<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
87668-0100-1
</NDCCode>
<PackageDescription>
20 mL in 1 BAG (87668-0100-1)
</PackageDescription>
<NDC11Code>
87668-0100-01
</NDC11Code>
<ProductNDC>
87668-0100
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Waskyra
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Etuvetidigene Autotemcel
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20260723
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA125846
</ApplicationNumber>
<LabelerName>
Orphan Therapies LLC
</LabelerName>
<SubstanceName>
ETUVETIDIGENE AUTOTEMCEL
</SubstanceName>
<StrengthNumber>
1000000
</StrengthNumber>
<StrengthUnit>
U/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-07-25
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260723
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>