is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white to almost white powder that is sparingly soluble in acetone, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. AUBAGIO tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: lactose monohydrate, corn starch, hydroxypropyl cellulose, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate. The film coating for the 14 mg tablet is made of hypromellose, titanium dioxide, talc, polyethylene glycol and indigo carmine aluminum lake. In addition to these, the 7 mg tablet film coating includes iron oxide yellow."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>58468-7820-3</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (58468-7820-3) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>58468-7820-03</NDC11Code>
<ProductNDC>58468-7820</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Caprelsa</ProprietaryName>
<NonProprietaryName>Vandetanib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110725</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022405</ApplicationNumber>
<LabelerName>Genzyme Corporation</LabelerName>
<SubstanceName>VANDETANIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CAPRELSA is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA.</IndicationAndUsage>
<Description>Vandetanib has the chemical name N-(4-bromo-2-fluorophenyl)-6-methoxy-7-[(1-methylpiperidin-4-yl) methoxy]quinazolin-4-amine. The structural and molecular formulas are. C22H24BrFN4O2. Vandetanib has a molecular weight of 475.36 g/mol. Vandetanib exhibits pH-dependent solubility, with increased solubility at lower pH. Vandetanib is practically insoluble in water with a value of 0.008 mg/mL at 25°C (77°F). CAPRELSA tablets for daily oral administration are available in two dosage strengths containing either 100 mg or 300 mg of vandetanib. The tablet cores contain the following inactive ingredients: calcium hydrogen phosphate dihydrate, crospovidone, magnesium stearate, microcrystalline cellulose, and povidone. The tablet film-coat contains the following inactive ingredients: hypromellose 2910, macrogol 300, and titanium dioxide E171.</Description>
</NDC>
<NDC>
<NDCCode>63629-7820-3</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7820-3) </PackageDescription>
<NDC11Code>63629-7820-03</NDC11Code>
<ProductNDC>63629-7820</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Xl</ProprietaryNameSuffix>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207224</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (XL) is an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient. (1).</IndicationAndUsage>
<Description>Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is. Bupropion hydrochloride extended-release tablets (XL) are supplied for oral administration as 150 mg and 300 mg white, round, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: colloidal silicon dioxide, copovidone, ethyl cellulose, hydroxypropyl cellulose, glyceryl behenate, methacrylic acid copolymer and silicon dioxide. The tablets are printed with edible black ink. The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces. USP dissolution test is pending.</Description>
</NDC>
<NDC>
<NDCCode>68788-7820-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-7820-3) </PackageDescription>
<NDC11Code>68788-7820-03</NDC11Code>
<ProductNDC>68788-7820</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201113</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077284</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58468-0021-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (58468-0021-3)</PackageDescription>
<NDC11Code>58468-0021-03</NDC11Code>
<ProductNDC>58468-0021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Renagel</ProprietaryName>
<NonProprietaryName>Renagel</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080606</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021179</ApplicationNumber>
<LabelerName>Genzyme Corporation</LabelerName>
<SubstanceName>SEVELAMER HYDROCHLORIDE</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-20</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>58468-0121-3</NDCCode>
<PackageDescription>7 CAPSULE, LIQUID FILLED in 1 BOTTLE (58468-0121-3) </PackageDescription>
<NDC11Code>58468-0121-03</NDC11Code>
<ProductNDC>58468-0121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hectorol</ProprietaryName>
<NonProprietaryName>Doxercalciferol</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090803</StartMarketingDate>
<EndMarketingDate>20190131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020862</ApplicationNumber>
<LabelerName>Genzyme Corporation</LabelerName>
<SubstanceName>DOXERCALCIFEROL</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Ergocalciferols [CS],Vitamin D2 Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090803</StartMarketingDatePackage>
<EndMarketingDatePackage>20190131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58468-0124-3</NDCCode>
<PackageDescription>7 CAPSULE, LIQUID FILLED in 1 BOTTLE (58468-0124-3) </PackageDescription>
<NDC11Code>58468-0124-03</NDC11Code>
<ProductNDC>58468-0124</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hectorol</ProprietaryName>
<NonProprietaryName>Doxercalciferol</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090803</StartMarketingDate>
<EndMarketingDate>20190131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020862</ApplicationNumber>
