<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
84976-001-01
</NDCCode>
<PackageDescription>
1 VIAL in 1 CARTON (84976-001-01) / 5 mL in 1 VIAL
</PackageDescription>
<NDC11Code>
84976-0001-01
</NDC11Code>
<ProductNDC>
84976-001
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Avlayah
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Tividenofusp Alfa-eknm
</NonProprietaryName>
<DosageFormName>
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20260406
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA761485
</ApplicationNumber>
<LabelerName>
Denali Therapeutics Inc.
</LabelerName>
<SubstanceName>
TIVIDENOFUSP ALFA
</SubstanceName>
<StrengthNumber>
150
</StrengthNumber>
<StrengthUnit>
mg/5mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-04-06
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260406
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>