<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
84651-200-93
</NDCCode>
<PackageDescription>
3 BOTTLE in 1 CARTON (84651-200-93) / 30 CAPSULE in 1 BOTTLE (84651-200-30)
</PackageDescription>
<NDC11Code>
84651-0200-93
</NDC11Code>
<ProductNDC>
84651-200
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Ibtrozi
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Taletrectinib
</NonProprietaryName>
<DosageFormName>
CAPSULE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20250611
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA219713
</ApplicationNumber>
<LabelerName>
Nuvation Bio Inc.
</LabelerName>
<SubstanceName>
TALETRECTINIB ADIPATE
</SubstanceName>
<StrengthNumber>
272
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-06-18
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250613
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>