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Data / Drug companies / Amiodarone hydrochloride

Amiodarone hydrochloride: 35 companies and 69 products in the FDA NDC directory

Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).

Amiodarone hydrochloride is listed in the FDA National Drug Code Directory by 35 companies, with 69 products in commercial distribution. 67 of the products (97.1%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet; injection, solution, and the newest product started marketing on June 1, 2026.

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Companies listing it
35
Products
69
Generic (ANDA) products
67 (97.1%)
Application numbers
16
Routes
Oral, Intravenous
Brand names
Pacerone, Nexterone
openFDA record search
api.fda.gov

Companies that list amiodarone hydrochloride

Ranked by number of products. Finished drugs in commercial distribution.

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Medical Purchasing Solutions, LLC5injection, solutionGeneric drugs (ANDA)October 31, 2024
Remedyrepack Inc.4tablet; injection, solutionGeneric drugs (ANDA)June 14, 2022
Sun Pharmaceutical Industries, Inc.4tabletGeneric drugs (ANDA)December 2, 2003
Advagen Pharma Ltd3tabletGeneric drugs (ANDA)August 21, 2020
Bryant Ranch Prepack3tabletGeneric drugs (ANDA)September 1, 2020
Chartwell RX, LLC3tabletGeneric drugs (ANDA)January 1, 2017
Eugia US LLC3injection, solutionGeneric drugs (ANDA)October 25, 2017
Upsher-Smith Laboratories, LLC3tabletGeneric drugs (ANDA)July 2, 2020
Zhejiang Poly Pharm. Co., Ltd.3injection, solutionGeneric drugs (ANDA)February 6, 2023
Zydus Lifesciences Limited3tabletGeneric drugs (ANDA)February 9, 2023
Zydus Pharmaceuticals USA Inc.3tabletGeneric drugs (ANDA)February 9, 2023
A-S Medication Solutions2tabletGeneric drugs (ANDA)September 1, 2020
Baxter Healthcare Corporation2injection, solutionNew drug applications (NDA)November 16, 2010
Cardinal Health 107, LLC2tabletGeneric drugs (ANDA)June 15, 2019
Dr. Reddy's Laboratories Inc.2tabletGeneric drugs (ANDA)March 15, 2024
Fresenius Kabi USA, LLC2injection, solutionGeneric drugs (ANDA)May 5, 2025
HF Acquisition Co LLC, DBA HealthFirst2injection, solutionGeneric drugs (ANDA)July 6, 2019
Major Pharmaceuticals2tabletGeneric drugs (ANDA)May 12, 2026
NCS HealthCare of Ky, LLC DBA Vangard Labs2tabletGeneric drugs (ANDA)August 21, 2020
American Health Packaging1tabletGeneric drugs (ANDA)September 30, 2019
Aphena Pharma Solutions - Tennessee, LLC1tabletGeneric drugs (ANDA)November 15, 2010
Aurobindo Pharma Limited1tabletGeneric drugs (ANDA)June 3, 2016
AvPAK1tabletGeneric drugs (ANDA)September 11, 2019
Bryant Ranch Prepack1tabletGeneric drugs (ANDA)November 15, 2010
Fresenius Kabi USA, LLC1injection, solutionGeneric drugs (ANDA)January 28, 2003
Gland Pharma Limited1injection, solutionGeneric drugs (ANDA)July 15, 2013
Henry Schein, Inc.1injection, solutionGeneric drugs (ANDA)October 29, 2025
Hikma Pharmaceuticals USA Inc.1injection, solutionGeneric drugs (ANDA)February 25, 2008
Mylan Institutional LLC1injection, solutionGeneric drugs (ANDA)October 14, 2002
Mylan Institutional LLC1injection, solutionGeneric drugs (ANDA)June 9, 2023
ProPharma Distribution1injection, solutionGeneric drugs (ANDA)October 14, 2002
Redpharm Drug1tabletGeneric drugs (ANDA)September 1, 2020
Safecor Health, LLC1tabletGeneric drugs (ANDA)June 1, 2026
Slate Run Pharmaceuticals, LLC1injection, solutionGeneric drugs (ANDA)October 31, 2024
Unichem Pharmaceuticals (USA), Inc.1tabletGeneric drugs (ANDA)September 1, 2020

Dosage forms

Dosage formProductsShare
Tablet4362.3%
Injection, solution2637.7%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)6797.1%
New drug applications (NDA)22.9%

Pharmacologic classes

ClassProducts
Antiarrhythmic69

CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.