<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
72000-120-06
</NDCCode>
<PackageDescription>
6 VIAL, SINGLE-USE in 1 CARTON (72000-120-06) / 15 mL in 1 VIAL, SINGLE-USE (72000-120-01)
</PackageDescription>
<NDC11Code>
72000-0120-06
</NDC11Code>
<ProductNDC>
72000-120
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Xenleta
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Lefamulin Acetate
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20190909
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA211673
</ApplicationNumber>
<LabelerName>
Nabriva Therapeutics US, Inc.
</LabelerName>
<SubstanceName>
LEFAMULIN ACETATE
</SubstanceName>
<StrengthNumber>
150
</StrengthNumber>
<StrengthUnit>
mg/15mL
</StrengthUnit>
<Pharm_Classes>
Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Diterpenes [CS], Pleuromutilin Antibacterial [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2026-01-01
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20251231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20190909
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>