Data / Drug companies / Temozolomide
Temozolomide: 12 companies and 73 products in the FDA NDC directory
Temozolomide is listed in the FDA National Drug Code Directory by 12 companies, with 73 products in commercial distribution. 66 of the products (90.4%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are capsule; injection, powder, lyophilized, for solution, and the newest product started marketing on October 31, 2026.
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- Companies listing it
- 12
- Products
- 73
- Generic (ANDA) products
- 66 (90.4%)
- Application numbers
- 10
- Routes
- Oral, Intravenous
- Brand names
- Temodar
- openFDA record search
- api.fda.gov
Companies that list temozolomide
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Merck Sharp & Dohme LLC | 7 | capsule; injection, powder, lyophilized, for solution | New drug applications (NDA) | February 27, 2009 |
| Accord Healthcare Inc. | 6 | capsule | Generic drugs (ANDA) | March 7, 2017 |
| Amneal Pharmaceuticals LLC | 6 | capsule | Generic drugs (ANDA) | April 3, 2015 |
| Ascend Laboratories, LLC | 6 | capsule | Generic drugs (ANDA) | April 28, 2017 |
| Bryant Ranch Prepack | 6 | capsule | Generic drugs (ANDA) | April 28, 2017 |
| Camber Pharmaceuticals, Inc. | 6 | capsule | Generic drugs (ANDA) | August 23, 2024 |
| CivicaScript LLC | 6 | capsule | Generic drugs (ANDA) | August 10, 2026 |
| Devatis, Inc. | 6 | capsule | Generic drugs (ANDA) | April 28, 2017 |
| Nivagen Pharmaceuticals, Inc. | 6 | capsule | Generic drugs (ANDA) | December 7, 2021 |
| Opko Pharmaceuticals, LLC | 6 | capsule | Generic drugs (ANDA) | October 31, 2026 |
| Rising Pharma Holdings, Inc. | 6 | capsule | Generic drugs (ANDA) | October 4, 2022 |
| Sun Pharmaceutical Industries, Inc. | 6 | capsule | Generic drugs (ANDA) | February 13, 2014 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Capsule | 72 | 98.6% |
| Injection, powder, lyophilized, for solution | 1 | 1.4% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 66 | 90.4% |
| New drug applications (NDA) | 7 | 9.6% |
Pharmacologic classes
| Class | Products |
|---|---|
| Alkylating Drug | 73 |
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.