<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
84146-0001-1
</NDCCode>
<PackageDescription>
16 VIAL, SINGLE-USE in 1 BOX (84146-0001-1) / 10 mL in 1 VIAL, SINGLE-USE
</PackageDescription>
<NDC11Code>
84146-0001-01
</NDC11Code>
<ProductNDC>
84146-0001
</ProductNDC>
<ProductTypeName>
DRUG FOR FURTHER PROCESSING
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Lovo-cel Lyfgenia
</NonProprietaryName>
<DosageFormName>
INJECTION, SUSPENSION
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20231208
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Henogen
</LabelerName>
<SubstanceName>
LOVOTIBEGLOGENE AUTOTEMCEL
</SubstanceName>
<StrengthNumber>
1
</StrengthNumber>
<StrengthUnit>
g/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2025-10-13
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
08-DEC-23
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>