{
"NDC": {
"NDCCode": "71288-039-16",
"PackageDescription": "6 VIAL, SINGLE-USE in 1 CARTON (71288-039-16) / 15 mL in 1 VIAL, SINGLE-USE (71288-039-15) ",
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"ProductNDC": "71288-039",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xenleta",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Lefamulin Acetate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190909",
"EndMarketingDate": null,
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211673",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "LEFAMULIN ACETATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/15mL",
"Pharm_Classes": "Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Diterpenes [CS], Pleuromutilin Antibacterial [EPC]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190909",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}