Data / Drug companies / Varenicline
Varenicline: 11 companies and 28 products in the FDA NDC directory
Varenicline is listed in the FDA National Drug Code Directory by 11 companies, with 28 products in commercial distribution. 27 of the products (96.4%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; kit; tablet, and the newest product started marketing on January 9, 2026.
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- Companies listing it
- 11
- Products
- 28
- Generic (ANDA) products
- 27 (96.4%)
- Application numbers
- 7
- Routes
- Oral, Nasal
- Brand names
- Tyrvaya
- openFDA record search
- api.fda.gov
Companies that list varenicline
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Apotex Corp. | 5 | tablet, film coated; kit | Generic drugs (ANDA) | January 15, 2024 |
| A-S Medication Solutions | 4 | tablet, film coated | Generic drugs (ANDA) | December 10, 2024 |
| Aurobindo Pharma Limited | 3 | tablet, film coated; kit | Generic drugs (ANDA) | May 2, 2025 |
| Macleods Pharmaceuticals Limited | 3 | tablet, film coated; kit | Generic drugs (ANDA) | December 10, 2024 |
| Umedica Laboratories USA Inc. | 3 | tablet; kit | Generic drugs (ANDA) | January 9, 2026 |
| Bryant Ranch Prepack | 2 | tablet, film coated | Generic drugs (ANDA) | January 30, 2023 |
| Lupin Pharmaceuticals, Inc. | 2 | tablet, film coated | Generic drugs (ANDA) | January 9, 2024 |
| Zydus Lifesciences Limited | 2 | tablet, film coated | Generic drugs (ANDA) | June 13, 2023 |
| Zydus Pharmaceuticals USA Inc. | 2 | tablet, film coated | Generic drugs (ANDA) | June 13, 2023 |
| Aphena Pharma Solutions - Tennessee, LLC | 1 | tablet, film coated | Generic drugs (ANDA) | January 30, 2023 |
| Harrow Eye, LLC | 1 | spray | New drug applications (NDA) | October 20, 2021 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 21 | 75% |
| Kit | 4 | 14.3% |
| Tablet | 2 | 7.1% |
| Spray | 1 | 3.6% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 27 | 96.4% |
| New drug applications (NDA) | 1 | 3.6% |
Pharmacologic classes
| Class | Products |
|---|---|
| Cholinergic Receptor Agonist | 24 |
| Partial Cholinergic Nicotinic Agonist | 24 |
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.