{
"NDC": [
{
"NDCCode": "10515-146-00",
"PackageDescription": "10 VIAL, GLASS in 1 TRAY (10515-146-00) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS",
"NDC11Code": "10515-0146-00",
"ProductNDC": "10515-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin",
"NonProprietaryName": "Ampicillin Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20080215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA063146",
"LabelerName": "GC Hanford Manufacturing Company",
"SubstanceName": "AMPICILLIN SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20080306",
"SamplePackage": "N"
},
{
"NDCCode": "10515-140-00",
"PackageDescription": "10 VIAL, GLASS in 1 TRAY (10515-140-00) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS",
"NDC11Code": "10515-0140-00",
"ProductNDC": "10515-140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin",
"NonProprietaryName": "Ampicillin Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA063140",
"LabelerName": "GC Hanford Manufacturing Company",
"SubstanceName": "AMPICILLIN SODIUM",
"StrengthNumber": "2",
"StrengthUnit": "g/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20080306",
"SamplePackage": "N"
},
{
"NDCCode": "10515-142-00",
"PackageDescription": "10 VIAL, GLASS in 1 TRAY (10515-142-00) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS",
"NDC11Code": "10515-0142-00",
"ProductNDC": "10515-142",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin",
"NonProprietaryName": "Ampicillin Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20080215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA063142",
"LabelerName": "GC Hanford Manufacturing Company",
"SubstanceName": "AMPICILLIN SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "g/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20080306",
"SamplePackage": "N"
},
{
"NDCCode": "10515-145-00",
"PackageDescription": "10 VIAL, GLASS in 1 TRAY (10515-145-00) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS",
"NDC11Code": "10515-0145-00",
"ProductNDC": "10515-145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin",
"NonProprietaryName": "Ampicillin Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20100917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA063145",
"LabelerName": "GC Hanford Manufacturing Company",
"SubstanceName": "AMPICILLIN SODIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20100917",
"SamplePackage": "N"
},
{
"NDCCode": "10515-772-00",
"PackageDescription": "10 VIAL, GLASS in 1 TRAY (10515-772-00) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS",
"NDC11Code": "10515-0772-00",
"ProductNDC": "10515-772",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin",
"NonProprietaryName": "Ampicillin Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20080215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062772",
"LabelerName": "GC Hanford Manufacturing Company",
"SubstanceName": "AMPICILLIN SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20080306",
"SamplePackage": "N"
},
{
"NDCCode": "24196-146-00",
"PackageDescription": "13 kg in 1 DRUM (24196-146-00)",
"NDC11Code": "24196-0146-00",
"ProductNDC": "24196-146",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ramelteon",
"DosageFormName": "POWDER",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Watson Pharma, Inc.",
"SubstanceName": "RAMELTEON",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "61874-146-00",
"PackageDescription": "1 BAG in 1 DRUM (61874-146-00) / 65000 CAPSULE, GELATIN COATED in 1 BAG",
"NDC11Code": "61874-0146-00",
"ProductNDC": "61874-146",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Cariprazine",
"DosageFormName": "CAPSULE, GELATIN COATED",
"StartMarketingDate": "20150917",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "CARIPRAZINE",
"StrengthNumber": "4.5",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2026-10-09",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "17-SEP-15"
},
{
"NDCCode": "63552-146-00",
"PackageDescription": "52000 CAPSULE in 1 DRUM (63552-146-00)",
"NDC11Code": "63552-0146-00",
"ProductNDC": "63552-146",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Oseltamivir Phosphate",
"DosageFormName": "CAPSULE",
"StartMarketingDate": "19991027",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Patheon Manufacturing Services LLC",
"SubstanceName": "OSELTAMIVIR PHOSPHATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2018-02-02",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "64220-146-00",
"PackageDescription": "3 kg in 1 CANISTER (64220-146-00) ",
"NDC11Code": "64220-0146-00",
"ProductNDC": "64220-146",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ketotifen Fumarate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20240604",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.",
"SubstanceName": "KETOTIFEN FUMARATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-06-05",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "04-JUN-24"
},
{
"NDCCode": "68016-146-00",
"PackageDescription": "236 mL in 1 BOTTLE (68016-146-00)",
"NDC11Code": "68016-0146-00",
"ProductNDC": "68016-146",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Night-time Cherry",
"ProprietaryNameSuffix": "Multi-symptom Cold/flu Relief",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20120901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Chain Drug Consortium, LLC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "650; 30; 12.5",
"StrengthUnit": "mg/30mL; mg/30mL; mg/30mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "temporarily relieves cold/flu symptoms: 1 sore throat, 2 headache , 3 minor aches and pain, 4 fever, 5 runny nose and sneezing, 6 cough due to minor sore throat and bronchial irritation."
},
{
"NDCCode": "72033-146-00",
"PackageDescription": "1 POUCH in 1 CARTON (72033-146-00) / 1 BOTTLE in 1 POUCH / 30 mL in 1 BOTTLE",
"NDC11Code": "72033-0146-00",
"ProductNDC": "72033-146",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Disney Touchland Power Mist Hydrating Hand Sanitizer, Wild Watermelon",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250430",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "TOUCHLAND LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "76144-146-00",
"PackageDescription": "60 mL in 1 TUBE (76144-146-00) ",
"NDC11Code": "76144-0146-00",
"ProductNDC": "76144-146",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Paulas Choice Skin Recovery Daily Moisturizing Spf 30",
"NonProprietaryName": "Titanium Dioxide, Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110627",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Paula's Choice LLC",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "38.5; 31.2",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2023-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20110627",
"SamplePackage": "N"
},
{
"NDCCode": "76339-146-00",
"PackageDescription": "1 BAG in 1 DRUM (76339-146-00) > 1 BAG in 1 BAG > .999 kg in 1 BAG",
"NDC11Code": "76339-0146-00",
"ProductNDC": "76339-146",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sevelamer Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20190911",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Apothecon Pharmaceuticals Pvt Ltd",
"SubstanceName": "SEVELAMER HYDROCHLORIDE",
"StrengthNumber": ".999",
"StrengthUnit": "kg/.999kg",
"Status": "Unfinished",
"LastUpdate": "2022-11-15",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "11-SEP-19"
},
{
"NDCCode": "80684-146-00",
"PackageDescription": "28 g in 1 TUBE (80684-146-00) ",
"NDC11Code": "80684-0146-00",
"ProductNDC": "80684-146",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Thera Plus Eczema Hydrocortisone Anti Itch",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250303",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Fourstar Group USA, Inc.",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250303",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves itching associated with minor skin irritations,inflammation and rashes due to: . eczema . psoriasis . poison ivy,oak,sumac. insect bites . detergents . jewelry . cosmetics . soaps . seborrheic dermatitis. temporarily relieves external anal and genital itching. other uses of this product should be under advice and supervision of a doctor."
},
{
"NDCCode": "82691-146-00",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (82691-146-00) / 50 mL in 1 BOTTLE, PUMP",
"NDC11Code": "82691-0146-00",
"ProductNDC": "82691-146",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Soleil Superieur Broad Spectrum Spf 50 Sunscreen Us",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "RV Skincare LLC",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 100; 50; 26",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20171201",
"SamplePackage": "N",
"IndicationAndUsage": " helps prevent sunburn. if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions."
