Data / Drug companies / Clozapine
Clozapine: 13 companies and 48 products in the FDA NDC directory
Clozapine is listed in the FDA National Drug Code Directory by 13 companies, with 48 products in commercial distribution. 45 of the products (93.8%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet; tablet, orally disintegrating; suspension, and the newest product started marketing on August 1, 2026.
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- Companies listing it
- 13
- Products
- 48
- Generic (ANDA) products
- 45 (93.8%)
- Application numbers
- 8
- Routes
- Oral
- Brand names
- Clozaril, Versacloz
- openFDA record search
- api.fda.gov
Companies that list clozapine
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Mylan Pharmaceuticals Inc. | 8 | tablet, orally disintegrating; tablet | Generic drugs (ANDA) | August 16, 2023 |
| Aurobindo Pharma Limited | 5 | tablet, orally disintegrating | Generic drugs (ANDA) | December 12, 2024 |
| Teva Pharmaceuticals USA, Inc. | 5 | tablet, orally disintegrating | Generic drugs (ANDA) | July 30, 2020 |
| American Health Packaging | 4 | tablet | Generic drugs (ANDA) | July 7, 2020 |
| Aurobindo Pharma Limited | 4 | tablet | Generic drugs (ANDA) | November 29, 2016 |
| Major Pharmaceuticals | 4 | tablet | Generic drugs (ANDA) | November 29, 2016 |
| Mylan Institutional Inc. | 4 | tablet; tablet, orally disintegrating | Generic drugs (ANDA) | September 26, 2016 |
| NorthStar RxLLC | 4 | tablet | Generic drugs (ANDA) | August 1, 2026 |
| Safecor Health, LLC | 4 | tablet; tablet, orally disintegrating | Generic drugs (ANDA) | March 5, 2026 |
| Accord Healthcare Inc. | 2 | tablet | Generic drugs (ANDA) | April 10, 2017 |
| HLS Therapeutics (USA), Inc. | 2 | tablet | New drug applications (NDA) | May 6, 2016 |
| Cardinal Health 107, LLC | 1 | tablet | Generic drugs (ANDA) | November 29, 2016 |
| TruPharma, LLC | 1 | suspension | New drug applications (NDA) | June 15, 2018 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 31 | 64.6% |
| Tablet, orally disintegrating | 16 | 33.3% |
| Suspension | 1 | 2.1% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 45 | 93.8% |
| New drug applications (NDA) | 3 | 6.2% |
Pharmacologic classes
| Class | Products |
|---|---|
| Atypical Antipsychotic | 48 |
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.