<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
64842-0727-9
</NDCCode>
<PackageDescription>
1 BLISTER PACK in 1 CARTON (64842-0727-9) / 5 TABLET, FILM COATED in 1 BLISTER PACK
</PackageDescription>
<NDC11Code>
64842-0727-09
</NDC11Code>
<ProductNDC>
64842-0727
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Inqovi
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Cedazuridine And Decitabine
</NonProprietaryName>
<DosageFormName>
TABLET, FILM COATED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20200707
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA212576
</ApplicationNumber>
<LabelerName>
Taiho Pharmaceutical Co., Ltd.
</LabelerName>
<SubstanceName>
CEDAZURIDINE; DECITABINE
</SubstanceName>
<StrengthNumber>
100; 35
</StrengthNumber>
<StrengthUnit>
mg/1; mg/1
</StrengthUnit>
<Pharm_Classes>
Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-12-17
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20200825
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>