<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
76282-786-60
</NDCCode>
<PackageDescription>
60 CAPSULE in 1 BOTTLE (76282-786-60)
</PackageDescription>
<NDC11Code>
76282-0786-60
</NDC11Code>
<ProductNDC>
76282-786
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Nintedanib Capsules, 100 Mg And 150 Mg
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Nintedanib
</NonProprietaryName>
<DosageFormName>
CAPSULE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20260507
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA212609
</ApplicationNumber>
<LabelerName>
EXELAN PHARMACEUTICALS INC.
</LabelerName>
<SubstanceName>
NINTEDANIB ESYLATE
</SubstanceName>
<StrengthNumber>
100
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-05-11
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260507
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>