The short version
Only one company currently supplies this market — there is no backup if it stumbles.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Tregzi
allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq · Kit · Orca Biosystems Inc.
NDC 85866-0223-04 · 1 KIT in 1 CARTON * 100 mL in 1 BAG * 1 BAG in 1 CARTRIDGE / 15 mL in 1 BAG * 1 BAG in 1 CARTON / 30 mL in 1 BAG * 100 mL in 1 BAG · BLA · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Is this a "specialty" drug?
There's no legal definition — it meets 1 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- BLA125868
- TE code
- —
- Approval date
- —
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq (Kit)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Orca Biosystems Inc. | Jul 16, 2026 | Sep 3, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Tregzi — NDC 85866-0223-04," retrieved September 3, 2026, https://drugdashboards.com/drug/85866022304.
Free to cite with attribution — see how the data is put together.