},
{
"NDCCode": "0024-5901-00",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (0024-5901-00) / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00024-5901-00",
"ProductNDC": "0024-5901",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Praluent",
"NonProprietaryName": "Alirocumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150724",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125559",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "ALIROCUMAB",
"StrengthNumber": "75",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150724",
"SamplePackage": "N",
"IndicationAndUsage": "PRALUENT® is indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (coronary heart disease death, myocardial infarction, stroke, or unstable angina requiring hospitalization) in adults at increased risk for these events., 2 As an adjunct to diet and exercise to reduce low- density lipoprotein cholesterol (LDL-C) in:adults with hypercholesterolemia.adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).adults with homozygous familial hypercholesterolemia (HoFH).",
"Description": "Alirocumab is a human monoclonal antibody (IgG1 isotype) that targets proprotein convertase subtilisin kexin type 9 (PCSK9). Alirocumab is a PCSK9 inhibitor produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. Alirocumab consists of two disulfide-linked human heavy chains, each covalently linked through a disulfide bond to a human kappa light chain. A single N-linked glycosylation site is located in each heavy chain within the CH2 domain of the Fc constant region of the molecule. The variable domains of the heavy and light chains combine to form the PCSK9 binding site within the antibody. Alirocumab has an approximate molecular weight of 146 kDa. PRALUENT is a sterile, preservative-free, clear, colorless to pale yellow solution for subcutaneous use. PRALUENT 75 mg/mL or 150 mg/mL solution for subcutaneous injection in a single-dose pre-filled pen is supplied in a siliconized 1 mL Type-1 clear glass syringe. Each 75 mg/mL pre-filled pen contains 75 mg alirocumab, histidine (8 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0. Each 150 mg/mL pre-filled pen contains 150 mg alirocumab, histidine (6 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0."
},
{
"NDCCode": "0024-5902-00",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (0024-5902-00) / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00024-5902-00",
"ProductNDC": "0024-5902",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Praluent",
"NonProprietaryName": "Alirocumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150724",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125559",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "ALIROCUMAB",
"StrengthNumber": "150",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150724",
"SamplePackage": "N",
"IndicationAndUsage": "PRALUENT® is indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (coronary heart disease death, myocardial infarction, stroke, or unstable angina requiring hospitalization) in adults at increased risk for these events., 2 As an adjunct to diet and exercise to reduce low- density lipoprotein cholesterol (LDL-C) in:adults with hypercholesterolemia.adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).adults with homozygous familial hypercholesterolemia (HoFH).",
"Description": "Alirocumab is a human monoclonal antibody (IgG1 isotype) that targets proprotein convertase subtilisin kexin type 9 (PCSK9). Alirocumab is a PCSK9 inhibitor produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. Alirocumab consists of two disulfide-linked human heavy chains, each covalently linked through a disulfide bond to a human kappa light chain. A single N-linked glycosylation site is located in each heavy chain within the CH2 domain of the Fc constant region of the molecule. The variable domains of the heavy and light chains combine to form the PCSK9 binding site within the antibody. Alirocumab has an approximate molecular weight of 146 kDa. PRALUENT is a sterile, preservative-free, clear, colorless to pale yellow solution for subcutaneous use. PRALUENT 75 mg/mL or 150 mg/mL solution for subcutaneous injection in a single-dose pre-filled pen is supplied in a siliconized 1 mL Type-1 clear glass syringe. Each 75 mg/mL pre-filled pen contains 75 mg alirocumab, histidine (8 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0. Each 150 mg/mL pre-filled pen contains 150 mg alirocumab, histidine (6 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0."
},
{
"NDCCode": "49281-575-00",
"PackageDescription": "1 SYRINGE in 1 CARTON (49281-575-00) / .5 mL in 1 SYRINGE",
"NDC11Code": "49281-0575-00",
"ProductNDC": "49281-575",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Beyfortus",
"NonProprietaryName": "Nirsevimab",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20230718",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761328",
"LabelerName": "Sanofi Vaccines US Inc.",
"SubstanceName": "NIRSEVIMAB",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Fusion Protein Inhibitors [MoA], Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230718",
"SamplePackage": "N",
"IndicationAndUsage": "BEYFORTUS is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in: 1 Neonates and infants born during or entering their first RSV season., 2 Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.",
"Description": "Nirsevimab-alip, a respiratory syncytial virus F protein-directed fusion inhibitor, is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. The molecular weight is approximately 146.3 kDa. BEYFORTUS (nirsevimab-alip) injection is a sterile, preservative-free, clear to opalescent, colorless to yellow solution for intramuscular injection. It is supplied in a single-dose siliconized Luer lock Type I glass pre-filled syringe with a FluroTec coated plunger stopper. Each 0.5 mL contains 50 mg nirsevimab-alip, arginine hydrochloride (8 mg), histidine (1.1 mg), L-histidine hydrochloride monohydrate (1.6 mg), polysorbate 80 (0.1 mg), sucrose (21 mg), and water for injection (USP). The pH is 6.0. Each 1 mL contains 100 mg nirsevimab-alip, arginine hydrochloride (17 mg), histidine (2.2 mg), L-histidine hydrochloride monohydrate (3.3 mg), polysorbate 80 (0.2 mg), sucrose (41 mg), and water for injection (USP). The pH is 6.0."
},
{
"NDCCode": "61755-012-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (61755-012-01) / 5 mL in 1 VIAL, SINGLE-DOSE (61755-012-00) ",
"NDC11Code": "61755-0012-01",
"ProductNDC": "61755-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pasatru",
"NonProprietaryName": "Garetosmab-grts",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260819",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761508",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
"SubstanceName": "GARETOSMAB",
"StrengthNumber": "300",
"StrengthUnit": "mg/5mL",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260819",
"SamplePackage": "N",
"IndicationAndUsage": "PASATRU is indicated to reduce formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP).",
"Description": "Garetosmab-grts is an activin signaling inhibitor. Garetosmab-grts is a human IgG4 monoclonal antibody produced by recombinant DNA technology in Chinese hamster ovary cell suspension culture. Garetosmab-grts has an approximate molecular weight of 146 kDa. PASATRU (garetosmab-grts) injection is a sterile, preservative-free solution for intravenous use. The solution is clear to slightly opalescent, colorless to pale yellow with a pH of 6.3. Each PASATRU 300 mg/5 mL vial contains 300 mg of garetosmab-grts. Each mL contains 60 mg of garetosmab-grts, arginine hydrochloride (14.7 mg), histidine (1 mg), L-histidine hydrochloride monohydrate (0.7 mg), polysorbate 20 (0.5 mg), sucrose (50 mg), and Water for Injection, USP."
},
{
"NDCCode": "61755-018-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (61755-018-01) / 14.5 mL in 1 VIAL, SINGLE-DOSE (61755-018-00) ",
"NDC11Code": "61755-0018-01",
"ProductNDC": "61755-018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Inmazeb",
"NonProprietaryName": "Atoltivimab, Maftivimab, And Odesivimab-ebgn",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201014",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761169",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
"SubstanceName": "ATOLTIVIMAB; MAFTIVIMAB; ODESIVIMAB",
"StrengthNumber": "241.7; 241.7; 241.7",
"StrengthUnit": "mg/14.5mL; mg/14.5mL; mg/14.5mL",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201014",
"SamplePackage": "N",
"IndicationAndUsage": "INMAZEB is indicated for the treatment of infection caused by Orthoebolavirus zairense in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection [see Dosage and Administration (2.2), and Clinical Studies (14)].",
"Description": "Atoltivimab, maftivimab, and odesivimab-ebgn is a combination of Orthoebolavirus zairense glycoprotein (GP) directed recombinant human IgG1 human monoclonal antibodies of similar structure. The human monoclonal antibodies, atoltivimab, maftivimab, and odesivimab are produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and have an approximate molecular weight of 145 kDa, 146 kDa and 144 kDa, respectively. INMAZEB (atoltivimab, maftivimab, and odesivimab-ebgn) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution, that is free from visible particulates. INMAZEB injection is supplied as two strength presentations: 1 16.67 mg/16.67 mg/16.67 mg per mL: Each vial contains 241.7 mg of atoltivimab, 241.7 mg of maftivimab, and 241.7 mg of odesivimab in 14.5 mL. Each mL contains 16.67 mg of atoltivimab, 16.67 mg of maftivimab, 16.67 mg of odesivimab, and L-histidine (0.74 mg), L-histidine monohydrochloride monohydrate (1.09 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP with a pH of 6.0., 2 33.33 mg/33.33 mg/33.33 mg per mL: Each vial contains 483.3 mg of atoltivimab, 483.3 mg of maftivimab, and 483.3 mg of odesivimab in 14.5 mL. Each mL contains 33.33 mg of atoltivimab, 33.33 mg of maftivimab, 33.33 mg of odesivimab, and L-histidine (0.74 mg), L-histidine monohydrochloride monohydrate (1.09 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP with a pH of 6.0."
