<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
50881-026-01
</NDCCode>
<PackageDescription>
14 TABLET in 1 BOTTLE, PLASTIC (50881-026-01)
</PackageDescription>
<NDC11Code>
50881-0026-01
</NDC11Code>
<ProductNDC>
50881-026
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Pemazyre
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Pemigatinib
</NonProprietaryName>
<DosageFormName>
TABLET
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20200417
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA213736
</ApplicationNumber>
<LabelerName>
Incyte Corporation
</LabelerName>
<SubstanceName>
PEMIGATINIB
</SubstanceName>
<StrengthNumber>
4.5
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Kinase Inhibitor [EPC], Kinase Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-08-22
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20200417
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>