{
"NDC": {
"NDCCode": "71288-034-50",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-034-50) / 25 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "71288-0034-50",
"ProductNDC": "71288-034",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dalbavancin",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Dalbavancin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251126",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218929",
"LabelerName": "Meitheal Pharmaceuticals Inc",
"SubstanceName": "DALBAVANCIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/25mL",
"Pharm_Classes": "Lipoglycopeptide Antibacterial [EPC], Lipoglycopeptides [CS]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251126",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}