{
"NDC": {
"NDCCode": "68462-803-60",
"PackageDescription": "1 BOTTLE in 1 CARTON (68462-803-60) / 60 CAPSULE in 1 BOTTLE",
"NDC11Code": "68462-0803-60",
"ProductNDC": "68462-803",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nintedanib",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Nintedanib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260709",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212555",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "NINTEDANIB ESYLATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260709",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}