<LabelerName>Genzyme Corporation</LabelerName>
<SubstanceName>DOXERCALCIFEROL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Ergocalciferols [CS],Vitamin D2 Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090803</StartMarketingDatePackage>
<EndMarketingDatePackage>20190131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58468-0131-4</NDCCode>
<PackageDescription>90 PACKET in 1 CARTON (58468-0131-4) > 1 POWDER, FOR SUSPENSION in 1 PACKET (58468-0131-3) </PackageDescription>
<NDC11Code>58468-0131-04</NDC11Code>
<ProductNDC>58468-0131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Renvela</ProprietaryName>
<NonProprietaryName>Sevelamer Carbonate</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090812</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022318</ApplicationNumber>
<LabelerName>Genzyme Corporation</LabelerName>
<SubstanceName>SEVELAMER CARBONATE</SubstanceName>
<StrengthNumber>2400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090812</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58468-0131-5</NDCCode>
<PackageDescription>15 PACKET in 1 CARTON (58468-0131-5) > 1 POWDER, FOR SUSPENSION in 1 PACKET (58468-0131-3) </PackageDescription>
<NDC11Code>58468-0131-05</NDC11Code>
<ProductNDC>58468-0131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Renvela</ProprietaryName>
<NonProprietaryName>Sevelamer Carbonate</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090812</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022318</ApplicationNumber>
<LabelerName>Genzyme Corporation</LabelerName>
<SubstanceName>SEVELAMER CARBONATE</SubstanceName>
<StrengthNumber>2400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090812</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58468-0210-3</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (58468-0210-3) / 5 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>58468-0210-03</NDC11Code>
<ProductNDC>58468-0210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aubagio</ProprietaryName>
<NonProprietaryName>Teriflunomide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202992</ApplicationNumber>
<LabelerName>Genzyme Corporation</LabelerName>
<SubstanceName>TERIFLUNOMIDE</SubstanceName>
<StrengthNumber>14</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130501</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>AUBAGIO® is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>AUBAGIO (teriflunomide) is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white to almost white powder that is sparingly soluble in acetone, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. AUBAGIO tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: lactose monohydrate, corn starch, hydroxypropyl cellulose, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate. The film coating for the 14 mg tablet is made of hypromellose, titanium dioxide, talc, polyethylene glycol and indigo carmine aluminum lake. In addition to these, the 7 mg tablet film coating includes iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>58468-0211-3</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (58468-0211-3) / 5 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>58468-0211-03</NDC11Code>
<ProductNDC>58468-0211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aubagio</ProprietaryName>
<NonProprietaryName>Teriflunomide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202992</ApplicationNumber>
<LabelerName>Genzyme Corporation</LabelerName>
<SubstanceName>TERIFLUNOMIDE</SubstanceName>
<StrengthNumber>7</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130501</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>AUBAGIO® is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>AUBAGIO (teriflunomide) is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white to almost white powder that is sparingly soluble in acetone, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. AUBAGIO tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: lactose monohydrate, corn starch, hydroxypropyl cellulose, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate. The film coating for the 14 mg tablet is made of hypromellose, titanium dioxide, talc, polyethylene glycol and indigo carmine aluminum lake. In addition to these, the 7 mg tablet film coating includes iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>58468-0357-3</NDCCode>
<PackageDescription>3 VIAL, SINGLE-USE in 1 CARTON (58468-0357-3) / 1 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>58468-0357-03</NDC11Code>
<ProductNDC>58468-0357</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Campath</ProprietaryName>
<NonProprietaryName>Alemtuzumab</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091130</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103948</ApplicationNumber>
<LabelerName>Genzyme Corporation</LabelerName>
<SubstanceName>ALEMTUZUMAB</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>CD52-directed Antibody Interactions [MoA], CD52-directed Cytolytic Antibody [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).</IndicationAndUsage>
