<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
87262-160-02
</NDCCode>
<PackageDescription>
1 INJECTION, SUSPENSION in 1 BAG (87262-160-02)
</PackageDescription>
<NDC11Code>
87262-0160-02
</NDC11Code>
<ProductNDC>
87262-160
</ProductNDC>
<ProductTypeName>
CELLULAR THERAPY
</ProductTypeName>
<ProprietaryName>
Tecelra
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Afamitresgene Autoleucel
</NonProprietaryName>
<DosageFormName>
INJECTION, SUSPENSION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20260119
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA125789
</ApplicationNumber>
<LabelerName>
USWM CT, LLC
</LabelerName>
<SubstanceName>
AFAMITRESGENE AUTOLEUCEL
</SubstanceName>
<StrengthNumber>
10000000000
</StrengthNumber>
<StrengthUnit>
1/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-01-19
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260119
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>