DrugDashboards

Amiodarone Hydrochloride

amiodarone hydrochloride · AMIODARONE HYDROCHLORIDE 50 mg/mL · Injection, Solution · Intravenous · Mylan Institutional LLC

NDC 67457-0153-03 · 10 VIAL, GLASS in 1 CARTON / 3 mL in 1 VIAL, GLASS · ANDA · View full market →

The short version

14 companies supply this market — deep enough that no single failure threatens the supply. 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.

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

  • Medicare Part B pays (ASP+6%)$0.4000per billing unit (30 MG)HCPCS J0282 · Jul 1, 2026
  • Federal contracts pay (FSS)$34.33per package of 10X3MLMylan Institutional LLC · Nov 15, 2023

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
$44.02
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 30 MG
$0.400
HCPCS J0282 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2024)

$40
12 prescriptions paid by Medicaid nationally · all Medicaid spend →

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 →

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
ANDA076217
TE code
AP
Approval date
Oct 15, 2002
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class I · TerminatedAug 17, 2020
    Mylan Institutional LLC — Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
  • Class II · TerminatedSep 12, 2014
    Mckesson — Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical Inc., one of the distributing wholesalers.

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 67457-0153-03," retrieved September 3, 2026, https://drugdashboards.com/drug/67457015303.

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