<Description>Alemtuzumab, a CD52-directed cytolytic antibody, is a recombinant DNA-derived humanized monoclonal antibody (CAMPATH-1H). CAMPATH-1H is an IgG1 kappa antibody with human variable framework and constant regions, and complementarity-determining regions from a murine (rat) monoclonal antibody (CAMPATH-1G). The CAMPATH-1H antibody has an approximate molecular weight of 150 kD. CAMPATH is produced in mammalian cell (Chinese hamster ovary) suspension culture in a medium containing neomycin. Neomycin is not detectable in the final product. CAMPATH (alemtuzumab) injection is a sterile, clear, colorless, isotonic solution (pH 6.8–7.4) in a single-dose vial for intravenous use. Each single-dose vial of CAMPATH contains 30 mg alemtuzumab, 8.0 mg sodium chloride, 1.44 mg dibasic sodium phosphate, 0.2 mg potassium chloride, 0.2 mg monobasic potassium phosphate, 0.1 mg polysorbate 80, and 0.0187 mg disodium edetate dihydrate. No preservatives are added.</Description>
</NDC>
<NDC>
<NDCCode>58468-7840-3</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (58468-7840-3) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>58468-7840-03</NDC11Code>
<ProductNDC>58468-7840</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Caprelsa</ProprietaryName>
<NonProprietaryName>Vandetanib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110725</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022405</ApplicationNumber>
<LabelerName>Genzyme Corporation</LabelerName>
<SubstanceName>VANDETANIB</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CAPRELSA is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA.</IndicationAndUsage>
<Description>Vandetanib has the chemical name N-(4-bromo-2-fluorophenyl)-6-methoxy-7-[(1-methylpiperidin-4-yl) methoxy]quinazolin-4-amine. The structural and molecular formulas are. C22H24BrFN4O2. Vandetanib has a molecular weight of 475.36 g/mol. Vandetanib exhibits pH-dependent solubility, with increased solubility at lower pH. Vandetanib is practically insoluble in water with a value of 0.008 mg/mL at 25°C (77°F). CAPRELSA tablets for daily oral administration are available in two dosage strengths containing either 100 mg or 300 mg of vandetanib. The tablet cores contain the following inactive ingredients: calcium hydrogen phosphate dihydrate, crospovidone, magnesium stearate, microcrystalline cellulose, and povidone. The tablet film-coat contains the following inactive ingredients: hypromellose 2910, macrogol 300, and titanium dioxide E171.</Description>
</NDC>
<NDC>
<NDCCode>58468-7860-3</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (58468-7860-3) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>58468-7860-03</NDC11Code>
<ProductNDC>58468-7860</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Caprelsa</ProprietaryName>
<NonProprietaryName>Vandetanib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220624</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE</MarketingCategoryName>
<LabelerName>Genzyme Corporation</LabelerName>
<SubstanceName>VANDETANIB</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0169-7820-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0169-7820-01) * 4 mL in 1 VIAL, GLASS (0169-7821-11) * 4 mL in 1 SYRINGE, GLASS (0169-7008-98) </PackageDescription>
<NDC11Code>00169-7820-01</NDC11Code>
<ProductNDC>0169-7820</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Novoeight</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20150401</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125466</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Novoeight, Antihemophilic Factor (Recombinant), is a human antihemophilic factor (human blood coagulation. factor VIII (FVIII)) indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes , 2 Perioperative management , 3 Routine prophylaxis to reduce the frequency of bleeding episodes .</IndicationAndUsage>
<Description>Novoeight is formulated as a sterile, non-pyrogenic, lyophilized powder for intravenous injection after reconstitution with the diluent (0.9% sodium chloride). Novoeight is available in single-dose vials that contain nominally 250, 500, 1000, 1500, 2000 or 3000 international units (IU) per vial. When reconstituted with the appropriate volume of diluent, the product contains the following components per mL: 18 mg sodium chloride, 1.5 mg L-histidine, 3 mg sucrose, 0.1 mg polysorbate 80, 0.055 mg L-methionine and 0.25 mg calcium chloride dihydrate. The product contains no preservative. Each vial of Novoeight is labeled with the actual rFVIII activity expressed in IU determined by the one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for FVIII Concentrates. One IU, as defined by the WHO standard for human FVIII, is approximately equal to the level of FVIII activity in 1 mL of fresh pooled human plasma. The specific activity of Novoeight is approximately 8340 IU per milligram of protein. The active ingredient in Novoeight is a recombinant (r) analogue of human coagulation factor VIII (FVIII) with a molecular mass of 166 kDa, calculated excluding post-translational modifications. The rFVIII molecule in Novoeight is a glycoprotein containing a heavy chain and a light chain, with 21 of the 908 amino acids of the B-domain of endogenous FVIII connected to the C-terminus of the heavy chain. Once activated, the resulting rFVIIIa has a comparable structure to the endogenous FVIIIa. Novoeight is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line which secretes rFVIII into the cell culture medium. The rFVIII protein is purified using a series of chromatography steps, one of which is the use of an immunoaffinity column in which a monoclonal antibody, produced in CHO cells and directed against FVIII, is employed to selectively isolate the rFVIII from the medium. The production process includes two dedicated viral clearance steps - a detergent treatment step for inactivation and a 20-nm filtration step for removal of viruses. No additives of human or animal origin are used in the cell culture, purification and formulation of Novoeight.</Description>
