<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
83246-065-01
</NDCCode>
<PackageDescription>
100 VIAL in 1 BOX (83246-065-01) / 10 mL in 1 VIAL
</PackageDescription>
<NDC11Code>
83246-0065-01
</NDC11Code>
<ProductNDC>
83246-065
</ProductNDC>
<ProductTypeName>
DRUG FOR FURTHER PROCESSING
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Efanesoctocog Alfa
</NonProprietaryName>
<DosageFormName>
POWDER, FOR SOLUTION
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20240807
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Genzyme Ireland Limited
</LabelerName>
<SubstanceName>
EFANESOCTOCOG ALFA
</SubstanceName>
<StrengthNumber>
4000
</StrengthNumber>
<StrengthUnit>
[iU]/3mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2024-09-19
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20251231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
07-AUG-24
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>