<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
54442-104-02
</NDCCode>
<PackageDescription>
10 VIAL in 1 CARTON (54442-104-02) > 30 mL in 1 VIAL (54442-104-01)
</PackageDescription>
<NDC11Code>
54442-0104-02
</NDC11Code>
<ProductNDC>
54442-104
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Meropenem
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Meropenem
</NonProprietaryName>
<DosageFormName>
INJECTION, POWDER, FOR SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20151218
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA204854
</ApplicationNumber>
<LabelerName>
Daewoong Pharmaceutical Co., Ltd.
</LabelerName>
<SubstanceName>
MEROPENEM
</SubstanceName>
<StrengthNumber>
1
</StrengthNumber>
<StrengthUnit>
g/30mL
</StrengthUnit>
<Pharm_Classes>
Carbapenems [Chemical/Ingredient],Penem Antibacterial [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2017-01-13
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>