</NDC>
<NDC>
<NDCCode>0480-7820-56</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0480-7820-56) </PackageDescription>
<NDC11Code>00480-7820-56</NDC11Code>
<ProductNDC>0480-7820</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fingolimod</ProprietaryName>
<NonProprietaryName>Fingolimod</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208008</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FINGOLIMOD HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.</IndicationAndUsage>
<Description>Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below. Fingolimod hydrochloride, USP is a white to off-white solid that is freely soluble in water and alcohol and soluble in propylene glycol. It has a molecular weight of 343.93 g/mol. Fingolimod is provided as 0.5 mg hard gelatin capsules for oral use. Each 0.5 mg capsule contains 0.56 mg of fingolimod hydrochloride USP, equivalent to 0.5 mg of fingolimod. Each capsule contains the following inactive ingredients: pregelatinized starch (corn) and sodium lauryl sulfate. The capsule shell contains gelatin, iron oxide yellow, and titanium dioxide. In addition, the imprinting ink contains the following: black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>50090-7820-0</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (50090-7820-0) </PackageDescription>
<NDC11Code>50090-7820-00</NDC11Code>
<ProductNDC>50090-7820</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091491</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (green), 750 mg (pink), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide and additional agents listed below. 250 mg tablets: FD&C Blue #2/indigo carmine aluminum lake. 500 mg tablets: D&C Yellow #10/aluminum lake and FD&C Blue #1/brilliant blue FCF aluminum lake. 750 mg tablets: FD&C Red #40/alura red AC aluminum lake, FD&C Yellow #6/sunset yellow FCF aluminum lake, and FD&C Blue #1/brilliant blue FCF aluminum lake. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>50090-7820-1</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (50090-7820-1) </PackageDescription>
<NDC11Code>50090-7820-01</NDC11Code>
<ProductNDC>50090-7820</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091491</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (green), 750 mg (pink), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). Levetiracetam tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide and additional agents listed below. 250 mg tablets: FD&C Blue #2/indigo carmine aluminum lake. 500 mg tablets: D&C Yellow #10/aluminum lake and FD&C Blue #1/brilliant blue FCF aluminum lake. 750 mg tablets: FD&C Red #40/alura red AC aluminum lake, FD&C Yellow #6/sunset yellow FCF aluminum lake, and FD&C Blue #1/brilliant blue FCF aluminum lake. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>58468-0021-1</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58468-0021-1) </PackageDescription>
<NDC11Code>58468-0021-01</NDC11Code>
<ProductNDC>58468-0021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Renagel</ProprietaryName>
<NonProprietaryName>Sevelamer Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080606</StartMarketingDate>
<EndMarketingDate>20240131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021179</ApplicationNumber>
<LabelerName>Genzyme Corporation</LabelerName>
<SubstanceName>SEVELAMER HYDROCHLORIDE</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20080606</StartMarketingDatePackage>
<EndMarketingDatePackage>20240131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Renagel ®is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of Renagel in CKD patients who are not on dialysis have not been studied.</IndicationAndUsage>
<Description>The active ingredient in Renagel tablets is sevelamer hydrochloride, a polymeric amine that binds phosphate and is meant for oral administration. Sevelamer hydrochloride is poly(allylamine hydrochloride) crosslinked with epichlorohydrin in which 40% of the amines are protonated. It is known chemically as poly(allylamine- co-N,N'-diallyl-1,3-diamino-2-hydroxypropane) hydrochloride. Sevelamer hydrochloride is hydrophilic, but insoluble in water. The structure is represented in Figure 1. Figure 1: Chemical Structure of Sevelamer Hydrochloride. The primary amine groups shown in the structure are derived directly from poly(allylamine hydrochloride). The crosslinking groups consist of two secondary amine groups derived from poly(allylamine hydrochloride) and one molecule of epichlorohydrin.</Description>
</NDC>
<NDC>
<NDCCode>58468-0030-2</NDCCode>
<PackageDescription>2 VIAL, SINGLE-DOSE in 1 CARTON (58468-0030-2) / 1 mL in 1 VIAL, SINGLE-DOSE (58468-0030-1) </PackageDescription>
<NDC11Code>58468-0030-02</NDC11Code>
<ProductNDC>58468-0030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Thyrogen</ProprietaryName>
<NonProprietaryName>Thyrotropin Alfa</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>19981130</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA020898</ApplicationNumber>
<LabelerName>Genzyme Corporation</LabelerName>
<SubstanceName>THYROTROPIN ALFA</SubstanceName>
