<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
61958-3104-1
</NDCCode>
<PackageDescription>
30 VIAL, SINGLE-DOSE in 1 CARTON (61958-3104-1) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (61958-3104-2)
</PackageDescription>
<NDC11Code>
61958-3104-01
</NDC11Code>
<ProductNDC>
61958-3104
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Hepcludex
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Bulevirtide
</NonProprietaryName>
<DosageFormName>
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
</DosageFormName>
<RouteName>
SUBCUTANEOUS
</RouteName>
<StartMarketingDate>
20260522
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA761468
</ApplicationNumber>
<LabelerName>
Gilead Sciences, Inc.
</LabelerName>
<SubstanceName>
BULEVIRTIDE ACETATE
</SubstanceName>
<StrengthNumber>
8.5
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-05-25
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260522
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>