<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
70842-102-03
</NDCCode>
<PackageDescription>
10 VIAL, GLASS in 1 CARTON (70842-102-03) / 10.5 mL in 1 VIAL, GLASS (70842-102-01)
</PackageDescription>
<NDC11Code>
70842-0102-03
</NDC11Code>
<ProductNDC>
70842-102
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Baxdela
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Delafloxacin Meglumine
</NonProprietaryName>
<DosageFormName>
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20170619
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA208611
</ApplicationNumber>
<LabelerName>
Melinta Therapeutics, LLC
</LabelerName>
<SubstanceName>
DELAFLOXACIN MEGLUMINE
</SubstanceName>
<StrengthNumber>
300
</StrengthNumber>
<StrengthUnit>
mg/10.5mL
</StrengthUnit>
<Pharm_Classes>
Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-08-11
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20170619
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>