What is NDC 85866-223?

85866-223 is the product NDC for Tregzi kit, listed with the FDA by Orca Biosystems Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Tregzi (Allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq).

Orca Biosystems Inc., NDC labeler code 85866. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tregzi?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tregzi NDC 85866-223 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)85866-223Labeler and product segments. Claims need a package NDC.

Product NDC at billing width85866-0223Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
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)Marketed from Jun 30, 2026

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Tregzi
Generic name (nonproprietary): allogeneic regulatory t cell immunotherapy with hspc and t cells-vldq
Dosage form: Kit
Labeler: Orca Biosystems Inc.NDC labeler code 85866
Product type: Cellular therapy
Marketing category: BLA — Biologics License ApplicationApplication BLA 125868
Marketing start: Jun 30, 2026
Listing expires: Dec 31, 2027
Identifiers: Product ID 85866-223_ffffa405-7551-4adc-9a7c-98750b100095SPL ID ffffa405-7551-4adc-9a7c-98750b100095SPL set ID 2157e11b-87c3-4d54-a225-81b341e4e21aRxCUI 2747373, 2747379

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N485866022304 followed by a unit qualifier and the quantity

Package 85866-0223-04. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jun 30, 2026.

Indications (excerpt from the label)

TREGZI is indicated for use in matched donor hematopoietic stem cell transplantation with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease-free survival, in the treatment of adults with hematological malignancies. TREGZI™ is an allogeneic regulatory T cell-based immunotherapy with hematopoietic stem and progenitor cells and T cells indicated for use in matched donor hematopoietic stem cell transplantation with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease (cGVHD)-free survival, in the treatment of adults with hematological …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 85866-223

What is NDC 85866-223?: 85866-223 is the product NDC for Tregzi kit, listed with the FDA by Orca Biosystems Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tregzi (Allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq).
Who is the labeler?: Orca Biosystems Inc., NDC labeler code 85866. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tregzi?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.