<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
42571-370-99
</NDCCode>
<PackageDescription>
10 VIAL in 1 CARTON (42571-370-99) / 5 mL in 1 VIAL (42571-370-92)
</PackageDescription>
<NDC11Code>
42571-0370-99
</NDC11Code>
<ProductNDC>
42571-370
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Brivaracetam
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Brivaracetam
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20260301
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA214880
</ApplicationNumber>
<LabelerName>
Micro Labs Limited
</LabelerName>
<SubstanceName>
BRIVARACETAM
</SubstanceName>
<StrengthNumber>
50
</StrengthNumber>
<StrengthUnit>
mg/5mL
</StrengthUnit>
<Pharm_Classes>
Epoxide Hydrolase Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule>
CV
</DEASchedule>
<Status>
Active
</Status>
<LastUpdate>
2026-03-03
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260301
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>