<StrengthNumber>.9</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Thyroid Stimulating Hormone [EPC], Thyrotropin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19981130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>THYROGEN® is a thyroid stimulating hormone indicated for: 1 Adjunctive Diagnostic Tool for Well-Differentiated Thyroid Cancer: Use as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer who have previously undergone thyroidectomy. (1.1)Limitations of Use:THYROGEN-stimulated Tg levels are generally lower than, and do not correlate with Tg levels after thyroid hormone withdrawal.Even when THYROGEN-Tg testing is performed in combination with radioiodine imaging, there remains a risk of missing a diagnosis of thyroid cancer or underestimating the extent of the disease.Anti-Tg Antibodies may confound the Tg assay and render Tg levels uninterpretable., 2 Adjunct for Thyroid Remnant Ablation in Well-Differentiated Thyroid Cancer: Use as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer. (1.2)Limitations of Use:The effect of THYROGEN on thyroid cancer recurrence greater than 5 years post-remnant ablation has not been evaluated.</IndicationAndUsage>
<Description>Thyrotropin alfa, a recombinant human thyroid stimulating hormone, is a heterodimeric glycoprotein comprised of two non-covalently linked subunits, an alpha subunit of 92 amino acid residues containing two N-linked glycosylation sites and a beta subunit of 118 residues containing one N-linked glycosylation site. The amino acid sequence of thyrotropin alfa is identical to that of human pituitary TSH. Thyrotropin alfa is synthesized in a genetically modified Chinese hamster ovary cell line. Both thyrotropin alfa and naturally occurring human pituitary TSH are synthesized as a mixture of glycosylation variants. Unlike pituitary TSH, which is secreted as a mixture of sialylated and sulfated forms, thyrotropin alfa is sialylated but not sulfated. The biological activity of thyrotropin alfa is determined by a cell-based bioassay. In this assay, cells expressing a functional TSH receptor and a cAMP-responsive element coupled to a heterologous reporter gene, luciferase, enable the measurement of thyrotropin alfa activity by measuring the luciferase response. The specific activity of thyrotropin alfa is determined relative to an internal Genzyme reference standard that was calibrated against the World Health Organization (WHO) human TSH reference standard. THYROGEN (thyrotropin alfa) for injection is a sterile, white to off-white lyophilized powder in a single-dose vial for intramuscular use after reconstitution. Each single-dose vial provides 0.9 mg of thyrotropin alfa, and contains mannitol (36 mg); sodium chloride (2.4 mg);sodium phosphate dibasic, heptahydrate (3.7 mg); and sodium phosphate monobasic, monohydrate (1.4 mg). After reconstitution with 1.2 mL of Sterile Water for Injection, USP, the concentration is 0.9 mg/mL with a deliverable volume of 1 mL (0.9 mg) and a pH of approximately 6.5 to 7.5.</Description>
</NDC>
<NDC>
<NDCCode>58468-0040-1</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (58468-0040-1) / 7 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>58468-0040-01</NDC11Code>
<ProductNDC>58468-0040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fabrazyme</ProprietaryName>
<NonProprietaryName>Agalsidase Beta</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20081217</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103979</ApplicationNumber>
<LabelerName>Genzyme Corporation</LabelerName>
<SubstanceName>AGALSIDASE BETA</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme [EPC], alpha-Glucosidases [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FABRAZYME® is indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease.</IndicationAndUsage>
<Description>Agalsidase beta is a recombinant human α-galactosidase A enzyme with the same amino acid sequence as the native enzyme. Purified agalsidase beta is a homodimeric glycoprotein with a molecular weight of approximately 100 kD. The mature protein is comprised of two subunits of 398 amino acids (approximately 51 kD), each of which contains three N-linked glycosylation sites. The enzyme α-galactosidase A catalyzes the hydrolysis of GL-3 and other α-galactyl-terminated neutral glycosphingolipids, such as galabiosylceramide and blood group B substances to ceramide dihexoside and galactose. The specific activity of agalsidase beta is approximately 70 U/mg (one unit is defined as the amount of activity that results in the hydrolysis of 1 µmole of a synthetic substrate, p-nitrophenyl-α-D-galactopyranoside, per minute under the assay conditions). Agalsidase beta is produced by recombinant DNA technology in a Chinese hamster ovary mammalian cell expression system. FABRAZYME (agalsidase beta) for injection is intended for intravenous infusion. It is supplied as a sterile, nonpyrogenic, preservative-free, white to off-white, lyophilized cake or powder for reconstitution with Sterile Water for Injection, USP. Each 35 mg vial contains 37 mg of agalsidase beta, as well as 222 mg mannitol, 20.4 mg sodium phosphate monobasic monohydrate, and 59.2 mg sodium phosphate dibasic heptahydrate. Following reconstitution as directed, 35 mg of agalsidase beta (7 mL) may be extracted from each 35 mg vial. Each 5 mg vial contains 5.5 mg of agalsidase beta, as well as 33.0 mg mannitol, 3.0 mg sodium phosphate monobasic monohydrate, and 8.8 mg sodium phosphate dibasic heptahydrate. Following reconstitution as directed, 5 mg of agalsidase beta (1 mL) may be extracted from each 5 mg vial.</Description>
