<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
72834-602-16
</NDCCode>
<PackageDescription>
473 mL in 1 BOTTLE (72834-602-16)
</PackageDescription>
<NDC11Code>
72834-0602-16
</NDC11Code>
<ProductNDC>
72834-602
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Baclofen
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Baclofen
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20240305
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA AUTHORIZED GENERIC
</MarketingCategoryName>
<ApplicationNumber>
NDA208193
</ApplicationNumber>
<LabelerName>
Sarras Health LLC
</LabelerName>
<SubstanceName>
BACLOFEN
</SubstanceName>
<StrengthNumber>
10
</StrengthNumber>
<StrengthUnit>
mg/5mL
</StrengthUnit>
<Pharm_Classes>
GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2026-01-01
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20251231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20240305
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>