{
"NDC": {
"NDCCode": "59676-577-30",
"PackageDescription": "30 TABLET, FOR SUSPENSION in 1 BOTTLE (59676-577-30) ",
"NDC11Code": "59676-0577-30",
"ProductNDC": "59676-577",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prezcobix Ped",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Darunavir Ethanolate And Cobicistat",
"DosageFormName": "TABLET, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20260227",
"EndMarketingDate": null,
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA220092",
"LabelerName": "Janssen Products, LP",
"SubstanceName": "DARUNAVIR ETHANOLATE; COBICISTAT",
"StrengthNumber": "90; 600",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260227",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}