Data / Drug companies / Mirtazapine
Mirtazapine: 42 companies and 144 products in the FDA NDC directory
Mirtazapine is listed in the FDA National Drug Code Directory by 42 companies, with 144 products in commercial distribution. 139 of the products (96.5%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; tablet, orally disintegrating; tablet, and the newest product started marketing on August 21, 2026.
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- Companies listing it
- 42
- Products
- 144
- Generic (ANDA) products
- 139 (96.5%)
- Application numbers
- 11
- Routes
- Oral
- Brand names
- Remeronsoltab, Remeron
- openFDA record search
- api.fda.gov
Companies that list mirtazapine
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Bryant Ranch Prepack | 11 | tablet, film coated; tablet | Generic drugs (ANDA) | August 7, 2022 |
| Remedyrepack Inc. | 9 | tablet, film coated; tablet | Generic drugs (ANDA) | January 18, 2026 |
| Aphena Pharma Solutions - Tennessee, LLC | 8 | tablet, film coated; tablet | Generic drugs (ANDA) | September 1, 2023 |
| Aurobindo Pharma Limited | 7 | tablet, film coated; tablet, orally disintegrating | Generic drugs (ANDA) | February 28, 2006 |
| Rising Pharma Holdings, Inc. | 7 | tablet, film coated; tablet, orally disintegrating | Generic drugs (ANDA) | February 28, 2006 |
| Coupler LLC | 6 | tablet, film coated | Generic drugs (ANDA) | August 21, 2026 |
| A-S Medication Solutions | 5 | tablet, film coated | Generic drugs (ANDA) | October 2, 2025 |
| Bryant Ranch Prepack | 5 | tablet; tablet, film coated | Generic drugs (ANDA) | August 17, 2009 |
| Organon LLC | 5 | tablet, orally disintegrating; tablet, film coated | New drug applications (NDA) | June 1, 2021 |
| Aurolife Pharma, LLC | 4 | tablet, film coated | Generic drugs (ANDA) | August 17, 2009 |
| Camber Pharmaceuticals, Inc. | 4 | tablet, film coated | Generic drugs (ANDA) | October 2, 2025 |
| Cardinal Health 107, LLC | 4 | tablet, film coated; tablet, orally disintegrating | Generic drugs (ANDA) | July 10, 2026 |
| NCS HealthCare of Ky, LLC DBA Vangard Labs | 4 | tablet, film coated | Generic drugs (ANDA) | May 14, 2026 |
| Prasco Laboratories | 4 | tablet, film coated | Generic drugs (ANDA) | September 1, 2023 |
| Proficient Rx LP | 4 | tablet, film coated | Generic drugs (ANDA) | August 17, 2009 |
| Sun Pharmaceutical Industries, Inc. | 4 | tablet | Generic drugs (ANDA) | April 22, 2004 |
| XLCare Pharmaceuticals, Inc. | 4 | tablet, film coated | Generic drugs (ANDA) | October 2, 2025 |
| American Health Packaging | 3 | tablet, film coated | Generic drugs (ANDA) | January 5, 2006 |
| Apotex Corp. | 3 | tablet, film coated | Generic drugs (ANDA) | August 22, 2007 |
| Bryant Ranch Prepack | 3 | tablet; tablet, film coated | Generic drugs (ANDA) | August 17, 2009 |
| Golden State Medical Supply, Inc. | 3 | tablet, film coated | Generic drugs (ANDA) | June 19, 2003 |
| Mylan Institutional Inc. | 3 | tablet, film coated | Generic drugs (ANDA) | August 1, 2003 |
| Mylan Pharmaceuticals Inc. | 3 | tablet, film coated | Generic drugs (ANDA) | June 20, 2003 |
| NuCare Pharmaceuticals,Inc. | 3 | tablet, film coated | Generic drugs (ANDA) | October 22, 2004 |
| Preferred Pharmaceuticals Inc. | 3 | tablet, film coated | Generic drugs (ANDA) | June 14, 2023 |
| Safecor Health, LLC | 3 | tablet, film coated | Generic drugs (ANDA) | February 5, 2026 |
| Square Pharmaceuticals Limited | 3 | tablet, orally disintegrating | Generic drugs (ANDA) | November 15, 2022 |
| Viona Pharmaceuticals Inc | 3 | tablet, orally disintegrating | Generic drugs (ANDA) | August 7, 2022 |
| AvKARE | 2 | tablet; tablet, film coated | Generic drugs (ANDA) | May 20, 2025 |
| McKesson Corporation DBA Sky Packaging | 2 | tablet, film coated | Generic drugs (ANDA) | August 22, 2007 |
| Advanced Rx of Tennessee, LLC | 1 | tablet, film coated | Generic drugs (ANDA) | April 7, 2023 |
| American Health Packaging | 1 | tablet, film coated | Generic drugs (ANDA) | August 29, 2022 |
| Ani Pharmaceuticals, Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | May 14, 2026 |
| Aphena Pharma Solutions - Tennessee, LLC | 1 | tablet, film coated | Generic drugs (ANDA) | August 22, 2007 |
| Atlantic Biologicals Corp. | 1 | tablet, film coated | Generic drugs (ANDA) | August 17, 2009 |
| Direct RX | 1 | tablet, film coated | Generic drugs (ANDA) | May 10, 2022 |
| Direct_Rx | 1 | tablet, film coated | Generic drugs (ANDA) | June 2, 2025 |
| Major Pharmaceuticals | 1 | tablet, film coated | Generic drugs (ANDA) | August 22, 2007 |
| NorthStar RxLLC | 1 | tablet, film coated | Generic drugs (ANDA) | April 1, 2025 |
| Proficient Rx LP | 1 | tablet, film coated | Generic drugs (ANDA) | October 22, 2004 |
| Redpharm Drug | 1 | tablet, film coated | Generic drugs (ANDA) | April 1, 2025 |
| Unit Dose Solutions, Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | August 17, 2009 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 111 | 77.1% |
| Tablet, orally disintegrating | 18 | 12.5% |
| Tablet | 15 | 10.4% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 139 | 96.5% |
| New drug applications (NDA) | 5 | 3.5% |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). 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.