{
"NDC": {
"NDCCode": "82928-300-04",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (82928-300-04) / 1 TABLET in 1 BLISTER PACK (82928-300-01) ",
"NDC11Code": "82928-0300-04",
"ProductNDC": "82928-300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ekterly",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Sebetralstat",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250707",
"EndMarketingDate": null,
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219301",
"LabelerName": "KalVista Pharmaceuticals Ltd",
"SubstanceName": "SEBETRALSTAT",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kallikrein Inhibitors [MoA], Plasma Kallikrein Inhibitor [EPC]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250707",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}