Data / Drug companies / Entacapone
Entacapone: 14 companies and 14 products in the FDA NDC directory
Entacapone is listed in the FDA National Drug Code Directory by 14 companies, with 14 products in commercial distribution. 11 of the products (78.6%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; tablet, and the newest product started marketing on April 23, 2026.
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- Companies listing it
- 14
- Products
- 14
- Generic (ANDA) products
- 11 (78.6%)
- Application numbers
- 6
- Routes
- Oral
- openFDA record search
- api.fda.gov
Companies that list entacapone
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Ajanta Pharma USA Inc. | 1 | tablet | Generic drugs (ANDA) | August 31, 2017 |
| Alembic Pharmaceuticals Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | January 6, 2022 |
| Alembic Pharmaceuticals Limited | 1 | tablet, film coated | Generic drugs (ANDA) | January 6, 2022 |
| American Health Packaging | 1 | tablet, film coated | Generic drugs (ANDA) | June 2, 2016 |
| Aphena Pharma Solutions - Tennessee, LLC | 1 | tablet, film coated | Authorized generics (NDA) | June 4, 2014 |
| Aurobindo Pharma Limited | 1 | tablet, film coated | Generic drugs (ANDA) | June 19, 2015 |
| AvPAK | 1 | tablet, film coated | Generic drugs (ANDA) | December 5, 2016 |
| Lannett Company, Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | December 20, 2018 |
| Macleods Pharmaceuticals Limited | 1 | tablet | Generic drugs (ANDA) | June 6, 2017 |
| Major Pharmaceuticals | 1 | tablet, film coated | Generic drugs (ANDA) | June 19, 2015 |
| NCS HealthCare of Ky, LLC DBA Vangard Labs | 1 | tablet | Generic drugs (ANDA) | June 6, 2017 |
| Rising Pharma Holdings, Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | April 23, 2026 |
| Sandoz Inc | 1 | tablet, film coated | Authorized generics (NDA) | June 4, 2014 |
| Sun Pharmaceutical Industries, Inc. | 1 | tablet, film coated | Authorized generics (NDA) | April 1, 2013 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 11 | 78.6% |
| Tablet | 3 | 21.4% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 11 | 78.6% |
| Authorized generics (NDA) | 3 | 21.4% |
Pharmacologic classes
| Class | Products |
|---|---|
| Catechol-O-Methyltransferase Inhibitor | 14 |
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.