DrugDashboards

Amiodarone Hydrochloride

Amiodarone Hydrochloride · AMIODARONE HYDROCHLORIDE 450 mg/9mL · Injection, Solution · Intravenous · AuroMedics Pharma LLC

NDC 55150-0181-09 · 10 VIAL, SINGLE-DOSE in 1 CARTON / 9 mL in 1 VIAL, SINGLE-DOSE · ANDA · View full market →

The short version

14 companies supply this market — deep enough that no single failure threatens the supply. One of its named manufacturing plants, Eugia Pharma Specialities Limited, failed FDA inspectionwithin the last two years — the agency’s most serious outcome. Historically, drugs in this position went on to a new shortage within 90 days about 0.5% of the time — roughly 4× the typical drug (0.1%).

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
$45.00
Reported to Texas DSHS · 2024 annual filing · Auromedics Pharma Llc

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

Supply fragility

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

90-day shortage risk (model v2)

0.5%chance of a new FDA shortage posting for amiodarone hydrochloride (injectable) in the next 90 days

sterile injectable · OAI inspection at a producing facility (24 months) · sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is 4× that.

Backtested statistical model over the whole market, not this package alone. Model details →

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
ANDA204550
TE code
Approval date
Oct 25, 2017
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class III · TerminatedNov 11, 2019
    AuroMedics Pharma LLCCrystallization: Presence of visible particulate matter.
  • Class III · TerminatedNov 11, 2019
    AuroMedics Pharma LLCCrystallization: Presence of visible particulate matter.
  • Class III · TerminatedNov 11, 2019
    AuroMedics Pharma LLCCrystallization: Presence of visible particulate matter.

Manufacturers of Amiodarone Hydrochloride (Injection, Solution)

LabelerStrengthFirst seenLast seen
Fresenius Kabi USA, LLCAMIODARONE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 3, 2026
Medical Purchasing Solutions, LLCAMIODARONE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 3, 2026
Zhejiang Poly Pharm. Co., Ltd.AMIODARONE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 3, 2026
AuroMedics Pharma LLCAMIODARONE HYDROCHLORIDE 150 mg/3mLJul 15, 2026Sep 2, 2026
AuroMedics Pharma LLCAMIODARONE HYDROCHLORIDE 900 mg/18mLJul 15, 2026Sep 2, 2026
AuroMedics Pharma LLCAMIODARONE HYDROCHLORIDE 450 mg/9mLJul 15, 2026Sep 2, 2026
Baxter Healthcare CorporationAMIODARONE HYDROCHLORIDE 1.5 mg/mLJul 15, 2026Sep 2, 2026
Baxter Healthcare CorporationAMIODARONE HYDROCHLORIDE 1.8 mg/mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedAMIODARONE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 2, 2026
Henry Schein, Inc.AMIODARONE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 2, 2026
HF Acquisition Co LLC, DBA HealthFirstAMIODARONE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.AMIODARONE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 2, 2026
Medical Purchasing Solutions, LLCAMIODARONE HYDROCHLORIDE 150 mg/3mLJul 15, 2026Sep 2, 2026
Medical Purchasing Solutions, LLC.AMIODARONE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 2, 2026
ProPharma DistributionAMIODARONE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 2, 2026
Remedyrepack Inc.AMIODARONE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 2, 2026
Slate Run PharmaceuticalsAMIODARONE HYDROCHLORIDE 50 mg/mLJul 15, 2026Sep 2, 2026
Mylan Institutional LLCAMIODARONE HYDROCHLORIDE 50 mg/mLJul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Amiodarone Hydrochloride — NDC 55150-0181-09," retrieved September 3, 2026, https://drugdashboards.com/drug/55150018109.

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