<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
82983-417-47
</NDCCode>
<PackageDescription>
473 mL in 1 BOTTLE, PLASTIC (82983-417-47)
</PackageDescription>
<NDC11Code>
82983-0417-47
</NDC11Code>
<ProductNDC>
82983-417
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Phenobarbital Oral Solution
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Phenobarbital Oral
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20251105
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
UNAPPROVED DRUG OTHER
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Ajenat Pharmaceuticals LLC
</LabelerName>
<SubstanceName>
PHENOBARBITAL
</SubstanceName>
<StrengthNumber>
20
</StrengthNumber>
<StrengthUnit>
mg/5mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule>
CIV
</DEASchedule>
<Status>
Active
</Status>
<LastUpdate>
2025-12-30
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251105
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>