Data / Drug companies / Entecavir
Entecavir: 15 companies and 29 products in the FDA NDC directory
Entecavir is listed in the FDA National Drug Code Directory by 15 companies, with 29 products in commercial distribution. 26 of the products (89.7%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; tablet; solution, and the newest product started marketing on July 1, 2023.
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- Companies listing it
- 15
- Products
- 29
- Generic (ANDA) products
- 26 (89.7%)
- Application numbers
- 12
- Routes
- Oral
- Brand names
- Baraclude
- openFDA record search
- api.fda.gov
Companies that list entecavir
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Epic Pharma, LLC | 4 | tablet; tablet, film coated | Generic drugs (ANDA) | October 31, 2022 |
| E.r. Squibb & Sons, L.L.C. | 3 | tablet, film coated; solution | New drug applications (NDA) | March 29, 2005 |
| Amneal Pharmaceuticals LLC | 2 | tablet, film coated | Generic drugs (ANDA) | November 28, 2014 |
| Aurobindo Pharma Limited | 2 | tablet | Generic drugs (ANDA) | August 26, 2015 |
| Camber Pharmaceuticals, Inc. | 2 | tablet | Generic drugs (ANDA) | August 21, 2015 |
| Cipla USA Inc. | 2 | tablet, film coated | Generic drugs (ANDA) | December 6, 2016 |
| NorthStar Rx LLC | 2 | tablet, film coated | Generic drugs (ANDA) | June 15, 2017 |
| Solco Healthcare US, LLC | 2 | tablet, film coated | Generic drugs (ANDA) | April 1, 2018 |
| Yaopharma Co., Ltd. | 2 | tablet, film coated | Generic drugs (ANDA) | July 1, 2023 |
| Zydus Lifesciences Limited | 2 | tablet, film coated | Generic drugs (ANDA) | August 10, 2017 |
| Zydus Pharmaceuticals USA Inc. | 2 | tablet, film coated | Generic drugs (ANDA) | August 10, 2017 |
| American Health Packaging | 1 | tablet | Generic drugs (ANDA) | August 12, 2016 |
| AvKARE | 1 | tablet, film coated | Generic drugs (ANDA) | November 2, 2020 |
| Carlsbad Technology, Inc. | 1 | tablet | Generic drugs (ANDA) | November 10, 2021 |
| Golden State Medical Supply, Inc. | 1 | tablet | Generic drugs (ANDA) | November 10, 2021 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 19 | 65.5% |
| Tablet | 9 | 31% |
| Solution | 1 | 3.4% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 26 | 89.7% |
| New drug applications (NDA) | 3 | 10.3% |
Pharmacologic classes
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.