<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
59651-988-25
</NDCCode>
<PackageDescription>
1 BOTTLE, GLASS in 1 CARTON (59651-988-25) / 25 mL in 1 BOTTLE, GLASS
</PackageDescription>
<NDC11Code>
59651-0988-25
</NDC11Code>
<ProductNDC>
59651-988
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Glycerol Phenylbutyrate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Glycerol Phenylbutyrate
</NonProprietaryName>
<DosageFormName>
LIQUID
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20260415
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA220313
</ApplicationNumber>
<LabelerName>
Aurobindo Pharma Limited
</LabelerName>
<SubstanceName>
GLYCEROL PHENYLBUTYRATE
</SubstanceName>
<StrengthNumber>
1.1
</StrengthNumber>
<StrengthUnit>
g/mL
</StrengthUnit>
<Pharm_Classes>
Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-04-16
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260415
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>