},
{
"NDCCode": "61755-019-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (61755-019-01) / 14.5 mL in 1 VIAL, SINGLE-DOSE (61755-019-00) ",
"NDC11Code": "61755-0019-01",
"ProductNDC": "61755-019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Inmazeb",
"NonProprietaryName": "Atoltivimab, Maftivimab, And Odesivimab-ebgn",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210729",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761169",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
"SubstanceName": "ATOLTIVIMAB; MAFTIVIMAB; ODESIVIMAB",
"StrengthNumber": "483.3; 483.3; 483.3",
"StrengthUnit": "mg/14.5mL; mg/14.5mL; mg/14.5mL",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210729",
"SamplePackage": "N",
"IndicationAndUsage": "INMAZEB is indicated for the treatment of infection caused by Orthoebolavirus zairense in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection [see Dosage and Administration (2.2), and Clinical Studies (14)].",
"Description": "Atoltivimab, maftivimab, and odesivimab-ebgn is a combination of Orthoebolavirus zairense glycoprotein (GP) directed recombinant human IgG1 human monoclonal antibodies of similar structure. The human monoclonal antibodies, atoltivimab, maftivimab, and odesivimab are produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and have an approximate molecular weight of 145 kDa, 146 kDa and 144 kDa, respectively. INMAZEB (atoltivimab, maftivimab, and odesivimab-ebgn) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution, that is free from visible particulates. INMAZEB injection is supplied as two strength presentations: 1 16.67 mg/16.67 mg/16.67 mg per mL: Each vial contains 241.7 mg of atoltivimab, 241.7 mg of maftivimab, and 241.7 mg of odesivimab in 14.5 mL. Each mL contains 16.67 mg of atoltivimab, 16.67 mg of maftivimab, 16.67 mg of odesivimab, and L-histidine (0.74 mg), L-histidine monohydrochloride monohydrate (1.09 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP with a pH of 6.0., 2 33.33 mg/33.33 mg/33.33 mg per mL: Each vial contains 483.3 mg of atoltivimab, 483.3 mg of maftivimab, and 483.3 mg of odesivimab in 14.5 mL. Each mL contains 33.33 mg of atoltivimab, 33.33 mg of maftivimab, 33.33 mg of odesivimab, and L-histidine (0.74 mg), L-histidine monohydrochloride monohydrate (1.09 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP with a pH of 6.0."
},
{
"NDCCode": "61755-054-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (61755-054-01) / 2.5 mL in 1 VIAL, SINGLE-DOSE (61755-054-00) ",
"NDC11Code": "61755-0054-01",
"ProductNDC": "61755-054",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lynozyfic",
"NonProprietaryName": "Linvoseltamab-gcpt",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250702",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761400",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
"SubstanceName": "LINVOSELTAMAB",
"StrengthNumber": "5",
"StrengthUnit": "mg/2.5mL",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250702",
"SamplePackage": "N",
"IndicationAndUsage": "LYNOZYFIC is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).",
"Description": "Linvoseltamab-gcpt, a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, is a recombinant human immunoglobulin (Ig)G4 antibody. Linvoseltamab-gcpt is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture. The molecular weight of linvoseltamab-gcpt is approximately 146 kDa. LYNOZYFIC (linvoseltamab-gcpt) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution with a pH 6.0. Each LYNOZYFIC 5 mg/2.5 mL vial contains 5 mg of linvoseltamab-gcpt. Each mL contains 2 mg of linvoseltamab-gcpt, histidine (0.7 mg), L-histidine hydrochloride monohydrate (1.1 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP. Each LYNOZYFIC 200 mg/10 mL vial contains 200 mg of linvoseltamab-gcpt. Each mL contains 20 mg of linvoseltamab-gcpt, histidine (0.7 mg), L-histidine hydrochloride monohydrate (1.1 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP."
},
{
"NDCCode": "61755-056-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (61755-056-01) / 10 mL in 1 VIAL, SINGLE-DOSE (61755-056-00) ",
"NDC11Code": "61755-0056-01",
"ProductNDC": "61755-056",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lynozyfic",
"NonProprietaryName": "Linvoseltamab-gcpt",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250702",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761400",
"LabelerName": "Regeneron Pharmaceuticals, Inc.",
"SubstanceName": "LINVOSELTAMAB",
"StrengthNumber": "200",
"StrengthUnit": "mg/10mL",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250702",
"SamplePackage": "N",
"IndicationAndUsage": "LYNOZYFIC is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).",
"Description": "Linvoseltamab-gcpt, a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, is a recombinant human immunoglobulin (Ig)G4 antibody. Linvoseltamab-gcpt is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture. The molecular weight of linvoseltamab-gcpt is approximately 146 kDa. LYNOZYFIC (linvoseltamab-gcpt) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution with a pH 6.0. Each LYNOZYFIC 5 mg/2.5 mL vial contains 5 mg of linvoseltamab-gcpt. Each mL contains 2 mg of linvoseltamab-gcpt, histidine (0.7 mg), L-histidine hydrochloride monohydrate (1.1 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP. Each LYNOZYFIC 200 mg/10 mL vial contains 200 mg of linvoseltamab-gcpt. Each mL contains 20 mg of linvoseltamab-gcpt, histidine (0.7 mg), L-histidine hydrochloride monohydrate (1.1 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP."
},
{
"NDCCode": "73555-500-00",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (73555-500-00) ",
"NDC11Code": "73555-0500-00",
"ProductNDC": "73555-500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Revuforj",
"NonProprietaryName": "Revumenib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20241115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218944",
"LabelerName": "Syndax Pharmaceuticals, Inc.",
"SubstanceName": "REVUMENIB CITRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Menin Inhibitor [EPC], Menin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241115",
"SamplePackage": "N",
"IndicationAndUsage": "REVUFORJ is a menin inhibitor indicated for. : 1 the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation as determined by an FDA-authorized test in adult and pediatric patients 1 year and older. (1), 2 the treatment of relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options. (1).",
"Description": "REVUFORJ contains revumenib, a menin inhibitor. Revumenib is present as revumenib citrate hydrate with a chemical name of benzamide, N-ethyl-2-[[4-[7-[[trans-4- [(ethylsulfonyl)amino]cyclohexyl]methyl]-2,7-diazaspiro[3.5]non-2-yl]-5-pyrimidinyl]oxy]-5-fluoro-N-[1- methylethyl]-, 2-hydroxypropane-1,2,3-tricarboxylic acid, hydrate (1:1:1). The molecular formula is C32H47FN6O4S●C6H8O7●H2O with a molecular weight 840.96 g/mol. Revumenib citrate hydrate is a white to faint pink solid. Revumenib citrate hydrate is soluble at pH 1.2 and 6.8, and sparingly soluble at pH 4.5. The chemical structure is shown in Figure 1. Figure 1: Chemical structure of Revumenib Citrate. REVUFORJ is available as tablets for oral use. Each 25 mg strength tablet contains 25 mg revumenib, equivalent to 33.4 mg revumenib citrate, and the following inactive ingredients: microcrystalline cellulose, dicalcium phosphate, crospovidone, hypromellose, sodium bicarbonate, hydrophobic colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and red iron oxide. Each 110 mg strength tablet contains 110 mg revumenib, equivalent to 146.5 mg revumenib citrate, and the following inactive ingredients: microcrystalline cellulose, dicalcium phosphate, crospovidone, hypromellose, sodium bicarbonate, hydrophobic colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, red iron oxide, and yellow iron oxide. Each 160 mg strength tablet contains 160 mg revumenib equivalent to 213.2 mg revumenib citrate, and the following inactive ingredients: microcrystalline cellulose, dicalcium phosphate, crospovidone, hypromellose, sodium bicarbonate, hydrophobic colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, red iron oxide, and FD&C blue #2/indigo carmine aluminum lake."
