Data / Drug companies / Quetiapine fumarate
Quetiapine fumarate: 33 companies and 190 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Quetiapine fumarate is listed in the FDA National Drug Code Directory by 33 companies, with 190 products in commercial distribution. 190 of the products (100.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; tablet; tablet, extended release, and the newest product started marketing on July 19, 2026.
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- Companies listing it
- 33
- Products
- 190
- Generic (ANDA) products
- 190 (100.0%)
- Application numbers
- 14
- Routes
- Oral
- openFDA record search
- api.fda.gov
Companies that list quetiapine fumarate
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Bryant Ranch Prepack | 20 | tablet, film coated; tablet | Generic drugs (ANDA) | July 1, 2016 |
| Remedyrepack Inc. | 13 | tablet, film coated; tablet | Generic drugs (ANDA) | July 19, 2026 |
| A-S Medication Solutions | 9 | tablet; tablet, film coated | Generic drugs (ANDA) | July 1, 2016 |
| Preferred Pharmaceuticals Inc. | 8 | tablet; tablet, film coated | Generic drugs (ANDA) | April 11, 2025 |
| Aurobindo Pharma Limited | 7 | tablet, film coated | Generic drugs (ANDA) | March 27, 2012 |
| Rising Pharma Holdings, Inc. | 7 | tablet, film coated | Generic drugs (ANDA) | March 27, 2012 |
| Alembic Pharmaceuticals Limited | 6 | tablet, film coated | Generic drugs (ANDA) | February 21, 2017 |
| AvPAK | 6 | tablet | Generic drugs (ANDA) | May 26, 2016 |
| Camber Pharmaceuticals, Inc. | 6 | tablet, film coated | Generic drugs (ANDA) | June 16, 2022 |
| Golden State Medical Supply, Inc. | 6 | tablet | Generic drugs (ANDA) | March 27, 2012 |
| Hikma Pharmaceuticals USA Inc. | 6 | tablet | Generic drugs (ANDA) | March 27, 2012 |
| Lupin Pharmaceuticals, Inc. | 6 | tablet | Generic drugs (ANDA) | March 27, 2012 |
| Macleods Pharmaceuticals Limited | 6 | tablet, film coated | Generic drugs (ANDA) | June 14, 2016 |
| NCS HealthCare of Ky, LLC DBA Vangard Labs | 6 | tablet, film coated | Generic drugs (ANDA) | July 1, 2016 |
| Sun Pharmaceutical Industries, Inc. | 6 | tablet, film coated | Generic drugs (ANDA) | March 28, 2012 |
| Unichem Pharmaceuticals (USA), Inc. | 6 | tablet, film coated | Generic drugs (ANDA) | July 1, 2016 |
| XLCare Pharmaceuticals, Inc. | 6 | tablet, film coated | Generic drugs (ANDA) | February 2, 2024 |
| Accord Healthcare Inc. | 5 | tablet, extended release | Generic drugs (ANDA) | January 1, 2019 |
| Aphena Pharma Solutions - Tennessee, LLC | 5 | tablet | Generic drugs (ANDA) | March 27, 2012 |
| Direct_Rx | 5 | tablet, film coated; tablet | Generic drugs (ANDA) | May 30, 2023 |
| Ingenus Pharmaceuticals, LLC | 5 | tablet, extended release | Generic drugs (ANDA) | August 31, 2017 |
| NorthStar Rx LLC | 5 | tablet, film coated | Generic drugs (ANDA) | March 27, 2012 |
| NuCare Pharmaceuticals,Inc. | 5 | tablet, film coated; tablet | Generic drugs (ANDA) | July 1, 2016 |
| Coupler LLC | 4 | tablet, film coated; tablet | Generic drugs (ANDA) | April 27, 2026 |
| Novast Laboratories, Ltd. | 4 | tablet, extended release | Generic drugs (ANDA) | August 31, 2017 |
| Quallent Pharmaceuticals Health LLC | 4 | tablet | Generic drugs (ANDA) | July 14, 2023 |
| Advanced Rx of Tennessee, LLC | 3 | tablet; tablet, film coated | Generic drugs (ANDA) | July 11, 2024 |
| Bryant Ranch Prepack | 3 | tablet, film coated | Generic drugs (ANDA) | March 28, 2012 |
| Proficient Rx LP | 3 | tablet | Generic drugs (ANDA) | March 1, 2013 |
| Proficient Rx LP | 3 | tablet, film coated | Generic drugs (ANDA) | March 26, 2012 |
| St. Mary's Medical Park Pharmacy | 3 | tablet; tablet, film coated | Generic drugs (ANDA) | May 21, 2025 |
| Proficient Rx LP | 2 | tablet; tablet, film coated | Generic drugs (ANDA) | March 1, 2013 |
| Unit Dose Solutions, Inc. | 1 | tablet | Generic drugs (ANDA) | July 6, 2026 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 110 | 57.9% |
| Tablet | 66 | 34.7% |
| Tablet, extended release | 14 | 7.4% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 190 | 100% |
Pharmacologic classes
| Class | Products |
|---|---|
| Atypical Antipsychotic | 190 |
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.