<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
42052-2001-1
</NDCCode>
<PackageDescription>
1 BAG in 1 DRUM (42052-2001-1) / 24869 TABLET, COATED in 1 BAG
</PackageDescription>
<NDC11Code>
42052-2001-01
</NDC11Code>
<ProductNDC>
42052-2001
</ProductNDC>
<ProductTypeName>
DRUG FOR FURTHER PROCESSING
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Elexacaftor Tezacaftor Ivacaftor
</NonProprietaryName>
<DosageFormName>
TABLET, COATED
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20191021
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
HOVIONE LLC
</LabelerName>
<SubstanceName>
ELEXACAFTOR; IVACAFTOR; TEZACAFTOR
</SubstanceName>
<StrengthNumber>
100; 75; 50
</StrengthNumber>
<StrengthUnit>
mg/1; mg/1; mg/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2025-12-24
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
21-OCT-19
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>