<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
70842-120-06
</NDCCode>
<PackageDescription>
6 VIAL, SINGLE-DOSE in 1 CARTON (70842-120-06) / 2 g in 1 VIAL, SINGLE-DOSE (70842-120-01)
</PackageDescription>
<NDC11Code>
70842-0120-06
</NDC11Code>
<ProductNDC>
70842-120
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Vabomere
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Meropenem-vaborbactam
</NonProprietaryName>
<DosageFormName>
INJECTION, POWDER, FOR SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20171002
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA209776
</ApplicationNumber>
<LabelerName>
Melinta Therapeutics, LLC
</LabelerName>
<SubstanceName>
MEROPENEM; VABORBACTAM
</SubstanceName>
<StrengthNumber>
1; 1
</StrengthNumber>
<StrengthUnit>
g/2g; g/2g
</StrengthUnit>
<Pharm_Classes>
Carbapenems [CS], Penem Antibacterial [EPC], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-04-17
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20171002
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>