Data / Drug companies / Varenicline tartrate
Varenicline tartrate: 23 companies and 58 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Varenicline tartrate is listed in the FDA National Drug Code Directory by 23 companies, with 58 products in commercial distribution. 52 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; kit, and the newest product started marketing on April 29, 2026.
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- Companies listing it
- 23
- Products
- 58
- Generic (ANDA) products
- 52 (89.7%)
- Application numbers
- 12
- Routes
- Oral
- Brand names
- Varenicline, Varenicline, Chantix
- openFDA record search
- api.fda.gov
Companies that list varenicline tartrate
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| A-S Medication Solutions | 4 | tablet, film coated | Generic drugs (ANDA) | November 1, 2024 |
| Dr. Reddy's Laboratories Inc. | 4 | kit; tablet, film coated | Generic drugs (ANDA) | December 13, 2024 |
| Ajanta Pharma USA Inc. | 3 | tablet, film coated; kit | Generic drugs (ANDA) | January 31, 2024 |
| Ascend Laboratories, LLC | 3 | tablet, film coated; kit | Generic drugs (ANDA) | August 25, 2023 |
| AvKARE | 3 | tablet, film coated; kit | Generic drugs (ANDA) | September 14, 2023 |
| Camber Pharmaceuticals, Inc. | 3 | tablet, film coated; kit | Generic drugs (ANDA) | October 23, 2023 |
| Florida Pharmaceutical Products, LLC | 3 | tablet, film coated; kit | Generic drugs (ANDA) | November 1, 2024 |
| Glenmark Pharmaceuticals Inc., USA | 3 | tablet, film coated; kit | Generic drugs (ANDA) | August 22, 2023 |
| Indoco Remedies Limited | 3 | tablet, film coated; kit | Generic drugs (ANDA) | November 1, 2024 |
| Kanchan Healthcare Inc | 3 | tablet, film coated; kit | Generic drugs (ANDA) | October 1, 2023 |
| Leading Pharma, LLC | 3 | tablet, film coated; kit | Generic drugs (ANDA) | October 1, 2023 |
| Major Pharmaceuticals | 3 | tablet, film coated; kit | Generic drugs (ANDA) | December 18, 2023 |
| Micro Labs Limited | 3 | tablet, film coated; kit | Generic drugs (ANDA) | December 1, 2025 |
| NorthStar RxLLC | 3 | tablet, film coated; kit | Generic drugs (ANDA) | September 23, 2024 |
| Par Health USA, LLC | 3 | tablet, film coated; kit | Generic drugs (ANDA) | September 21, 2021 |
| Pfizer Laboratories Div Pfizer Inc | 3 | tablet, film coated; kit | New drug applications (NDA) | May 10, 2006 |
| Marlex Pharmaceuticals, Inc. | 2 | tablet, film coated | Generic drugs (ANDA) | January 1, 2025 |
| American Health Packaging | 1 | tablet, film coated | Generic drugs (ANDA) | December 9, 2025 |
| Aphena Pharma Solutions - Tennessee, LLC | 1 | tablet, film coated | New drug applications (NDA) | May 10, 2006 |
| Lupin Pharmaceuticals, Inc. | 1 | kit | Generic drugs (ANDA) | March 20, 2024 |
| Proficient Rx LP | 1 | kit | New drug applications (NDA) | May 10, 2006 |
| Proficient Rx LP | 1 | tablet, film coated | New drug applications (NDA) | May 10, 2006 |
| Remedyrepack Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | April 29, 2026 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 40 | 69% |
| Kit | 18 | 31% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 52 | 89.7% |
| New drug applications (NDA) | 6 | 10.3% |
Pharmacologic classes
| Class | Products |
|---|---|
| Partial Cholinergic Nicotinic Agonist | 40 |
| Cholinergic Receptor Agonist | 38 |
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.