Active ingredient
Varenicline
66 finished FDA listings contain Varenicline as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- VARENICLINE, VARENICLINE TARTRATE
- Dosage forms
- Spray, Tablet, Tablet, Film Coated
- Routes
- Nasal, Oral
- Manufacturers / labelers
- 31
- Strengths listed
- .03 mg/.05ml · .5 mg/1 · .5 mg/561 · 1 mg/1 · 1 mg/561
- Brand names in FDA listings
- Chantix, Tyrvaya, Varenicline
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 591622
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 021928 | PF PRISM CV | 2006-05-10 | 4 |
| ANDA 201785 | PH HEALTH | 2021-08-11 | 3 |
| NDA 213978 | OYSTER POINT PHARMA | 2021-10-15 | 1 |
| ANDA 201962 | APOTEX | 2023-01-25 | 11 |
| ANDA 216723 | ZYDUS | 2023-06-12 | 4 |
| ANDA 217151 | KANCHAN HLTHCARE | 2023-07-25 | 4 |
| ANDA 214255 | MANKIND PHARMA | 2023-08-01 | 2 |
| ANDA 214557 | ALKEM LABS LTD | 2023-08-23 | 8 |
| ANDA 214571 | HETERO LABS LTD III | 2023-10-23 | 5 |
| ANDA 211862 | LUPIN | 2023-12-04 | 3 |
| ANDA 217283 | NE RX PHARMA | 2024-03-06 | 2 |
| ANDA 213019 | AJANTA PHARMA LTD | 2024-03-19 | 3 |
| ANDA 215931 | DR REDDYS | 2024-10-01 | 2 |
| ANDA 219106 | REGCON HOLDINGS | 2024-10-29 | 5 |
| ANDA 215048 | MACLEODS PHARMS | 2024-12-09 | 3 |
| ANDA 214595 | AUROBINDO PHARMA | 2025-05-02 | 2 |
| ANDA 218302 | MICRO LABS | 2025-10-29 | 2 |
| ANDA 218985 | UMEDICA | 2026-01-09 | 2 |
Official labeling on DailyMed
- VARENICLINE (VARENICLINE TARTRATE) TABLET, FILM COATED [REMEDYREPACK INC.] · version 3 · 2026-09-23
- VARENICLINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] · version 1 · 2026-09-23
- VARENICLINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ] · version 1 · 2026-08-27
- TYRVAYA (VARENICLINE) SPRAY [OYSTER POINT PHARMA, INC.] · version 15 · 2026-08-24
- VARENICLINE (VARENICLINE TARTRATE) TABLET, FILM COATED VARENICLINE (VARENICLINE TARTRATE) KIT [ASCEND LABORATORIES, LLC] · version 9 · 2026-08-20
- VARENICLINE (VARENICLINE TARTRATE) TABLET, FILM COATED VARENICLINE (VARENICLINE TARTRATE) KIT [AJANTA PHARMA USA INC.] · version 7 · 2026-06-26
- VARENICLINE TARTRATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] · version 2 · 2026-06-23
- VARENICLINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] · version 2 · 2026-06-23
- VARENICLINE (VARENICLINE TARTRATE) TABLET, FILM COATED VARENICLINE (VARENICLINE TARTRATE) KIT [PAR HEALTH USA, LLC] · version 23 · 2026-05-14
- VARENICLINE (VARENICLINE TARTRATE) TABLET, FILM COATED [MARLEX PHARMACEUTICALS, INC.] · version 4 · 2026-03-25
- VARENICLINE TARTRATE TABLET, FILM COATED VARENICLINE TARTRATE KIT [KANCHAN HEALTHCARE INC] · version 1 · 2026-03-02
- CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC] · version 49 · 2026-01-23
Showing the 12 most recent of 38 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.