},
{
"NDCCode": "73555-501-00",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (73555-501-00) ",
"NDC11Code": "73555-0501-00",
"ProductNDC": "73555-501",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Revuforj",
"NonProprietaryName": "Revumenib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20241115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218944",
"LabelerName": "Syndax Pharmaceuticals, Inc.",
"SubstanceName": "REVUMENIB CITRATE",
"StrengthNumber": "110",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Menin Inhibitor [EPC], Menin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241115",
"SamplePackage": "N",
"IndicationAndUsage": "REVUFORJ is a menin inhibitor indicated for. : 1 the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation as determined by an FDA-authorized test in adult and pediatric patients 1 year and older. (1), 2 the treatment of relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options. (1).",
"Description": "REVUFORJ contains revumenib, a menin inhibitor. Revumenib is present as revumenib citrate hydrate with a chemical name of benzamide, N-ethyl-2-[[4-[7-[[trans-4- [(ethylsulfonyl)amino]cyclohexyl]methyl]-2,7-diazaspiro[3.5]non-2-yl]-5-pyrimidinyl]oxy]-5-fluoro-N-[1- methylethyl]-, 2-hydroxypropane-1,2,3-tricarboxylic acid, hydrate (1:1:1). The molecular formula is C32H47FN6O4S●C6H8O7●H2O with a molecular weight 840.96 g/mol. Revumenib citrate hydrate is a white to faint pink solid. Revumenib citrate hydrate is soluble at pH 1.2 and 6.8, and sparingly soluble at pH 4.5. The chemical structure is shown in Figure 1. Figure 1: Chemical structure of Revumenib Citrate. REVUFORJ is available as tablets for oral use. Each 25 mg strength tablet contains 25 mg revumenib, equivalent to 33.4 mg revumenib citrate, and the following inactive ingredients: microcrystalline cellulose, dicalcium phosphate, crospovidone, hypromellose, sodium bicarbonate, hydrophobic colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and red iron oxide. Each 110 mg strength tablet contains 110 mg revumenib, equivalent to 146.5 mg revumenib citrate, and the following inactive ingredients: microcrystalline cellulose, dicalcium phosphate, crospovidone, hypromellose, sodium bicarbonate, hydrophobic colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, red iron oxide, and yellow iron oxide. Each 160 mg strength tablet contains 160 mg revumenib equivalent to 213.2 mg revumenib citrate, and the following inactive ingredients: microcrystalline cellulose, dicalcium phosphate, crospovidone, hypromellose, sodium bicarbonate, hydrophobic colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, red iron oxide, and FD&C blue #2/indigo carmine aluminum lake."
},
{
"NDCCode": "73555-502-00",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (73555-502-00) ",
"NDC11Code": "73555-0502-00",
"ProductNDC": "73555-502",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Revuforj",
"NonProprietaryName": "Revumenib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20241115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218944",
"LabelerName": "Syndax Pharmaceuticals, Inc.",
"SubstanceName": "REVUMENIB CITRATE",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Menin Inhibitor [EPC], Menin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241115",
"SamplePackage": "N",
"IndicationAndUsage": "REVUFORJ is a menin inhibitor indicated for. : 1 the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation as determined by an FDA-authorized test in adult and pediatric patients 1 year and older. (1), 2 the treatment of relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options. (1).",
"Description": "REVUFORJ contains revumenib, a menin inhibitor. Revumenib is present as revumenib citrate hydrate with a chemical name of benzamide, N-ethyl-2-[[4-[7-[[trans-4- [(ethylsulfonyl)amino]cyclohexyl]methyl]-2,7-diazaspiro[3.5]non-2-yl]-5-pyrimidinyl]oxy]-5-fluoro-N-[1- methylethyl]-, 2-hydroxypropane-1,2,3-tricarboxylic acid, hydrate (1:1:1). The molecular formula is C32H47FN6O4S●C6H8O7●H2O with a molecular weight 840.96 g/mol. Revumenib citrate hydrate is a white to faint pink solid. Revumenib citrate hydrate is soluble at pH 1.2 and 6.8, and sparingly soluble at pH 4.5. The chemical structure is shown in Figure 1. Figure 1: Chemical structure of Revumenib Citrate. REVUFORJ is available as tablets for oral use. Each 25 mg strength tablet contains 25 mg revumenib, equivalent to 33.4 mg revumenib citrate, and the following inactive ingredients: microcrystalline cellulose, dicalcium phosphate, crospovidone, hypromellose, sodium bicarbonate, hydrophobic colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and red iron oxide. Each 110 mg strength tablet contains 110 mg revumenib, equivalent to 146.5 mg revumenib citrate, and the following inactive ingredients: microcrystalline cellulose, dicalcium phosphate, crospovidone, hypromellose, sodium bicarbonate, hydrophobic colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, red iron oxide, and yellow iron oxide. Each 160 mg strength tablet contains 160 mg revumenib equivalent to 213.2 mg revumenib citrate, and the following inactive ingredients: microcrystalline cellulose, dicalcium phosphate, crospovidone, hypromellose, sodium bicarbonate, hydrophobic colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, red iron oxide, and FD&C blue #2/indigo carmine aluminum lake."
},
{
"NDCCode": "85766-059-00",
"PackageDescription": "1000 mL in 1 BAG (85766-059-00) ",
"NDC11Code": "85766-0059-00",
"ProductNDC": "85766-059",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Chloride",
"NonProprietaryName": "Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19701209",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016677",
"LabelerName": "Sportpharm LLC",
"SubstanceName": "SODIUM CHLORIDE",
"StrengthNumber": "9",
"StrengthUnit": "g/1000mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250822",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. 0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodialysis procedures.",
"Description": "Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The nominal pH is 5.0 (4.5 to 7.0). Composition, osmolarity, and ionic concentration are shown below. 0.9% Sodium Chloride Injection, USPcontains 9 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2- ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "0002-1445-09",
"PackageDescription": "3 SYRINGE in 1 CARTON (0002-1445-09) / 1 mL in 1 SYRINGE (0002-1445-01) ",
"NDC11Code": "00002-1445-09",
"ProductNDC": "0002-1445",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Taltz",
"NonProprietaryName": "Ixekizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20160322",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125521",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "IXEKIZUMAB",
"StrengthNumber": "80",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160322",
"SamplePackage": "N",
"IndicationAndUsage": "TALTZ® is a humanized interleukin-17A antagonist indicated for the treatment of: : 1 patients aged 6 years or older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. (1.1) , 2 adults with active psoriatic arthritis. (1.2) , 3 adults with active ankylosing spondylitis. (1.3) , 4 adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation. (1.4) .",
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}
]
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<NonProprietaryName>Sevelamer Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20190911</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Apothecon Pharmaceuticals Pvt Ltd</LabelerName>
<SubstanceName>SEVELAMER HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.999</StrengthNumber>
<StrengthUnit>kg/.999kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-11-15</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>11-SEP-19</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>80684-146-00</NDCCode>
<PackageDescription>28 g in 1 TUBE (80684-146-00) </PackageDescription>
<NDC11Code>80684-0146-00</NDC11Code>
<ProductNDC>80684-146</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Thera Plus Eczema Hydrocortisone Anti Itch</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250303</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Fourstar Group USA, Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves itching associated with minor skin irritations,inflammation and rashes due to: . eczema . psoriasis . poison ivy,oak,sumac. insect bites . detergents . jewelry . cosmetics . soaps . seborrheic dermatitis. temporarily relieves external anal and genital itching. other uses of this product should be under advice and supervision of a doctor.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82691-146-00</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (82691-146-00) / 50 mL in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>82691-0146-00</NDC11Code>
<ProductNDC>82691-146</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Soleil Superieur Broad Spectrum Spf 50 Sunscreen Us</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>RV Skincare LLC</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 100; 50; 26</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> helps prevent sunburn. if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0024-5901-00</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (0024-5901-00) / 1 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>00024-5901-00</NDC11Code>
<ProductNDC>0024-5901</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Praluent</ProprietaryName>
<NonProprietaryName>Alirocumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150724</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125559</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>ALIROCUMAB</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PRALUENT® is indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (coronary heart disease death, myocardial infarction, stroke, or unstable angina requiring hospitalization) in adults at increased risk for these events., 2 As an adjunct to diet and exercise to reduce low- density lipoprotein cholesterol (LDL-C) in:adults with hypercholesterolemia.adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).adults with homozygous familial hypercholesterolemia (HoFH).</IndicationAndUsage>
<Description>Alirocumab is a human monoclonal antibody (IgG1 isotype) that targets proprotein convertase subtilisin kexin type 9 (PCSK9). Alirocumab is a PCSK9 inhibitor produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. Alirocumab consists of two disulfide-linked human heavy chains, each covalently linked through a disulfide bond to a human kappa light chain. A single N-linked glycosylation site is located in each heavy chain within the CH2 domain of the Fc constant region of the molecule. The variable domains of the heavy and light chains combine to form the PCSK9 binding site within the antibody. Alirocumab has an approximate molecular weight of 146 kDa. PRALUENT is a sterile, preservative-free, clear, colorless to pale yellow solution for subcutaneous use. PRALUENT 75 mg/mL or 150 mg/mL solution for subcutaneous injection in a single-dose pre-filled pen is supplied in a siliconized 1 mL Type-1 clear glass syringe. Each 75 mg/mL pre-filled pen contains 75 mg alirocumab, histidine (8 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0. Each 150 mg/mL pre-filled pen contains 150 mg alirocumab, histidine (6 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0.</Description>
</NDC>
<NDC>
<NDCCode>0024-5902-00</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (0024-5902-00) / 1 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>00024-5902-00</NDC11Code>
<ProductNDC>0024-5902</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Praluent</ProprietaryName>
<NonProprietaryName>Alirocumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150724</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125559</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>ALIROCUMAB</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PRALUENT® is indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (coronary heart disease death, myocardial infarction, stroke, or unstable angina requiring hospitalization) in adults at increased risk for these events., 2 As an adjunct to diet and exercise to reduce low- density lipoprotein cholesterol (LDL-C) in:adults with hypercholesterolemia.adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).adults with homozygous familial hypercholesterolemia (HoFH).</IndicationAndUsage>
<Description>Alirocumab is a human monoclonal antibody (IgG1 isotype) that targets proprotein convertase subtilisin kexin type 9 (PCSK9). Alirocumab is a PCSK9 inhibitor produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. Alirocumab consists of two disulfide-linked human heavy chains, each covalently linked through a disulfide bond to a human kappa light chain. A single N-linked glycosylation site is located in each heavy chain within the CH2 domain of the Fc constant region of the molecule. The variable domains of the heavy and light chains combine to form the PCSK9 binding site within the antibody. Alirocumab has an approximate molecular weight of 146 kDa. PRALUENT is a sterile, preservative-free, clear, colorless to pale yellow solution for subcutaneous use. PRALUENT 75 mg/mL or 150 mg/mL solution for subcutaneous injection in a single-dose pre-filled pen is supplied in a siliconized 1 mL Type-1 clear glass syringe. Each 75 mg/mL pre-filled pen contains 75 mg alirocumab, histidine (8 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0. Each 150 mg/mL pre-filled pen contains 150 mg alirocumab, histidine (6 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0.</Description>
</NDC>
<NDC>
<NDCCode>49281-575-00</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (49281-575-00) / .5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>49281-0575-00</NDC11Code>
<ProductNDC>49281-575</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Beyfortus</ProprietaryName>
<NonProprietaryName>Nirsevimab</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20230718</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761328</ApplicationNumber>
<LabelerName>Sanofi Vaccines US Inc.</LabelerName>
<SubstanceName>NIRSEVIMAB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Fusion Protein Inhibitors [MoA], Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BEYFORTUS is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in: 1 Neonates and infants born during or entering their first RSV season., 2 Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.</IndicationAndUsage>
