Lynozyfic
linvoseltamab-gcpt · LINVOSELTAMAB 5 mg/2.5mL · Injection, Solution, Concentrate · Intravenous · Regeneron Pharmaceuticals, Inc.
NDC 61755-0054-01 · 1 VIAL, SINGLE-DOSE in 1 CARTON / 2.5 mL in 1 VIAL, SINGLE-DOSE · 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.
Estimated fill cost
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicare Part B (ASP)
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- Regeneron Pharmaceuticals, Inc.United Statesanalysis · api manufacture
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Is this a "specialty" drug?
There's no legal definition — it meets 3 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program · Lynozyfic
Regulatory
- Application
- BLA761400
- 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 linvoseltamab-gcpt (Injection, Solution, Concentrate)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | LINVOSELTAMAB 200 mg/10mL | Jul 15, 2026 | Jul 29, 2026 |
| Regeneron Pharmaceuticals, Inc. | LINVOSELTAMAB 5 mg/2.5mL | Jul 15, 2026 | Jul 29, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Lynozyfic — NDC 61755-0054-01," retrieved September 3, 2026, https://drugdashboards.com/drug/61755005401.
Free to cite with attribution — see how the data is put together.