{
"NDC": {
"NDCCode": "65219-120-12",
"PackageDescription": "1 VIAL in 1 PACKAGE (65219-120-12) / 25 mL in 1 VIAL",
"NDC11Code": "65219-0120-12",
"ProductNDC": "65219-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dalbavancin Hydrochloride",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Dalbavancin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251110",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217591",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "DALBAVANCIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/25mL",
"Pharm_Classes": "Lipoglycopeptide Antibacterial [EPC], Lipoglycopeptides [CS]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251110",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}