Drug
Who makes varenicline?
13 companies list varenicline as a human prescription drug, including under the names Tyrvaya. Forms: kit; spray; tablet; tablet, film coated. Routes: nasal, oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing varenicline
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Apotex Inc.Canada | kit; tablet, film coated | ANDAANDA201962 | 5 | 6 |
| International Medication Systems, Ltd.United States | tablet, film coated | ANDAANDA201962, ANDA211862, ANDA215048 | 4 | 3 |
| Aurobindo Pharma LimitedIndia | kit; tablet, film coated | ANDAANDA214595 | 3 | 6 |
| Macleods Pharmaceuticals LimitedIndia | kit; tablet, film coated | ANDAANDA215048 | 3 | 5 |
| Nivagen Pharmaceuticals LLCUnited States | kit; tablet, film coated | ANDAANDA217115 | 3 | 2 |
| UMEDICA LABORATORIES PRIVATE LIMITEDIndia | kit; tablet | ANDAANDA218985 | 3 | 1 |
| Lupin LimitedIndia | tablet, film coated | ANDAANDA211862 | 2 | 14 |
| Zydus Lifesciences LimitedIndia | tablet, film coated | ANDAANDA216723 | 2 | 12 |
| Bryant Ranch PrepackUnited States | tablet, film coated | ANDAANDA201962 | 2 | 1 |
| Golden State Medical Supply Inc.United States | tablet, film coated | ANDAANDA201962 | 2 | 1 |
| Zydus Pharmaceuticals USA Inc.India | tablet, film coated | ANDAANDA216723 | 2 | 1 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet, film coated | ANDAANDA201962 | 1 | 0 |
| Oyster Point Pharma, Inc. | spray | NDANDA213978 | 1 | 0 |
Bulk ingredient listings
- Maithri Drugs Private LimitedIndia · 1 NDC
- Viatris Inc.India · 1 NDC
Enquiry
Common questions
- Who makes varenicline?
- 13 companies list varenicline as a human prescription drug in the openFDA NDC Directory, led by Apotex Inc., International Medication Systems, Ltd., Aurobindo Pharma Limited, Macleods Pharmaceuticals Limited, Nivagen Pharmaceuticals LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Tyrvaya?
- 12 companies list varenicline under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies varenicline active ingredient?
- 2 companies list varenicline as a bulk ingredient, including Maithri Drugs Private Limited, Viatris Inc..