<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
51991-981-01
</NDCCode>
<PackageDescription>
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-981-01)
</PackageDescription>
<NDC11Code>
51991-0981-01
</NDC11Code>
<ProductNDC>
51991-981
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Zolpidem Tartrate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Zolpidem Tartrate
</NonProprietaryName>
<DosageFormName>
TABLET, EXTENDED RELEASE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20260301
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA213592
</ApplicationNumber>
<LabelerName>
Breckenridge Pharmaceutical, Inc.
</LabelerName>
<SubstanceName>
ZOLPIDEM TARTRATE
</SubstanceName>
<StrengthNumber>
6.25
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Central Nervous System Depression [PE], GABA A Receptor Positive Modulators [MoA], gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]
</Pharm_Classes>
<DEASchedule>
CIV
</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>