{
"NDC": {
"NDCCode": "61958-3601-1",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-3601-1) ",
"NDC11Code": "61958-3601-01",
"ProductNDC": "61958-3601",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bixlenvo",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Bictegravir/lenacapavir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260827",
"EndMarketingDate": null,
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA221104",
"LabelerName": "Gilead Sciences, Inc.",
"SubstanceName": "BICTEGRAVIR SODIUM; LENACAPAVIR SODIUM",
"StrengthNumber": "75; 50",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Capsid Inhibitors [MoA], Human Immunodeficiency Virus 1 Capsid Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260827",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}