Data / Drug companies / Bicalutamide
Bicalutamide: 9 companies and 10 products in the FDA NDC directory
Bicalutamide is listed in the FDA National Drug Code Directory by 9 companies, with 10 products in commercial distribution. 7 of the products (70.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet; tablet, film coated, and the newest product started marketing on October 26, 2020.
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- Companies listing it
- 9
- Products
- 10
- Generic (ANDA) products
- 7 (70.0%)
- Application numbers
- 4
- Routes
- Oral
- Brand names
- Casodex
- openFDA record search
- api.fda.gov
Companies that list bicalutamide
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Ani Pharmaceuticals, Inc. | 2 | tablet | New drug applications (NDA) | October 26, 2020 |
| Accord Healthcare Inc. | 1 | tablet | Generic drugs (ANDA) | July 6, 2009 |
| Bryant Ranch Prepack | 1 | tablet | Generic drugs (ANDA) | July 6, 2009 |
| Golden State Medical Supply, Inc. | 1 | tablet | New drug applications (NDA) | October 4, 1995 |
| Pinnacle Life Science Private Limited | 1 | tablet | Generic drugs (ANDA) | June 7, 2009 |
| Proficient Rx LP | 1 | tablet | Generic drugs (ANDA) | July 6, 2009 |
| Proficient Rx LP | 1 | tablet, film coated | Generic drugs (ANDA) | December 15, 2014 |
| Sun Pharmaceutical Industries, Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | December 15, 2014 |
| Viona Pharmaceuticals Inc | 1 | tablet | Generic drugs (ANDA) | June 7, 2009 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 8 | 80% |
| Tablet, film coated | 2 | 20% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 7 | 70% |
| New drug applications (NDA) | 3 | 30% |
Pharmacologic classes
| Class | Products |
|---|---|
| Androgen Receptor Inhibitor | 10 |
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.