<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
83786-009-03
</NDCCode>
<PackageDescription>
1 BOTTLE, GLASS in 1 BOTTLE, GLASS (83786-009-03) / 10 kg in 1 BOTTLE, GLASS
</PackageDescription>
<NDC11Code>
83786-0009-03
</NDC11Code>
<ProductNDC>
83786-009
</ProductNDC>
<ProductTypeName>
BULK INGREDIENT
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Glycerol Phenylbutyrate
</NonProprietaryName>
<DosageFormName>
LIQUID
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20241213
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BULK INGREDIENT
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
LUPIN MANUFACTURING SOLUTIONS LIMITED
</LabelerName>
<SubstanceName>
GLYCEROL PHENYLBUTYRATE
</SubstanceName>
<StrengthNumber>
1
</StrengthNumber>
<StrengthUnit>
kg/kg
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2025-01-01
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20251231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
13-DEC-24
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>