{
"NDC": {
"NDCCode": "0006-5092-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0006-5092-01) ",
"NDC11Code": "00006-5092-01",
"ProductNDC": "0006-5092",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Idvynso",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Doravirine, Islatravir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260423",
"EndMarketingDate": null,
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216964",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "DORAVIRINE; ISLATRAVIR ANHYDROUS",
"StrengthNumber": "100; .25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260423",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}