{
"NDC": {
"NDCCode": "70121-2250-1",
"PackageDescription": "1 VIAL in 1 CARTON (70121-2250-1) / 5.5 mL in 1 VIAL",
"NDC11Code": "70121-2250-01",
"ProductNDC": "70121-2250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Romidepsin",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Romidepsin",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260602",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219099",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "ROMIDEPSIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Bile Salt Export Pump Inhibitors [MoA], Histone Deacetylase Inhibitor [EPC], Histone Deacetylase Inhibitors [MoA], Organic Anion Transporter 1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260602",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}