{
"NDC": {
"NDCCode": "70710-1166-5",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (70710-1166-5) / 3 TABLET, FILM COATED in 1 BLISTER PACK (70710-1166-4) ",
"NDC11Code": "70710-1166-05",
"ProductNDC": "70710-1166",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Macitentan",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Macitentan",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251105",
"EndMarketingDate": "20251106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211224",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "MACITENTAN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]",
"DEASchedule": null,
"Status": "Deprecated",
"LastUpdate": "2025-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": null,
"StartMarketingDatePackage": "20251105",
"EndMarketingDatePackage": "20251106",
"SamplePackage": "N"
}
}