TREGZI

Product NDC: 85866-223
11-digit product format: 858660223
Labeler code: 85866
Product ID: 85866-223_ffffa405-7551-4adc-9a7c-98750b100095
Type: CELLULAR THERAPY
Nonproprietary name: allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq
Dosage form: KIT
Labeler: Orca Biosystems Inc.
Application: BLA125868
Marketing category: BLA
Marketing start: 2026-06-30
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: TREGZI
Listing expiration: 2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2747373	Internal RxNorm lookup
2747379	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2157e11b-87c3-4d54-a225-81b341e4e21a	Available on FDA.report

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TREGZI	ALLOGENEIC REGULATORY T CELL IMMUNOTHERAPY WITH HSPC AND T CELLS-VLDQ	Orca Biosystems Inc.	2157e11b-87c3-4d54-a225-81b341e4e21a	2026-06-30	Warnings, Adverse reactions	Exact identifier application number: BLA125868 ndc (product): 85866-223

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125868	tregzi	allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq	351(a)	Rx	2026-09-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85866-223-04	85866022304	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)	1 kit	2026-06-30	No	No	Current