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.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Medical Purchasing Solutions, LLC | 5 | injection, solution | Generic drugs (ANDA) | October 31, 2024 |
| Remedyrepack Inc. | 4 | tablet; injection, solution | Generic drugs (ANDA) | June 14, 2022 |
| Sun Pharmaceutical Industries, Inc. | 4 | tablet | Generic drugs (ANDA) | December 2, 2003 |
| Advagen Pharma Ltd | 3 | tablet | Generic drugs (ANDA) | August 21, 2020 |
| Bryant Ranch Prepack | 3 | tablet | Generic drugs (ANDA) | September 1, 2020 |
| Chartwell RX, LLC | 3 | tablet | Generic drugs (ANDA) | January 1, 2017 |
| Eugia US LLC | 3 | injection, solution | Generic drugs (ANDA) | October 25, 2017 |
| Upsher-Smith Laboratories, LLC | 3 | tablet | Generic drugs (ANDA) | July 2, 2020 |
| Zhejiang Poly Pharm. Co., Ltd. | 3 | injection, solution | Generic drugs (ANDA) | February 6, 2023 |
| Zydus Lifesciences Limited | 3 | tablet | Generic drugs (ANDA) | February 9, 2023 |
| Zydus Pharmaceuticals USA Inc. | 3 | tablet | Generic drugs (ANDA) | February 9, 2023 |
| A-S Medication Solutions | 2 | tablet | Generic drugs (ANDA) | September 1, 2020 |
| Baxter Healthcare Corporation | 2 | injection, solution | New drug applications (NDA) | November 16, 2010 |
| Cardinal Health 107, LLC | 2 | tablet | Generic drugs (ANDA) | June 15, 2019 |
| Dr. Reddy's Laboratories Inc. | 2 | tablet | Generic drugs (ANDA) | March 15, 2024 |
| Fresenius Kabi USA, LLC | 2 | injection, solution | Generic drugs (ANDA) | May 5, 2025 |
| HF Acquisition Co LLC, DBA HealthFirst | 2 | injection, solution | Generic drugs (ANDA) | July 6, 2019 |
| Major Pharmaceuticals | 2 | tablet | Generic drugs (ANDA) | May 12, 2026 |
| NCS HealthCare of Ky, LLC DBA Vangard Labs | 2 | tablet | Generic drugs (ANDA) | August 21, 2020 |
| American Health Packaging | 1 | tablet | Generic drugs (ANDA) | September 30, 2019 |
| Aphena Pharma Solutions - Tennessee, LLC | 1 | tablet | Generic drugs (ANDA) | November 15, 2010 |
| Aurobindo Pharma Limited | 1 | tablet | Generic drugs (ANDA) | June 3, 2016 |
| AvPAK | 1 | tablet | Generic drugs (ANDA) | September 11, 2019 |
| Bryant Ranch Prepack | 1 | tablet | Generic drugs (ANDA) | November 15, 2010 |
| Fresenius Kabi USA, LLC | 1 | injection, solution | Generic drugs (ANDA) | January 28, 2003 |
| Gland Pharma Limited | 1 | injection, solution | Generic drugs (ANDA) | July 15, 2013 |
| Henry Schein, Inc. | 1 | injection, solution | Generic drugs (ANDA) | October 29, 2025 |
| Hikma Pharmaceuticals USA Inc. | 1 | injection, solution | Generic drugs (ANDA) | February 25, 2008 |
| Mylan Institutional LLC | 1 | injection, solution | Generic drugs (ANDA) | October 14, 2002 |
| Mylan Institutional LLC | 1 | injection, solution | Generic drugs (ANDA) | June 9, 2023 |
| ProPharma Distribution | 1 | injection, solution | Generic drugs (ANDA) | October 14, 2002 |
| Redpharm Drug | 1 | tablet | Generic drugs (ANDA) | September 1, 2020 |
| Safecor Health, LLC | 1 | tablet | Generic drugs (ANDA) | June 1, 2026 |
| Slate Run Pharmaceuticals, LLC | 1 | injection, solution | Generic drugs (ANDA) | October 31, 2024 |
| Unichem Pharmaceuticals (USA), Inc. | 1 | tablet | Generic drugs (ANDA) | September 1, 2020 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 43 | 62.3% |
| Injection, solution | 26 | 37.7% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 67 | 97.1% |
| New drug applications (NDA) | 2 | 2.9% |
Pharmacologic classes
| Class | Products |
|---|---|
| Antiarrhythmic | 69 |
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.