<Description>Nirsevimab-alip, a respiratory syncytial virus F protein-directed fusion inhibitor, is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. The molecular weight is approximately 146.3 kDa. BEYFORTUS (nirsevimab-alip) injection is a sterile, preservative-free, clear to opalescent, colorless to yellow solution for intramuscular injection. It is supplied in a single-dose siliconized Luer lock Type I glass pre-filled syringe with a FluroTec coated plunger stopper. Each 0.5 mL contains 50 mg nirsevimab-alip, arginine hydrochloride (8 mg), histidine (1.1 mg), L-histidine hydrochloride monohydrate (1.6 mg), polysorbate 80 (0.1 mg), sucrose (21 mg), and water for injection (USP). The pH is 6.0. Each 1 mL contains 100 mg nirsevimab-alip, arginine hydrochloride (17 mg), histidine (2.2 mg), L-histidine hydrochloride monohydrate (3.3 mg), polysorbate 80 (0.2 mg), sucrose (41 mg), and water for injection (USP). The pH is 6.0.</Description>
</NDC>
<NDC>
<NDCCode>61755-012-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (61755-012-01) / 5 mL in 1 VIAL, SINGLE-DOSE (61755-012-00) </PackageDescription>
<NDC11Code>61755-0012-01</NDC11Code>
<ProductNDC>61755-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pasatru</ProprietaryName>
<NonProprietaryName>Garetosmab-grts</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260819</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761508</ApplicationNumber>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GARETOSMAB</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260819</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PASATRU is indicated to reduce formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP).</IndicationAndUsage>
<Description>Garetosmab-grts is an activin signaling inhibitor. Garetosmab-grts is a human IgG4 monoclonal antibody produced by recombinant DNA technology in Chinese hamster ovary cell suspension culture. Garetosmab-grts has an approximate molecular weight of 146 kDa. PASATRU (garetosmab-grts) injection is a sterile, preservative-free solution for intravenous use. The solution is clear to slightly opalescent, colorless to pale yellow with a pH of 6.3. Each PASATRU 300 mg/5 mL vial contains 300 mg of garetosmab-grts. Each mL contains 60 mg of garetosmab-grts, arginine hydrochloride (14.7 mg), histidine (1 mg), L-histidine hydrochloride monohydrate (0.7 mg), polysorbate 20 (0.5 mg), sucrose (50 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>61755-018-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (61755-018-01) / 14.5 mL in 1 VIAL, SINGLE-DOSE (61755-018-00) </PackageDescription>
<NDC11Code>61755-0018-01</NDC11Code>
<ProductNDC>61755-018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Inmazeb</ProprietaryName>
<NonProprietaryName>Atoltivimab, Maftivimab, And Odesivimab-ebgn</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20201014</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761169</ApplicationNumber>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ATOLTIVIMAB; MAFTIVIMAB; ODESIVIMAB</SubstanceName>
<StrengthNumber>241.7; 241.7; 241.7</StrengthNumber>
<StrengthUnit>mg/14.5mL; mg/14.5mL; mg/14.5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INMAZEB is indicated for the treatment of infection caused by Orthoebolavirus zairense in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection [see Dosage and Administration (2.2), and Clinical Studies (14)].</IndicationAndUsage>
<Description>Atoltivimab, maftivimab, and odesivimab-ebgn is a combination of Orthoebolavirus zairense glycoprotein (GP) directed recombinant human IgG1 human monoclonal antibodies of similar structure. The human monoclonal antibodies, atoltivimab, maftivimab, and odesivimab are produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and have an approximate molecular weight of 145 kDa, 146 kDa and 144 kDa, respectively. INMAZEB (atoltivimab, maftivimab, and odesivimab-ebgn) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution, that is free from visible particulates. INMAZEB injection is supplied as two strength presentations: 1 16.67 mg/16.67 mg/16.67 mg per mL: Each vial contains 241.7 mg of atoltivimab, 241.7 mg of maftivimab, and 241.7 mg of odesivimab in 14.5 mL. Each mL contains 16.67 mg of atoltivimab, 16.67 mg of maftivimab, 16.67 mg of odesivimab, and L-histidine (0.74 mg), L-histidine monohydrochloride monohydrate (1.09 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP with a pH of 6.0., 2 33.33 mg/33.33 mg/33.33 mg per mL: Each vial contains 483.3 mg of atoltivimab, 483.3 mg of maftivimab, and 483.3 mg of odesivimab in 14.5 mL. Each mL contains 33.33 mg of atoltivimab, 33.33 mg of maftivimab, 33.33 mg of odesivimab, and L-histidine (0.74 mg), L-histidine monohydrochloride monohydrate (1.09 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP with a pH of 6.0.</Description>
</NDC>
<NDC>
<NDCCode>61755-019-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (61755-019-01) / 14.5 mL in 1 VIAL, SINGLE-DOSE (61755-019-00) </PackageDescription>
<NDC11Code>61755-0019-01</NDC11Code>
<ProductNDC>61755-019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Inmazeb</ProprietaryName>
<NonProprietaryName>Atoltivimab, Maftivimab, And Odesivimab-ebgn</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210729</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761169</ApplicationNumber>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ATOLTIVIMAB; MAFTIVIMAB; ODESIVIMAB</SubstanceName>
<StrengthNumber>483.3; 483.3; 483.3</StrengthNumber>
<StrengthUnit>mg/14.5mL; mg/14.5mL; mg/14.5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INMAZEB is indicated for the treatment of infection caused by Orthoebolavirus zairense in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection [see Dosage and Administration (2.2), and Clinical Studies (14)].</IndicationAndUsage>
<Description>Atoltivimab, maftivimab, and odesivimab-ebgn is a combination of Orthoebolavirus zairense glycoprotein (GP) directed recombinant human IgG1 human monoclonal antibodies of similar structure. The human monoclonal antibodies, atoltivimab, maftivimab, and odesivimab are produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and have an approximate molecular weight of 145 kDa, 146 kDa and 144 kDa, respectively. INMAZEB (atoltivimab, maftivimab, and odesivimab-ebgn) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution, that is free from visible particulates. INMAZEB injection is supplied as two strength presentations: 1 16.67 mg/16.67 mg/16.67 mg per mL: Each vial contains 241.7 mg of atoltivimab, 241.7 mg of maftivimab, and 241.7 mg of odesivimab in 14.5 mL. Each mL contains 16.67 mg of atoltivimab, 16.67 mg of maftivimab, 16.67 mg of odesivimab, and L-histidine (0.74 mg), L-histidine monohydrochloride monohydrate (1.09 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP with a pH of 6.0., 2 33.33 mg/33.33 mg/33.33 mg per mL: Each vial contains 483.3 mg of atoltivimab, 483.3 mg of maftivimab, and 483.3 mg of odesivimab in 14.5 mL. Each mL contains 33.33 mg of atoltivimab, 33.33 mg of maftivimab, 33.33 mg of odesivimab, and L-histidine (0.74 mg), L-histidine monohydrochloride monohydrate (1.09 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP with a pH of 6.0.</Description>
</NDC>
<NDC>
<NDCCode>61755-054-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (61755-054-01) / 2.5 mL in 1 VIAL, SINGLE-DOSE (61755-054-00) </PackageDescription>
<NDC11Code>61755-0054-01</NDC11Code>
<ProductNDC>61755-054</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lynozyfic</ProprietaryName>
<NonProprietaryName>Linvoseltamab-gcpt</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250702</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761400</ApplicationNumber>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LINVOSELTAMAB</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/2.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250702</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LYNOZYFIC is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).</IndicationAndUsage>
<Description>Linvoseltamab-gcpt, a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, is a recombinant human immunoglobulin (Ig)G4 antibody. Linvoseltamab-gcpt is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture. The molecular weight of linvoseltamab-gcpt is approximately 146 kDa. LYNOZYFIC (linvoseltamab-gcpt) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution with a pH 6.0. Each LYNOZYFIC 5 mg/2.5 mL vial contains 5 mg of linvoseltamab-gcpt. Each mL contains 2 mg of linvoseltamab-gcpt, histidine (0.7 mg), L-histidine hydrochloride monohydrate (1.1 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP. Each LYNOZYFIC 200 mg/10 mL vial contains 200 mg of linvoseltamab-gcpt. Each mL contains 20 mg of linvoseltamab-gcpt, histidine (0.7 mg), L-histidine hydrochloride monohydrate (1.1 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>61755-056-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (61755-056-01) / 10 mL in 1 VIAL, SINGLE-DOSE (61755-056-00) </PackageDescription>
<NDC11Code>61755-0056-01</NDC11Code>
<ProductNDC>61755-056</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lynozyfic</ProprietaryName>
<NonProprietaryName>Linvoseltamab-gcpt</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250702</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761400</ApplicationNumber>
<LabelerName>Regeneron Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LINVOSELTAMAB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250702</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LYNOZYFIC is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).</IndicationAndUsage>
