{
"NDC": {
"NDCCode": "70842-225-01",
"PackageDescription": "1 VIAL in 1 CARTON (70842-225-01) / 40 mL in 1 VIAL",
"NDC11Code": "70842-0225-01",
"ProductNDC": "70842-225",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kimyrsa",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Oritavancin Diphosphate",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210323",
"EndMarketingDate": null,
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214155",
"LabelerName": "Melinta Therapeutics, LLC",
"SubstanceName": "ORITAVANCIN DIPHOSPHATE",
"StrengthNumber": "1200",
"StrengthUnit": "mg/40mL",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Lipoglycopeptide Antibacterial [EPC], Lipoglycopeptides [CS]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210323",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}