<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
50909-1913-1
</NDCCode>
<PackageDescription>
12 kg in 1 DRUM (50909-1913-1)
</PackageDescription>
<NDC11Code>
50909-1913-01
</NDC11Code>
<ProductNDC>
50909-1913
</ProductNDC>
<ProductTypeName>
DRUG FOR FURTHER PROCESSING
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Paltusotine.hcl Sdd
</NonProprietaryName>
<DosageFormName>
POWDER
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20250925
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Hovione FarmaCiencia SA
</LabelerName>
<SubstanceName>
PALTUSOTINE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
15
</StrengthNumber>
<StrengthUnit>
kg/100kg
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2025-11-04
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
25-SEP-25
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>