<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
85866-223-04
</NDCCode>
<PackageDescription>
1 KIT in 1 CARTON (85866-223-04) * 100 mL in 1 BAG (85866-124-01) * 1 BAG in 1 CARTRIDGE (85866-126-02) / 15 mL in 1 BAG (85866-126-01) * 1 BAG in 1 CARTON (85866-127-02) / 30 mL in 1 BAG (85866-127-01) * 100 mL in 1 BAG (85866-125-01)
</PackageDescription>
<NDC11Code>
85866-0223-04
</NDC11Code>
<ProductNDC>
85866-223
</ProductNDC>
<ProductTypeName>
CELLULAR THERAPY
</ProductTypeName>
<ProprietaryName>
Tregzi
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Allogeneic Regulatory T Cell Immunotherapy With Hspc And T Cells-vldq
</NonProprietaryName>
<DosageFormName>
KIT
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20260630
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA125868
</ApplicationNumber>
<LabelerName>
Orca Biosystems Inc.
</LabelerName>
<SubstanceName/>
<StrengthNumber/>
<StrengthUnit/>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-07-16
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260630
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>