<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
46014-8012-3
</NDCCode>
<PackageDescription>
30 CAPSULE in 1 BOTTLE (46014-8012-3)
</PackageDescription>
<NDC11Code>
46014-8012-03
</NDC11Code>
<ProductNDC>
46014-8012
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Tryvio
</NonProprietaryName>
<DosageFormName>
CAPSULE
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20241001
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Excella GmbH & Co. KG
</LabelerName>
<SubstanceName>
APROCITENTAN
</SubstanceName>
<StrengthNumber>
12.5
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2025-03-26
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
01-OCT-24
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>