Data / Drug companies / Mexiletine hydrochloride
Mexiletine hydrochloride: 16 companies and 50 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Mexiletine hydrochloride is listed in the FDA National Drug Code Directory by 16 companies, with 50 products in commercial distribution. 50 of the products (100.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are capsule, and the newest product started marketing on August 6, 2026.
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- Companies listing it
- 16
- Products
- 50
- Generic (ANDA) products
- 50 (100.0%)
- Application numbers
- 9
- Routes
- Oral
- openFDA record search
- api.fda.gov
Companies that list mexiletine hydrochloride
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Bryant Ranch Prepack | 6 | capsule | Generic drugs (ANDA) | November 29, 2021 |
| Bryant Ranch Prepack | 6 | capsule | Generic drugs (ANDA) | November 29, 2021 |
| Amerisyn LLC | 3 | capsule | Generic drugs (ANDA) | August 6, 2026 |
| Ani Pharmaceuticals, Inc. | 3 | capsule | Generic drugs (ANDA) | June 22, 2020 |
| AvKARE | 3 | capsule | Generic drugs (ANDA) | July 9, 2013 |
| Bryant Ranch Prepack | 3 | capsule | Generic drugs (ANDA) | February 5, 2025 |
| Camber Pharmaceuticals, Inc. | 3 | capsule | Generic drugs (ANDA) | November 9, 2022 |
| Golden State Medical Supply, Inc. | 3 | capsule | Generic drugs (ANDA) | May 16, 1996 |
| Ingenus Pharmaceuticals, LLC | 3 | capsule | Generic drugs (ANDA) | January 26, 2021 |
| Macleods Pharmaceuticals Limited | 3 | capsule | Generic drugs (ANDA) | March 23, 2026 |
| Rising Pharma Holdings, Inc. | 3 | capsule | Generic drugs (ANDA) | February 5, 2025 |
| Senores Pharmaceuticals, Inc. | 3 | capsule | Generic drugs (ANDA) | November 29, 2021 |
| Sun Pharmaceutical Industries, Inc. | 3 | capsule | Generic drugs (ANDA) | November 29, 2021 |
| Teva Pharmaceuticals USA, Inc. | 3 | capsule | Generic drugs (ANDA) | June 5, 1995 |
| American Health Packaging | 1 | capsule | Generic drugs (ANDA) | February 23, 2024 |
| Chartwell RX, LLC | 1 | capsule | Generic drugs (ANDA) | July 23, 2020 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Capsule | 50 | 100% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 50 | 100% |
Pharmacologic classes
| Class | Products |
|---|---|
| Antiarrhythmic | 50 |
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.