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edaravone

edaravone · EDARAVONE 60 mg/100mL · Injection, Solution · Intravenous · XGen Pharmaceuticals DJB, Inc.

NDC 39822-4510-01 · 1 VIAL, SINGLE-DOSE in 1 CARTON / 100 mL in 1 VIAL, SINGLE-DOSE · ANDA · View full market →

The short version

Just 3 companies supply this market — thin enough that a single exit would be felt immediately.

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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

WAC per package, as filed
$780.00
Reported to Texas DSHS · 2025 annual filing · Xgen Pharmaceuticals Djb

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

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
ANDA217565
TE code
Approval date
Oct 31, 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)

LabelerStrengthFirst seenLast seen
Gland Pharma LimitedEDARAVONE 30 mg/100mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedEDARAVONE 60 mg/100mLJul 15, 2026Sep 2, 2026
Piramal Critical Care Inc.EDARAVONE 30 mg/100mLJul 15, 2026Sep 2, 2026
XGen Pharmaceuticals DJB, Inc.EDARAVONE 60 mg/100mLJul 15, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "edaravone — NDC 39822-4510-01," retrieved September 3, 2026, https://drugdashboards.com/drug/39822451001.

Free to cite with attribution — see how the data is put together.