</NDC>
<NDC>
<NDCCode>58468-0041-1</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (58468-0041-1) / 1 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>58468-0041-01</NDC11Code>
<ProductNDC>58468-0041</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fabrazyme</ProprietaryName>
<NonProprietaryName>Agalsidase Beta</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20081217</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103979</ApplicationNumber>
<LabelerName>Genzyme Corporation</LabelerName>
<SubstanceName>AGALSIDASE BETA</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme [EPC], alpha-Glucosidases [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FABRAZYME® is indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease.</IndicationAndUsage>
<Description>Agalsidase beta is a recombinant human α-galactosidase A enzyme with the same amino acid sequence as the native enzyme. Purified agalsidase beta is a homodimeric glycoprotein with a molecular weight of approximately 100 kD. The mature protein is comprised of two subunits of 398 amino acids (approximately 51 kD), each of which contains three N-linked glycosylation sites. The enzyme α-galactosidase A catalyzes the hydrolysis of GL-3 and other α-galactyl-terminated neutral glycosphingolipids, such as galabiosylceramide and blood group B substances to ceramide dihexoside and galactose. The specific activity of agalsidase beta is approximately 70 U/mg (one unit is defined as the amount of activity that results in the hydrolysis of 1 µmole of a synthetic substrate, p-nitrophenyl-α-D-galactopyranoside, per minute under the assay conditions). Agalsidase beta is produced by recombinant DNA technology in a Chinese hamster ovary mammalian cell expression system. FABRAZYME (agalsidase beta) for injection is intended for intravenous infusion. It is supplied as a sterile, nonpyrogenic, preservative-free, white to off-white, lyophilized cake or powder for reconstitution with Sterile Water for Injection, USP. Each 35 mg vial contains 37 mg of agalsidase beta, as well as 222 mg mannitol, 20.4 mg sodium phosphate monobasic monohydrate, and 59.2 mg sodium phosphate dibasic heptahydrate. Following reconstitution as directed, 35 mg of agalsidase beta (7 mL) may be extracted from each 35 mg vial. Each 5 mg vial contains 5.5 mg of agalsidase beta, as well as 33.0 mg mannitol, 3.0 mg sodium phosphate monobasic monohydrate, and 8.8 mg sodium phosphate dibasic heptahydrate. Following reconstitution as directed, 5 mg of agalsidase beta (1 mL) may be extracted from each 5 mg vial.</Description>
</NDC>
<NDC>
<NDCCode>58468-0070-1</NDCCode>
<PackageDescription>5 mL in 1 VIAL, GLASS (58468-0070-1) </PackageDescription>
<NDC11Code>58468-0070-01</NDC11Code>
<ProductNDC>58468-0070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aldurazyme</ProprietaryName>
<NonProprietaryName>Laronidase</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20030430</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125058</ApplicationNumber>
<LabelerName>Genzyme Corporation</LabelerName>
<SubstanceName>LARONIDASE</SubstanceName>
<StrengthNumber>2.9</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC], alpha-Glucosidases [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ALDURAZYME® is indicated for the treatment of: 1 adult and pediatric patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and , 2 patients with the Scheie form of MPS I who have moderate to severe symptoms.</IndicationAndUsage>
<Description>ALDURAZYME (laronidase) is a polymorphic variant of the human enzyme α-L-iduronidase that is produced by recombinant DNA technology in a Chinese hamster ovary cell line. α-L-iduronidase (glycosaminoglycan α-L-iduronohydrolase, EC 3.2.1.76) is a lysosomal hydrolase that catalyzes the hydrolysis of terminal α-L-iduronic acid residues of dermatan sulfate and heparan sulfate. Laronidase is a glycoprotein with a molecular weight of approximately 83 kD. The predicted amino acid sequence of the recombinant form, as well as the nucleotide sequence that encodes it, are identical to a polymorphic form of human α-L-iduronidase. The recombinant protein is comprised of 628 amino acids after cleavage of the N-terminus and contains 6 N-linked oligosaccharide modification sites. Two oligosaccharide chains terminate in mannose-6-phosphate sugars. ALDURAZYME has a specific activity of approximately 172 U/mg. ALDURAZYME, for intravenous infusion, is supplied as a sterile, nonpyrogenic, colorless to pale yellow, clear to slightly opalescent solution that must be diluted prior to administration in 0.9% Sodium Chloride Injection, USP. The solution in each vial contains a nominal laronidase concentration of 0.58 mg/mL and a pH of approximately 5.5. The extractable volume of 5 mL from each vial provides 2.9 mg laronidase, 43.9 mg sodium chloride, 63.5 mg sodium phosphate monobasic monohydrate, 10.7 mg sodium phosphate dibasic heptahydrate, and 0.05 mg polysorbate 80. ALDURAZYME does not contain preservatives; vials are for single dose only.</Description>
</NDC>
<NDC>
<NDCCode>58468-0130-1</NDCCode>
<PackageDescription>270 TABLET, FILM COATED in 1 BOTTLE (58468-0130-1) </PackageDescription>
<NDC11Code>58468-0130-01</NDC11Code>
<ProductNDC>58468-0130</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Renvela</ProprietaryName>