<Description>Linvoseltamab-gcpt, a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, is a recombinant human immunoglobulin (Ig)G4 antibody. Linvoseltamab-gcpt is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture. The molecular weight of linvoseltamab-gcpt is approximately 146 kDa. LYNOZYFIC (linvoseltamab-gcpt) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution with a pH 6.0. Each LYNOZYFIC 5 mg/2.5 mL vial contains 5 mg of linvoseltamab-gcpt. Each mL contains 2 mg of linvoseltamab-gcpt, histidine (0.7 mg), L-histidine hydrochloride monohydrate (1.1 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP. Each LYNOZYFIC 200 mg/10 mL vial contains 200 mg of linvoseltamab-gcpt. Each mL contains 20 mg of linvoseltamab-gcpt, histidine (0.7 mg), L-histidine hydrochloride monohydrate (1.1 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>73555-500-00</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (73555-500-00) </PackageDescription>
<NDC11Code>73555-0500-00</NDC11Code>
<ProductNDC>73555-500</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Revuforj</ProprietaryName>
<NonProprietaryName>Revumenib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218944</ApplicationNumber>
<LabelerName>Syndax Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>REVUMENIB CITRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Menin Inhibitor [EPC], Menin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REVUFORJ is a menin inhibitor indicated for. : 1 the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation as determined by an FDA-authorized test in adult and pediatric patients 1 year and older. (1), 2 the treatment of relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options. (1).</IndicationAndUsage>
<Description>REVUFORJ contains revumenib, a menin inhibitor. Revumenib is present as revumenib citrate hydrate with a chemical name of benzamide, N-ethyl-2-[[4-[7-[[trans-4- [(ethylsulfonyl)amino]cyclohexyl]methyl]-2,7-diazaspiro[3.5]non-2-yl]-5-pyrimidinyl]oxy]-5-fluoro-N-[1- methylethyl]-, 2-hydroxypropane-1,2,3-tricarboxylic acid, hydrate (1:1:1). The molecular formula is C32H47FN6O4S●C6H8O7●H2O with a molecular weight 840.96 g/mol. Revumenib citrate hydrate is a white to faint pink solid. Revumenib citrate hydrate is soluble at pH 1.2 and 6.8, and sparingly soluble at pH 4.5. The chemical structure is shown in Figure 1. Figure 1: Chemical structure of Revumenib Citrate. REVUFORJ is available as tablets for oral use. Each 25 mg strength tablet contains 25 mg revumenib, equivalent to 33.4 mg revumenib citrate, and the following inactive ingredients: microcrystalline cellulose, dicalcium phosphate, crospovidone, hypromellose, sodium bicarbonate, hydrophobic colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and red iron oxide. Each 110 mg strength tablet contains 110 mg revumenib, equivalent to 146.5 mg revumenib citrate, and the following inactive ingredients: microcrystalline cellulose, dicalcium phosphate, crospovidone, hypromellose, sodium bicarbonate, hydrophobic colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, red iron oxide, and yellow iron oxide. Each 160 mg strength tablet contains 160 mg revumenib equivalent to 213.2 mg revumenib citrate, and the following inactive ingredients: microcrystalline cellulose, dicalcium phosphate, crospovidone, hypromellose, sodium bicarbonate, hydrophobic colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, red iron oxide, and FD&C blue #2/indigo carmine aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>73555-501-00</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (73555-501-00) </PackageDescription>
<NDC11Code>73555-0501-00</NDC11Code>
<ProductNDC>73555-501</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Revuforj</ProprietaryName>
<NonProprietaryName>Revumenib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218944</ApplicationNumber>
<LabelerName>Syndax Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>REVUMENIB CITRATE</SubstanceName>
<StrengthNumber>110</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Menin Inhibitor [EPC], Menin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REVUFORJ is a menin inhibitor indicated for. : 1 the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation as determined by an FDA-authorized test in adult and pediatric patients 1 year and older. (1), 2 the treatment of relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options. (1).</IndicationAndUsage>
<Description>REVUFORJ contains revumenib, a menin inhibitor. Revumenib is present as revumenib citrate hydrate with a chemical name of benzamide, N-ethyl-2-[[4-[7-[[trans-4- [(ethylsulfonyl)amino]cyclohexyl]methyl]-2,7-diazaspiro[3.5]non-2-yl]-5-pyrimidinyl]oxy]-5-fluoro-N-[1- methylethyl]-, 2-hydroxypropane-1,2,3-tricarboxylic acid, hydrate (1:1:1). The molecular formula is C32H47FN6O4S●C6H8O7●H2O with a molecular weight 840.96 g/mol. Revumenib citrate hydrate is a white to faint pink solid. Revumenib citrate hydrate is soluble at pH 1.2 and 6.8, and sparingly soluble at pH 4.5. The chemical structure is shown in Figure 1. Figure 1: Chemical structure of Revumenib Citrate. REVUFORJ is available as tablets for oral use. Each 25 mg strength tablet contains 25 mg revumenib, equivalent to 33.4 mg revumenib citrate, and the following inactive ingredients: microcrystalline cellulose, dicalcium phosphate, crospovidone, hypromellose, sodium bicarbonate, hydrophobic colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and red iron oxide. Each 110 mg strength tablet contains 110 mg revumenib, equivalent to 146.5 mg revumenib citrate, and the following inactive ingredients: microcrystalline cellulose, dicalcium phosphate, crospovidone, hypromellose, sodium bicarbonate, hydrophobic colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, red iron oxide, and yellow iron oxide. Each 160 mg strength tablet contains 160 mg revumenib equivalent to 213.2 mg revumenib citrate, and the following inactive ingredients: microcrystalline cellulose, dicalcium phosphate, crospovidone, hypromellose, sodium bicarbonate, hydrophobic colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, red iron oxide, and FD&C blue #2/indigo carmine aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>73555-502-00</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (73555-502-00) </PackageDescription>
<NDC11Code>73555-0502-00</NDC11Code>
<ProductNDC>73555-502</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Revuforj</ProprietaryName>
<NonProprietaryName>Revumenib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA218944</ApplicationNumber>
<LabelerName>Syndax Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>REVUMENIB CITRATE</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Menin Inhibitor [EPC], Menin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REVUFORJ is a menin inhibitor indicated for. : 1 the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation as determined by an FDA-authorized test in adult and pediatric patients 1 year and older. (1), 2 the treatment of relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options. (1).</IndicationAndUsage>
<Description>REVUFORJ contains revumenib, a menin inhibitor. Revumenib is present as revumenib citrate hydrate with a chemical name of benzamide, N-ethyl-2-[[4-[7-[[trans-4- [(ethylsulfonyl)amino]cyclohexyl]methyl]-2,7-diazaspiro[3.5]non-2-yl]-5-pyrimidinyl]oxy]-5-fluoro-N-[1- methylethyl]-, 2-hydroxypropane-1,2,3-tricarboxylic acid, hydrate (1:1:1). The molecular formula is C32H47FN6O4S●C6H8O7●H2O with a molecular weight 840.96 g/mol. Revumenib citrate hydrate is a white to faint pink solid. Revumenib citrate hydrate is soluble at pH 1.2 and 6.8, and sparingly soluble at pH 4.5. The chemical structure is shown in Figure 1. Figure 1: Chemical structure of Revumenib Citrate. REVUFORJ is available as tablets for oral use. Each 25 mg strength tablet contains 25 mg revumenib, equivalent to 33.4 mg revumenib citrate, and the following inactive ingredients: microcrystalline cellulose, dicalcium phosphate, crospovidone, hypromellose, sodium bicarbonate, hydrophobic colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and red iron oxide. Each 110 mg strength tablet contains 110 mg revumenib, equivalent to 146.5 mg revumenib citrate, and the following inactive ingredients: microcrystalline cellulose, dicalcium phosphate, crospovidone, hypromellose, sodium bicarbonate, hydrophobic colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, red iron oxide, and yellow iron oxide. Each 160 mg strength tablet contains 160 mg revumenib equivalent to 213.2 mg revumenib citrate, and the following inactive ingredients: microcrystalline cellulose, dicalcium phosphate, crospovidone, hypromellose, sodium bicarbonate, hydrophobic colloidal silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, red iron oxide, and FD&C blue #2/indigo carmine aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>85766-059-00</NDCCode>
<PackageDescription>1000 mL in 1 BAG (85766-059-00) </PackageDescription>
<NDC11Code>85766-0059-00</NDC11Code>
<ProductNDC>85766-059</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Chloride</ProprietaryName>
<NonProprietaryName>Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19701209</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016677</ApplicationNumber>
