<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
81962-000-03
</NDCCode>
<PackageDescription>
25 VIAL in 1 CARTON (81962-000-03) / 20 mL in 1 VIAL
</PackageDescription>
<NDC11Code>
81962-0000-03
</NDC11Code>
<ProductNDC>
81962-000
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Meropenem
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Meropenem
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20230531
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA216154
</ApplicationNumber>
<LabelerName>
BROOKS STERISCIENCE LIMITED
</LabelerName>
<SubstanceName>
MEROPENEM
</SubstanceName>
<StrengthNumber>
500
</StrengthNumber>
<StrengthUnit>
mg/20mL
</StrengthUnit>
<Pharm_Classes>
Carbapenems [CS], Penem Antibacterial [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-01-28
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20230531
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>