<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
70710-2193-5
</NDCCode>
<PackageDescription>
1 BOTTLE in 1 CARTON (70710-2193-5) / 25 mL in 1 BOTTLE
</PackageDescription>
<NDC11Code>
70710-2193-05
</NDC11Code>
<ProductNDC>
70710-2193
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Glycerol Phenylbutyrate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Glycerol Phenylbutyrate
</NonProprietaryName>
<DosageFormName>
LIQUID
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20260504
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA220568
</ApplicationNumber>
<LabelerName>
Zydus Pharmaceuticals USA Inc.
</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>
2026-05-05
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260504
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>