<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0173-0906-13
</NDCCode>
<PackageDescription>
30 TABLET, FILM COATED in 1 BOTTLE (0173-0906-13)
</PackageDescription>
<NDC11Code>
00173-0906-13
</NDC11Code>
<ProductNDC>
0173-0906
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Jesduvroq
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Daprodustat
</NonProprietaryName>
<DosageFormName>
TABLET, FILM COATED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20230201
</StartMarketingDate>
<EndMarketingDate>
20270430
</EndMarketingDate>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA216951
</ApplicationNumber>
<LabelerName>
GlaxoSmithKline LLC
</LabelerName>
<SubstanceName>
DAPRODUSTAT
</SubstanceName>
<StrengthNumber>
4
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors [MoA], Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-03-15
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage>
20230201
</StartMarketingDatePackage>
<EndMarketingDatePackage>
20270430
</EndMarketingDatePackage>
<SamplePackage>
N
</SamplePackage>
</NDC>