<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
65044-3633-1
</NDCCode>
<PackageDescription>
1000 VIAL in 1 TRAY (65044-3633-1) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
</PackageDescription>
<NDC11Code>
65044-3633-01
</NDC11Code>
<ProductNDC>
65044-3633
</ProductNDC>
<ProductTypeName>
DRUG FOR FURTHER PROCESSING
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Bulevirtide
</NonProprietaryName>
<DosageFormName>
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20260522
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Jubilant HollisterStier LLC
</LabelerName>
<SubstanceName>
BULEVIRTIDE ACETATE
</SubstanceName>
<StrengthNumber>
8.5
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2026-06-04
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
22-MAY-26
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>