{
"NDC": {
"NDCCode": "83831-183-04",
"PackageDescription": "1 VIAL in 1 CARTON (83831-183-04) / 4 mL in 1 VIAL",
"NDC11Code": "83831-0183-04",
"ProductNDC": "83831-183",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bendamustine Hydrochloride",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Bendamustine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260529",
"EndMarketingDate": null,
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219014",
"LabelerName": "Avyxa Pharma, LLC",
"SubstanceName": "BENDAMUSTINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/4mL",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260529",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}