<LabelerName>Sportpharm LLC</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>9</StrengthNumber>
<StrengthUnit>g/1000mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. 0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodialysis procedures.</IndicationAndUsage>
<Description>Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The nominal pH is 5.0 (4.5 to 7.0). Composition, osmolarity, and ionic concentration are shown below. 0.9% Sodium Chloride Injection, USPcontains 9 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2- ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
</NDC>
<NDC>
<NDCCode>0002-1445-09</NDCCode>
<PackageDescription>3 SYRINGE in 1 CARTON (0002-1445-09) / 1 mL in 1 SYRINGE (0002-1445-01) </PackageDescription>
<NDC11Code>00002-1445-09</NDC11Code>
<ProductNDC>0002-1445</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Taltz</ProprietaryName>
<NonProprietaryName>Ixekizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20160322</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125521</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>IXEKIZUMAB</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160322</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TALTZ® is a humanized interleukin-17A antagonist indicated for the treatment of: : 1 patients aged 6 years or older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. (1.1) , 2 adults with active psoriatic arthritis. (1.2) , 3 adults with active ankylosing spondylitis. (1.3) , 4 adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation. (1.4) .</IndicationAndUsage>
<Description>Ixekizumab is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) with neutralizing activity against IL-17A. Ixekizumab is produced by recombinant DNA technology in a recombinant mammalian cell line and purified using standard technology for bioprocessing. Ixekizumab is comprised of two identical light chain polypeptides of 219 amino acids each and two identical heavy chain polypeptides of 445 amino acids each and has a molecular weight of 146,158 Daltons for the protein backbone of the molecule. TALTZ injection is a sterile, preservative free, clear and colorless to slightly yellow solution, for subcutaneous use available as 80 mg of ixekizumab in a 1 mL single-dose prefilled autoinjector or a single-dose prefilled syringe, 40 mg of ixekizumab in a 0.5 mL single-dose prefilled syringe, or 20 mg of ixekizumab in a 0.25 mL single-dose prefilled syringe. The prefilled autoinjector and prefilled syringe each contain a 1 mL glass syringe with a fixed 27 gauge ½ inch needle. The TALTZ 80 mg prefilled autoinjector and prefilled syringe are manufactured to deliver 80 mg of ixekizumab. The TALTZ 40 mg prefilled syringe is manufactured to deliver 40 mg of ixekizumab. The TALTZ 20 mg prefilled syringe is manufactured to deliver 20 mg of ixekizumab. Each TALTZ 80 mg/mL single-dose autoinjector or TALTZ 80 mg/mL single-dose prefilled syringe is composed of ixekizumab (80 mg); Polysorbate 80, USP (0.3 mg); Sucrose, USP (80 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 – 6.2. Each TALTZ 40 mg/0.5 mL single-dose prefilled syringe is composed of ixekizumab (40 mg); Polysorbate 80, USP (0.15 mg); Sucrose, USP (40 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 – 6.2. Each TALTZ 20 mg/0.25 mL single-dose prefilled syringe is composed of ixekizumab (20 mg); Polysorbate 80, USP (0.08 mg); Sucrose, USP (20 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 – 6.2.</Description>
</NDC>
<NDC>
<NDCCode>0002-1445-11</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (0002-1445-11) / 1 mL in 1 SYRINGE (0002-1445-01) </PackageDescription>
<NDC11Code>00002-1445-11</NDC11Code>
<ProductNDC>0002-1445</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Taltz</ProprietaryName>
<NonProprietaryName>Ixekizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20160322</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125521</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>IXEKIZUMAB</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160322</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TALTZ® is a humanized interleukin-17A antagonist indicated for the treatment of: : 1 patients aged 6 years or older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. (1.1) , 2 adults with active psoriatic arthritis. (1.2) , 3 adults with active ankylosing spondylitis. (1.3) , 4 adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation. (1.4) .</IndicationAndUsage>
<Description>Ixekizumab is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) with neutralizing activity against IL-17A. Ixekizumab is produced by recombinant DNA technology in a recombinant mammalian cell line and purified using standard technology for bioprocessing. Ixekizumab is comprised of two identical light chain polypeptides of 219 amino acids each and two identical heavy chain polypeptides of 445 amino acids each and has a molecular weight of 146,158 Daltons for the protein backbone of the molecule. TALTZ injection is a sterile, preservative free, clear and colorless to slightly yellow solution, for subcutaneous use available as 80 mg of ixekizumab in a 1 mL single-dose prefilled autoinjector or a single-dose prefilled syringe, 40 mg of ixekizumab in a 0.5 mL single-dose prefilled syringe, or 20 mg of ixekizumab in a 0.25 mL single-dose prefilled syringe. The prefilled autoinjector and prefilled syringe each contain a 1 mL glass syringe with a fixed 27 gauge ½ inch needle. The TALTZ 80 mg prefilled autoinjector and prefilled syringe are manufactured to deliver 80 mg of ixekizumab. The TALTZ 40 mg prefilled syringe is manufactured to deliver 40 mg of ixekizumab. The TALTZ 20 mg prefilled syringe is manufactured to deliver 20 mg of ixekizumab. Each TALTZ 80 mg/mL single-dose autoinjector or TALTZ 80 mg/mL single-dose prefilled syringe is composed of ixekizumab (80 mg); Polysorbate 80, USP (0.3 mg); Sucrose, USP (80 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 – 6.2. Each TALTZ 40 mg/0.5 mL single-dose prefilled syringe is composed of ixekizumab (40 mg); Polysorbate 80, USP (0.15 mg); Sucrose, USP (40 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 – 6.2. Each TALTZ 20 mg/0.25 mL single-dose prefilled syringe is composed of ixekizumab (20 mg); Polysorbate 80, USP (0.08 mg); Sucrose, USP (20 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 – 6.2.</Description>
</NDC>
<NDC>
<NDCCode>0002-1445-27</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (0002-1445-27) / 1 mL in 1 SYRINGE (0002-1445-01) </PackageDescription>
<NDC11Code>00002-1445-27</NDC11Code>
<ProductNDC>0002-1445</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Taltz</ProprietaryName>
<NonProprietaryName>Ixekizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20160322</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125521</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>IXEKIZUMAB</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160322</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TALTZ® is a humanized interleukin-17A antagonist indicated for the treatment of: : 1 patients aged 6 years or older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. (1.1) , 2 adults with active psoriatic arthritis. (1.2) , 3 adults with active ankylosing spondylitis. (1.3) , 4 adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation. (1.4) .</IndicationAndUsage>
<Description>Ixekizumab is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) with neutralizing activity against IL-17A. Ixekizumab is produced by recombinant DNA technology in a recombinant mammalian cell line and purified using standard technology for bioprocessing. Ixekizumab is comprised of two identical light chain polypeptides of 219 amino acids each and two identical heavy chain polypeptides of 445 amino acids each and has a molecular weight of 146,158 Daltons for the protein backbone of the molecule. TALTZ injection is a sterile, preservative free, clear and colorless to slightly yellow solution, for subcutaneous use available as 80 mg of ixekizumab in a 1 mL single-dose prefilled autoinjector or a single-dose prefilled syringe, 40 mg of ixekizumab in a 0.5 mL single-dose prefilled syringe, or 20 mg of ixekizumab in a 0.25 mL single-dose prefilled syringe. The prefilled autoinjector and prefilled syringe each contain a 1 mL glass syringe with a fixed 27 gauge ½ inch needle. The TALTZ 80 mg prefilled autoinjector and prefilled syringe are manufactured to deliver 80 mg of ixekizumab. The TALTZ 40 mg prefilled syringe is manufactured to deliver 40 mg of ixekizumab. The TALTZ 20 mg prefilled syringe is manufactured to deliver 20 mg of ixekizumab. Each TALTZ 80 mg/mL single-dose autoinjector or TALTZ 80 mg/mL single-dose prefilled syringe is composed of ixekizumab (80 mg); Polysorbate 80, USP (0.3 mg); Sucrose, USP (80 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 – 6.2. Each TALTZ 40 mg/0.5 mL single-dose prefilled syringe is composed of ixekizumab (40 mg); Polysorbate 80, USP (0.15 mg); Sucrose, USP (40 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 – 6.2. Each TALTZ 20 mg/0.25 mL single-dose prefilled syringe is composed of ixekizumab (20 mg); Polysorbate 80, USP (0.08 mg); Sucrose, USP (20 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 – 6.2.</Description>
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