<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0597-9257-86
</NDCCode>
<PackageDescription>
60 CARTON in 1 BOTTLE, PLASTIC (0597-9257-86) / 1 TABLET, FILM COATED in 1 CARTON
</PackageDescription>
<NDC11Code>
00597-9257-86
</NDC11Code>
<ProductNDC>
0597-9257
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Hernexeos
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Zongertinib
</NonProprietaryName>
<DosageFormName>
TABLET, FILM COATED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20250808
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA219042
</ApplicationNumber>
<LabelerName>
Boehringer Ingelheim Pharmaceuticals, Inc.
</LabelerName>
<SubstanceName>
ZONGERTINIB
</SubstanceName>
<StrengthNumber>
60
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Breast Cancer Resistance Protein Inhibitors [MoA], HER2/Neu/cerbB2 Antagonists [MoA], Kinase Inhibitor [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-01-02
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250808
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>