<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
70594-075-02
</NDCCode>
<PackageDescription>
10 VIAL, GLASS in 1 CARTON (70594-075-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (70594-075-01)
</PackageDescription>
<NDC11Code>
70594-0075-02
</NDC11Code>
<ProductNDC>
70594-075
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Meropenem
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Meropenem
</NonProprietaryName>
<DosageFormName>
INJECTION, POWDER, FOR SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20210628
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA206141
</ApplicationNumber>
<LabelerName>
Xellia Pharmaceuticals USA LLC
</LabelerName>
<SubstanceName>
MEROPENEM
</SubstanceName>
<StrengthNumber>
500
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Carbapenems [CS], Penem Antibacterial [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-12-12
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20251231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20210628
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>