<NonProprietaryName>Sevelamer Carbonate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090812</StartMarketingDate>
<EndMarketingDate>20251031</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022127</ApplicationNumber>
<LabelerName>Genzyme Corporation</LabelerName>
<SubstanceName>SEVELAMER CARBONATE</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090812</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Renvela ®(sevelamer carbonate) is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.</IndicationAndUsage>
<Description>The active ingredient in Renvela is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride (Renagel ®). Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate binding, is the same. Renvela (sevelamer carbonate) is known chemically as poly(allylamine- co-N,N′-diallyl-1,3-diamino-2-hydroxypropane) carbonate salt. Sevelamer carbonate is hygroscopic, but insoluble in water. The structure is represented in Figure 1.</Description>
</NDC>
<NDC>
<NDCCode>58468-0131-2</NDCCode>
<PackageDescription>90 PACKET in 1 CARTON (58468-0131-2) / 1 POWDER, FOR SUSPENSION in 1 PACKET (58468-0131-1) </PackageDescription>
<NDC11Code>58468-0131-02</NDC11Code>
<ProductNDC>58468-0131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Renvela</ProprietaryName>
<NonProprietaryName>Sevelamer Carbonate</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090812</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022318</ApplicationNumber>
<LabelerName>Genzyme Corporation</LabelerName>
<SubstanceName>SEVELAMER CARBONATE</SubstanceName>
<StrengthNumber>2400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090812</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Renvela ®(sevelamer carbonate) is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.</IndicationAndUsage>
<Description>The active ingredient in Renvela is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride (Renagel ®). Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate binding, is the same. Renvela (sevelamer carbonate) is known chemically as poly(allylamine- co-N,N′-diallyl-1,3-diamino-2-hydroxypropane) carbonate salt. Sevelamer carbonate is hygroscopic, but insoluble in water. The structure is represented in Figure 1.</Description>
</NDC>
<NDC>
<NDCCode>58468-0132-2</NDCCode>
<PackageDescription>90 PACKET in 1 CARTON (58468-0132-2) / 1 POWDER, FOR SUSPENSION in 1 PACKET (58468-0132-1) </PackageDescription>
<NDC11Code>58468-0132-02</NDC11Code>
<ProductNDC>58468-0132</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Renvela</ProprietaryName>
<NonProprietaryName>Sevelamer Carbonate</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090812</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022318</ApplicationNumber>
<LabelerName>Genzyme Corporation</LabelerName>
<SubstanceName>SEVELAMER CARBONATE</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090812</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Renvela ®(sevelamer carbonate) is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.</IndicationAndUsage>
<Description>The active ingredient in Renvela is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride (Renagel ®). Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate binding, is the same. Renvela (sevelamer carbonate) is known chemically as poly(allylamine- co-N,N′-diallyl-1,3-diamino-2-hydroxypropane) carbonate salt. Sevelamer carbonate is hygroscopic, but insoluble in water. The structure is represented in Figure 1.</Description>
</NDC>
<NDC>
<NDCCode>58468-0133-1</NDCCode>
<PackageDescription>270 TABLET, FILM COATED in 1 BOTTLE (58468-0133-1) </PackageDescription>
<NDC11Code>58468-0133-01</NDC11Code>
<ProductNDC>58468-0133</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Renvela</ProprietaryName>
<NonProprietaryName>Sevelamer Carbonate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090812</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022127</ApplicationNumber>
<LabelerName>Genzyme Corporation</LabelerName>
<SubstanceName>SEVELAMER CARBONATE</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Renvela ®(sevelamer carbonate) is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.</IndicationAndUsage>
<Description>The active ingredient in Renvela is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride (Renagel ®). Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate binding, is the same. Renvela (sevelamer carbonate) is known chemically as poly(allylamine- co-N,N′-diallyl-1,3-diamino-2-hydroxypropane) carbonate salt. Sevelamer carbonate is hygroscopic, but insoluble in water. The structure is represented in Figure 1.</Description>
</NDC>
<NDC>
<NDCCode>58468-0160-1</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (58468-0160-1) / 10.5 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>58468-0160-01</NDC11Code>
<ProductNDC>58468-0160</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lumizyme</ProprietaryName>
<NonProprietaryName>Alglucosidase Alfa</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20100524</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125291</ApplicationNumber>
<LabelerName>Genzyme Corporation</LabelerName>
<SubstanceName>ALGLUCOSIDASE ALFA</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Hydrolytic Lysosomal Glycogen-specific Enzyme [EPC], alpha-Glucosidases [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LUMIZYME® is a hydrolytic lysosomal glycogen-specific enzyme indicated for patients with Pompe disease (acid α-glucosidase [GAA] deficiency).</IndicationAndUsage>
