{
"NDC": {
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"PackageDescription": "1 VIAL in 1 CARTON (70069-830-01) / 25 mL in 1 VIAL",
"NDC11Code": "70069-0830-01",
"ProductNDC": "70069-830",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dalbavancin",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Dalbavancin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260727",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219604",
"LabelerName": "Somerset Therapeutics, LLC",
"SubstanceName": "DALBAVANCIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/25mL",
"Pharm_Classes": "Lipoglycopeptide Antibacterial [EPC], Lipoglycopeptides [CS]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260727",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}