Quick answers
- What is Amiodarone hydrochloride used for?
- The FDA-approved label (Nexterone, Baxter Healthcare Corporation, April 16, 2024) says: “NEXTERONE is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Amiodarone hydrochloride have a boxed warning?
- The label we quote has no boxed warning, but 28 of 50 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Amiodarone hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Amiodarone hydrochloride been recalled?
- FDA enforcement reports list 7 recalls of products of this medicine; the newest started August 6, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Amiodarone hydrochloride?
- 32 companies list prescription products of Amiodarone hydrochloride in the FDA NDC Directory, including Medical Purchasing Solutions, LLC, HF Acquisition Co LLC, DBA HealthFirst and Sun Pharmaceutical Industries, Inc..
What Amiodarone hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
NEXTERONE is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. …
— FDA label: Nexterone, Baxter Healthcare Corporation, effective April 16, 2024. Read the full label on DailyMed →
The FDA has 50 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
28 of 50 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| amiodarone hydrochloride 100 mg tablet | Generic | $0.3670 per tablet |
| amiodarone hydrochloride 100 mg tablet | Brand: Pacerone | $0.7762 per tablet |
| amiodarone hydrochloride 200 mg tablet | Generic | $0.1211 per tablet |
| amiodarone hydrochloride 200 mg tablet | Brand: Pacerone | $0.1249 per tablet |
| amiodarone hydrochloride 400 mg tablet | Generic | $0.6456 per tablet |
| amiodarone hydrochloride 50 mg/mL injection, solution | Generic | $0.5212 per mL |
NADAC list of November 4, 2026; these prices took effect between November 19, 2025 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Medical Purchasing Solutions, LLC5 products
- HF Acquisition Co LLC, DBA HealthFirst5 products
- Sun Pharmaceutical Industries, Inc.4 products
- Bryant Ranch Prepack4 products
- Remedyrepack Inc.4 products
- AuroMedics Pharma LLC3 products
- Advagen Pharma Limited3 products
- Fresenius Kabi USA, LLC3 products
- Zydus Lifesciences Limited3 products
- Zydus Pharmaceuticals USA Inc.3 products
- Upsher-Smith Laboratories, LLC3 products
- Zhejiang Poly Pharm. Co., Ltd.3 products
- Chartwell RX, LLC3 products
- Mylan Institutional LLC2 products
- NCS HealthCare of KY, LLC dba Vangard Labs2 products
- Dr. Reddy's Labratories Inc.2 products
- Baxter Healthcare Corporation2 products
- Cardinal Health 107, LLC2 products
- Major Pharmaceuticals2 products
- A-S Medication Solutions2 products
- Unichem Pharmaceuticals (USA), Inc.1 product
- Henry Schein, Inc.1 product
- Gland Pharma Limited1 product
- Redpharm Drug1 product
- ProPharma Distribution1 product
- Safecor Health LLC1 product
- American Health Packaging1 product
- Aurobindo Pharma Limited1 product
- Aphena Pharma Solutions - Tennessee, LLC1 product
- Hikma Pharmaceuticals USA Inc.1 product
- AvPAK1 product
- Slate Run Pharmaceuticals1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022325 NEXTERONE | Baxter Hlthcare | December 24, 2008 | 14, latest February 21, 2025 2025: Labeling · 2021: Labeling · 2017: Labeling |
Generic approvals (15)
- ANDA075135Upsher Smith Labs · April 30, 1998
- ANDA075389DR Reddys Labs SA · January 25, 2001
- ANDA075424Taro · March 30, 2001
- ANDA075761Fresenius Kabi USA · October 15, 2002
- ANDA076217Mylan Institutional · October 15, 2002
- ANDA076362Taro · November 29, 2002
- ANDA077069Chartwell Rx · April 8, 2005
- ANDA077161Gland Pharma Ltd · April 20, 2005
- ANDA077234Hikma Farmaceutica · February 25, 2008
- ANDA079029Zydus Pharms USA Inc · September 16, 2008
- ANDA078578Rubicon Research · November 6, 2008
- ANDA204742Aurobindo Pharma Ltd · June 3, 2016
- ANDA204550Eugia Pharma · October 25, 2017
- ANDA213446Unichem · July 21, 2020
- ANDA218253Zhejiang Poly Pharm · September 11, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
August 6, 2026 · Class II · Ongoing · D-0814-2026
CGMP Deviations
Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in the USA, NDC 430 — Baxter Healthcare Corporation
-
August 17, 2020 · Class I · Terminated · D-1575-2020
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.
Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial (NDC 67457-153-99); 10 x 9 mL Single-Dose Vials per carton (NDC 67457-153-09), Rx only, Manufactured by: Mylan Institutional, Galway, — Mylan Institutional LLC
-
November 11, 2019 · Class III · Terminated · D-0521-2020
Crystallization: Presence of visible particulate matter.
Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-181-09 — AuroMedics Pharma LLC
-
November 11, 2019 · Class III · Terminated · D-0520-2020
Crystallization: Presence of visible particulate matter.
Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-180-03 — AuroMedics Pharma LLC
-
November 11, 2019 · Class III · Terminated · D-0522-2020
Crystallization: Presence of visible particulate matter.
Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-182-18 — AuroMedics Pharma LLC
-
November 10, 2017 · Class I · Terminated · D-0573-2018
Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged
Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10 — Baxter Healthcare Corporation
-
September 12, 2014 · Class II · Terminated · D-0005-2015
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.
Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, Rx only, Manufactured for Mylan Institutional, LLC, Rockford, IL 61103, NDC 67457-153-09. — Mckesson
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Nexterone, Baxter Healthcare Corporation, effective April 16, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →