<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0078-1462-07
</NDCCode>
<PackageDescription>
5 kg in 1 BAG (0078-1462-07)
</PackageDescription>
<NDC11Code>
00078-1462-07
</NDC11Code>
<ProductNDC>
0078-1462
</ProductNDC>
<ProductTypeName>
BULK INGREDIENT
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Dabrafenib
</NonProprietaryName>
<DosageFormName>
POWDER
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20160412
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BULK INGREDIENT
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Novartis Pharmaceuticals Corporation
</LabelerName>
<SubstanceName>
DABRAFENIB MESYLATE
</SubstanceName>
<StrengthNumber>
1
</StrengthNumber>
<StrengthUnit>
kg/kg
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2025-03-06
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
12-APR-16
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>