{
"NDC": {
"NDCCode": "70771-1908-8",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (70771-1908-8) / 14 TABLET, FOR SUSPENSION in 1 BLISTER PACK (70771-1908-7) ",
"NDC11Code": "70771-1908-08",
"ProductNDC": "70771-1908",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bosentan",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Bosentan",
"DosageFormName": "TABLET, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20260217",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213981",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "BOSENTAN",
"StrengthNumber": "32",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260217",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}