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Icatibant

Icatibant · ICATIBANT ACETATE 30 mg/3mL · Injection, Solution · Subcutaneous · Eugia US LLC

NDC 55150-0351-03 · 3 CARTON in 1 CARTON / 1 SYRINGE, GLASS in 1 CARTON / 3 mL in 1 SYRINGE, GLASS · ANDA · View full market →

The short version

4 companies supply this market — a reasonable cushion if one runs into trouble. 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
$3,000.00
Reported to Texas DSHS · 2026 annual filing · Eugia Us Llc

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

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 2 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $13,272.35 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA213521
TE code
AP
Approval date
Aug 14, 2023
Patents / exclusivity
None on file

Shortage history

  • Planned discontinuation Icatibant Acetate, Injection, 10 mg/1 mL (NDC 63323-574-86)May 7, 2026
  • Planned discontinuation Icatibant Acetate, Injection, 10 mg/1 mL (NDC 63323-574-93)May 7, 2026

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Icatibant (Injection, Solution)

LabelerStrengthFirst seenLast seen
Eugia US LLCICATIBANT ACETATE 30 mg/3mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCICATIBANT ACETATE 10 mg/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.ICATIBANT ACETATE 30 mg/3mLJul 15, 2026Sep 2, 2026
Teva Pharmaceuticals USA, Inc.ICATIBANT ACETATE 10 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Icatibant — NDC 55150-0351-03," retrieved September 3, 2026, https://drugdashboards.com/drug/55150035103.

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