<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
76282-789-58
</NDCCode>
<PackageDescription>
4 CARTON in 1 CARTON (76282-789-58) / 4 BLISTER PACK in 1 CARTON (76282-789-46) / 7 CAPSULE in 1 BLISTER PACK (76282-789-45)
</PackageDescription>
<NDC11Code>
76282-0789-58
</NDC11Code>
<ProductNDC>
76282-789
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Nilotinib
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Nilotinib
</NonProprietaryName>
<DosageFormName>
CAPSULE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20251114
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA218922
</ApplicationNumber>
<LabelerName>
EXELAN PHARMACEUTICALS INC.
</LabelerName>
<SubstanceName>
NILOTINIB
</SubstanceName>
<StrengthNumber>
150
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-11-18
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251114
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>