{
"NDC": {
"NDCCode": "51167-135-01",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (51167-135-01) / 21 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "51167-0135-01",
"ProductNDC": "51167-135",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alyftrek",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Vanzacaftor, Tezacaftor, And Deutivacaftor",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20241220",
"EndMarketingDate": null,
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA218730",
"LabelerName": "Vertex Pharmaceuticals Incorporated",
"SubstanceName": "DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR",
"StrengthNumber": "50; 20; 4",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Chloride Channel Activation Potentiators [MoA], Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC], Cytochrome P450 2C9 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241220",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}