<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
63069-102-01
</NDCCode>
<PackageDescription>
1 TABLET, FILM COATED in 1 DRUM (63069-102-01)
</PackageDescription>
<NDC11Code>
63069-0102-01
</NDC11Code>
<ProductNDC>
63069-102
</ProductNDC>
<ProductTypeName>
DRUG FOR FURTHER PROCESSING
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Macitentan And Tadalafil
</NonProprietaryName>
<DosageFormName>
TABLET, FILM COATED
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20240322
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
PENN PHARMACEUTICAL SERVICES LIMITED
</LabelerName>
<SubstanceName>
MACITENTAN; TADALAFIL
</SubstanceName>
<StrengthNumber>
10; 20
</StrengthNumber>
<StrengthUnit>
mg/1; mg/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2025-12-31
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
22-MAR-24
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>