<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
17856-0620-1
</NDCCode>
<PackageDescription>
72 CUP, UNIT-DOSE in 1 CASE (17856-0620-1) / 2.5 mL in 1 CUP, UNIT-DOSE
</PackageDescription>
<NDC11Code>
17856-0620-01
</NDC11Code>
<ProductNDC>
17856-0620
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Baclofen
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Baclofen
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20231012
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA AUTHORIZED GENERIC
</MarketingCategoryName>
<ApplicationNumber>
NDA208193
</ApplicationNumber>
<LabelerName>
Atlantic Biologicals Corp.
</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>
Active
</Status>
<LastUpdate>
2026-05-05
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260430
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>