DrugDashboards

Epoprostenol

Epoprostenol · EPOPROSTENOL 1.5 mg/10mL · Injection, Powder, Lyophilized, For Solution · Intravenous · Mylan Institutional LLC

NDC 67457-0588-10 · 1 VIAL in 1 CARTON / 10 mL in 1 VIAL · ANDA · View full market →

The short version

5 companies supply this market — a reasonable cushion if one runs into trouble.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

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
$44.50
Reported to Texas DSHS · 2026 annual filing · Mylan Institutional Inc.

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

Medicare Part B (ASP)

Payment limit per 0.5 MG
$16.918
HCPCS J1325 · Jul 1, 2026 quarter · typically ASP + 6%

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
ANDA213913
TE code
AP2
Approval date
Jun 12, 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 Epoprostenol (Injection, Powder, Lyophilized, For Solution)

LabelerStrengthFirst seenLast seen
Actelion Pharmaceuticals US, Inc.EPOPROSTENOL .5 mg/10mLJul 15, 2026Sep 2, 2026
Actelion Pharmaceuticals US, Inc.EPOPROSTENOL 1.5 mg/10mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedEPOPROSTENOL 1.5 mg/10mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedEPOPROSTENOL .5 mg/10mLJul 15, 2026Sep 2, 2026
Mylan Institutional LLCEPOPROSTENOL .5 mg/10mLJul 15, 2026Sep 2, 2026
Mylan Institutional LLCEPOPROSTENOL 1.5 mg/10mLJul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.EPOPROSTENOL SODIUM .5 mg/10mLJul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.EPOPROSTENOL SODIUM 1.5 mg/10mLJul 15, 2026Sep 2, 2026
Wasserburger Arzneimittelwerk GmbHEPOPROSTENOL 1.5 mg/10mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Epoprostenol — NDC 67457-0588-10," retrieved September 3, 2026, https://drugdashboards.com/drug/67457058810.

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