Data / Drug companies / Quetiapine
Quetiapine: 30 companies and 153 products in the FDA NDC directory
Quetiapine is listed in the FDA National Drug Code Directory by 30 companies, with 153 products in commercial distribution. 133 of the products (86.9%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; tablet, film coated, extended release; tablet, extended release, and the newest product started marketing on October 8, 2026.
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- Companies listing it
- 30
- Products
- 153
- Generic (ANDA) products
- 133 (86.9%)
- Application numbers
- 14
- Routes
- Oral
- Brand names
- Seroquel, Seroquel XR
- openFDA record search
- api.fda.gov
Companies that list quetiapine
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| BluePoint Laboratories | 11 | tablet; tablet, extended release | Generic drugs (ANDA) | November 1, 2023 |
| H2-Pharma, LLC | 11 | tablet, film coated; tablet, extended release | New drug applications (NDA) | February 1, 2009 |
| Major Pharmaceuticals | 11 | tablet, film coated; tablet, film coated, extended release | Generic drugs (ANDA) | August 22, 2017 |
| Solco Healthcare US, LLC | 11 | tablet; tablet, extended release | Generic drugs (ANDA) | April 12, 2022 |
| AstraZeneca Pharmaceuticals LP | 9 | tablet, film coated; tablet, extended release | New drug applications (NDA) | February 1, 2009 |
| Ascend Laboratories, LLC | 7 | tablet, film coated | Generic drugs (ANDA) | March 1, 2013 |
| Asclemed USA, Inc. | 7 | tablet, film coated | Generic drugs (ANDA) | March 1, 2013 |
| Remedyrepack Inc. | 7 | tablet, extended release; tablet, film coated, extended release | Generic drugs (ANDA) | October 8, 2026 |
| Accord Healthcare Inc. | 6 | tablet, film coated | Generic drugs (ANDA) | March 28, 2012 |
| American Health Packaging | 6 | tablet | Generic drugs (ANDA) | June 27, 2018 |
| Coupler LLC | 6 | tablet; tablet, film coated | Generic drugs (ANDA) | July 10, 2026 |
| Teva Pharmaceuticals USA, Inc. | 6 | tablet, film coated | Generic drugs (ANDA) | March 12, 2014 |
| Aci Healthcare USA, Inc. | 5 | tablet, film coated, extended release | Generic drugs (ANDA) | November 29, 2017 |
| Aurobindo Pharma Limited | 5 | tablet, film coated, extended release | Generic drugs (ANDA) | November 29, 2017 |
| Golden State Medical Supply, Inc. | 5 | tablet, film coated, extended release | Generic drugs (ANDA) | November 16, 2018 |
| Lupin Pharmaceuticals, Inc. | 5 | tablet, film coated, extended release | Generic drugs (ANDA) | August 22, 2017 |
| ScieGen Pharmaceuticals, Inc. | 5 | tablet, film coated, extended release | Generic drugs (ANDA) | November 29, 2017 |
| Unichem Pharmaceuticals (USA), Inc. | 5 | tablet, extended release | Generic drugs (ANDA) | August 15, 2022 |
| Cardinal Health 107, LLC | 4 | tablet, film coated | Generic drugs (ANDA) | March 1, 2013 |
| Macleods Pharmaceuticals Limited | 4 | tablet, extended release | Generic drugs (ANDA) | November 1, 2017 |
| Proficient Rx LP | 3 | tablet, film coated | Generic drugs (ANDA) | March 28, 2012 |
| Unit Dose Solutions, Inc. | 3 | tablet | Generic drugs (ANDA) | July 6, 2026 |
| AlignScience Pharma Inc. | 2 | tablet, film coated, extended release | Generic drugs (ANDA) | December 31, 2020 |
| Bryant Ranch Prepack | 2 | tablet, film coated; tablet, extended release | Generic drugs (ANDA) | November 1, 2017 |
| Bryant Ranch Prepack | 2 | tablet, film coated; tablet, extended release | Generic drugs (ANDA) | August 15, 2022 |
| A-S Medication Solutions | 1 | tablet, film coated | Generic drugs (ANDA) | March 1, 2013 |
| Aphena Pharma Solutions - Tennessee, LLC | 1 | tablet, film coated | Generic drugs (ANDA) | May 25, 2022 |
| NuCare Pharmaceuticals,Inc. | 1 | tablet, film coated, extended release | Generic drugs (ANDA) | November 29, 2017 |
| PD-Rx Pharmaceuticals, Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | March 1, 2013 |
| St. Mary's Medical Park Pharmacy | 1 | tablet, film coated, extended release | Generic drugs (ANDA) | November 29, 2017 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 57 | 37.3% |
| Tablet, film coated, extended release | 36 | 23.5% |
| Tablet, extended release | 35 | 22.9% |
| Tablet | 25 | 16.3% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 133 | 86.9% |
| New drug applications (NDA) | 20 | 13.1% |
Pharmacologic classes
| Class | Products |
|---|---|
| Atypical Antipsychotic | 153 |
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.