The short version
Just 3 companies supply this market — thin enough that a single exit would be felt immediately.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
edaravone
edaravone · EDARAVONE 60 mg/100mL · Injection, Solution · Intravenous · Gland Pharma Limited
NDC 68083-0501-01 · 1 POUCH in 1 CARTON / 1 BAG in 1 POUCH / 100 mL in 1 BAG · ANDA · 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.
Where it's made
- Gland Pharma LimitedIndiaanalysis · manufacture · pack
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 2 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill · avg $14,050.50 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- ANDA216199
- TE code
- AP
- Approval date
- May 6, 2024
- 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 edaravone (Injection, Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Gland Pharma Limited | EDARAVONE 30 mg/100mL | Jul 15, 2026 | Sep 2, 2026 |
| Gland Pharma Limited | EDARAVONE 60 mg/100mL | Jul 15, 2026 | Sep 2, 2026 |
| Piramal Critical Care Inc. | EDARAVONE 30 mg/100mL | Jul 15, 2026 | Sep 2, 2026 |
| XGen Pharmaceuticals DJB, Inc. | EDARAVONE 60 mg/100mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "edaravone — NDC 68083-0501-01," retrieved September 3, 2026, https://drugdashboards.com/drug/68083050101.
Free to cite with attribution — see how the data is put together.