<Description>Alglucosidase alfa is a hydrolytic lysosomal glycogen-specific enzyme encoded by the predominant of nine observed haplotypes of the human acid α-glucosidase (GAA) gene. Alglucosidase alfa is produced by recombinant DNA technology in a Chinese hamster ovary cell line. Alglucosidase alfa degrades glycogen by catalyzing the hydrolysis of α-1,4- and α-1,6- glycosidic linkages of lysosomal glycogen. Alglucosidase alfa is a glycoprotein with a calculated mass of 99,377 Daltons for the polypeptide chain, and a total mass of approximately 109,000 Daltons, including carbohydrates. Alglucosidase alfa has a specific activity of 3.6 to 5.4 units/mg (one unit is defined as that amount of activity that results in the hydrolysis of 1 micromole of synthetic substrate per minute under specified assay conditions). Alglucosidase alfa is intended for intravenous infusion. It is supplied as a sterile, nonpyrogenic, white to off-white, lyophilized cake or powder for reconstitution with 10.3 mL Sterile Water for Injection, USP. Each 50 mg vial contains 52.5 mg alglucosidase alfa, 210 mg mannitol, 0.5 mg polysorbate 80, 9.9 mg sodium phosphate dibasic heptahydrate, and 31.2 mg sodium phosphate monobasic monohydrate. Following reconstitution as directed, each vial contains 10.5 mL reconstituted solution and a total extractable volume of 10 mL at 5 mg/mL alglucosidase alfa. Alglucosidase alfa does not contain preservatives; each vial is for single dose only.</Description>
</NDC>
<NDC>
<NDCCode>58468-0210-1</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (58468-0210-1) / 5 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>58468-0210-01</NDC11Code>
<ProductNDC>58468-0210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aubagio</ProprietaryName>
<NonProprietaryName>Teriflunomide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202992</ApplicationNumber>
<LabelerName>Genzyme Corporation</LabelerName>
<SubstanceName>TERIFLUNOMIDE</SubstanceName>
<StrengthNumber>14</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AUBAGIO® is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>AUBAGIO (teriflunomide) is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white to almost white powder that is sparingly soluble in acetone, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. AUBAGIO tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: lactose monohydrate, corn starch, hydroxypropyl cellulose, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate. The film coating for the 14 mg tablet is made of hypromellose, titanium dioxide, talc, polyethylene glycol and indigo carmine aluminum lake. In addition to these, the 7 mg tablet film coating includes iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>58468-0210-4</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (58468-0210-4) / 30 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>58468-0210-04</NDC11Code>
<ProductNDC>58468-0210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aubagio</ProprietaryName>
<NonProprietaryName>Teriflunomide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202992</ApplicationNumber>
<LabelerName>Genzyme Corporation</LabelerName>
<SubstanceName>TERIFLUNOMIDE</SubstanceName>
<StrengthNumber>14</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190328</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AUBAGIO® is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>AUBAGIO (teriflunomide) is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white to almost white powder that is sparingly soluble in acetone, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. AUBAGIO tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: lactose monohydrate, corn starch, hydroxypropyl cellulose, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate. The film coating for the 14 mg tablet is made of hypromellose, titanium dioxide, talc, polyethylene glycol and indigo carmine aluminum lake. In addition to these, the 7 mg tablet film coating includes iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>58468-0211-2</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (58468-0211-2) / 5 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>58468-0211-02</NDC11Code>
<ProductNDC>58468-0211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aubagio</ProprietaryName>
<NonProprietaryName>Teriflunomide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202992</ApplicationNumber>
<LabelerName>Genzyme Corporation</LabelerName>
<SubstanceName>TERIFLUNOMIDE</SubstanceName>
<StrengthNumber>7</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AUBAGIO® is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>AUBAGIO (teriflunomide) is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white to almost white powder that is sparingly soluble in acetone, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. AUBAGIO tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: lactose monohydrate, corn starch, hydroxypropyl cellulose, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate. The film coating for the 14 mg tablet is made of hypromellose, titanium dioxide, talc, polyethylene glycol and indigo carmine aluminum lake. In addition to these, the 7 mg tablet film coating includes iron oxide yellow.</Description>
</NDC>
</NDCList>