{
"NDC": {
"NDCCode": "68475-204-02",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (68475-204-02) / 15 CAPSULE in 1 BLISTER PACK (68475-204-01) ",
"NDC11Code": "68475-0204-02",
"ProductNDC": "68475-204",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Miglustat",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Miglustat",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250507",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219111",
"LabelerName": "Navinta LLC",
"SubstanceName": "MIGLUSTAT",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Enzyme Stabilizer [EPC], Enzyme Stabilizers [MoA], Glucosylceramide Synthase Inhibitor [EPC], Glucosylceramide Synthase Inhibitors [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250507",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}