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Tirofiban

Tirofiban · TIROFIBAN HYDROCHLORIDE 12.5 mg/250mL · Injection, Solution · Intravenous · Eugia US LLC

NDC 55150-0430-01 · 1 POUCH in 1 CARTON / 1 BAG in 1 POUCH / 250 mL in 1 BAG · ANDA · View full market →

The short version

Just 3 companies supply this market — thin enough that a single exit would be felt immediately. One of its named manufacturing plants, Eugia Pharma Specialities Limited, failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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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
$227.05
Reported to Texas DSHS · 2026 annual filing · Eugia Us Llc

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

Medicare Part B (ASP)

Payment limit per 0.25 MG
$2.917
HCPCS J3246 · Jul 1, 2026 quarter · typically ASP + 6%

Supply fragility

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

Where it's made

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 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
ANDA216379
TE code
AP
Approval date
May 1, 2023
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · OngoingApr 21, 2025
    Eugia US LLC — Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
  • Class II · OngoingApr 21, 2025
    Eugia US LLC — Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.

Manufacturers of Tirofiban (Injection, Solution)

LabelerStrengthFirst seenLast seen
Eugia US LLCTIROFIBAN HYDROCHLORIDE 12.5 mg/250mLJul 15, 2026Sep 2, 2026
Eugia US LLCTIROFIBAN HYDROCHLORIDE 5 mg/100mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedTIROFIBAN HYDROCHLORIDE 12.5 mg/250mLJul 15, 2026Sep 2, 2026
Medicure International IncTIROFIBAN HYDROCHLORIDE 3.75 mg/15mLJul 15, 2026Aug 31, 2026
Medicure International IncTIROFIBAN HYDROCHLORIDE 5 mg/100mLJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Tirofiban — NDC 55150-0430-01," retrieved September 3, 2026, https://drugdashboards.com/drug/55150043001.

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