Tregzi Kit
NDC Package 85866-223-04

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Tregzi (allogeneic regulatory t cell immunotherapy with hspc and t cells-vldq) kits is 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. This formulation utilizes a kit delivery system. Marketed by Orca Biosystems Inc., this product is identified by NDC 85866-223 and is authorized under FDA application BLA125868.

Identification & Billing

NDC Package Code
85866-223-04
Package Description
1 KIT in 1 CARTON * 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)
Product Code
85866-223
11-Digit Billing Format
85866022304

Clinical Specifications

Proprietary Name
Tregzi
Non-Proprietary Name
Allogeneic Regulatory T Cell Immunotherapy With Hspc And T Cells-vldq
Dosage Form
Kit - A packaged collection of related material.
Usage Information
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.

Regulatory & Marketing

Labeler Name
Orca Biosystems Inc.
Product Type
Cellular Therapy
FDA Application #
BLA125868
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-30-2026
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage
  • 85866 - Orca Biosystems Inc.
    • 85866-223 - Tregzi
      • 85866-223-04 - 1 KIT in 1 CARTON * 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)

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 85866-223-04 identifies a specific commercial package of 1 kit in 1 carton * 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) of Tregzi, a cellular therapy labeled by Orca Biosystems Inc.. This kit is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Orca Biosystems Inc. on June 30, 2026. The current certification is valid through December 31, 2027.

How is this Orca Biosystems Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85866022304. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
85866-223-04
11-Digit CMS (5-4-2)
85866-0223-04

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.