FDA labels
Search the openFDA drug-label export by label identifier, NDC, application, RxCUI, UNII, product name, or manufacturer.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report.
Label matches#
| Label | Generic name | Manufacturer | SPL set ID | Effective date | Safety fields | Match |
|---|---|---|---|---|---|---|
| Varenicline tartrate | VARENICLINE TARTRATE | A-S Medication Solutions | e10d320a-adf2-4f1d-a576-9685e4551230 | 2026-06-22 | Warnings, Adverse reactions | Name/manufacturer search |
| VARENICLINE | VARENICLINE | Umedica Laboratories USA Inc. | f2e57493-d099-4055-8e92-67611c8d20f4 | 2026-06-22 | Warnings, Adverse reactions | Name/manufacturer search |
| VARENICLINE | VARENICLINE | A-S Medication Solutions | 8a06d177-0e62-457d-b0c8-47f60a313a1c | 2026-06-22 | Warnings, Adverse reactions | Name/manufacturer search |
| Varenicline | VARENICLINE TARTRATE | Ajanta Pharma USA Inc. | 2f86bb7b-c6a6-4915-8ba1-17251540971c | 2026-06-19 | Warnings, Adverse reactions | Name/manufacturer search |
| Varenicline | VARENICLINE TARTRATE | REMEDYREPACK INC. | d759167f-e0b2-46d5-a34a-3c8858e39590 | 2026-04-29 | Warnings, Adverse reactions | Name/manufacturer search |
| Varenicline | VARENICLINE TARTRATE | Marlex Pharmaceuticals, Inc. | 29b6b4ca-aeef-1295-e063-6394a90a21b9 | 2026-03-23 | Warnings, Adverse reactions | Name/manufacturer search |
| Varenicline | VARENICLINE TARTRATE | Par Health USA, LLC | 9e5c0ef3-3179-4d7b-bc76-901473c73ce8 | 2026-02-10 | Warnings, Adverse reactions | Name/manufacturer search |
| varenicline | VARENICLINE TARTRATE | AvKARE | 0552d7ff-9fe8-9c9f-e063-6394a90a79fe | 2026-01-19 | Warnings, Adverse reactions | Name/manufacturer search |
| varenicline tartrate | VARENICLINE TARTRATE | Glenmark Pharmaceuticals Inc., USA | e8a06e8e-1938-412c-a98a-28f0a29fe3ac | 2026-01-07 | Warnings, Adverse reactions | Name/manufacturer search |
| Varenicline | VARENICLINE TARTRATE | American Health Packaging | 16a03b5e-03e0-4b0b-92a4-aaf0669906f7 | 2025-12-10 | Warnings, Adverse reactions | Name/manufacturer search |
| Varenicline | VARENICLINE TARTRATE | American Health Packaging | 38be1217-cd55-416a-bf4b-6ede6bfd3727 | 2025-12-10 | Warnings, Adverse reactions | Name/manufacturer search |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | Lupin Pharmaceuticals, Inc. | bf20c4cc-1731-4873-8de1-b93d17591e9f | 2025-12-03 | Warnings, Adverse reactions | Name/manufacturer search |
| varenicline tartrate | VARENICLINE TARTRATE | Micro Labs Limited | ee603a5d-9a3c-4dbd-ba89-faf253dc8c42 | 2025-10-31 | Warnings, Adverse reactions | Name/manufacturer search |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | Kanchan Healthcare Inc | 1624125c-a0c7-49ee-be00-9bfae4ff9bf5 | 2025-10-14 | Warnings, Adverse reactions | Name/manufacturer search |
| Varenicline | VARENICLINE | Macleods Pharmaceuticals Limited | c325d582-8f43-40ea-b348-87837de97a07 | 2025-09-18 | Warnings, Adverse reactions | Name/manufacturer search |
| varenicline | VARENICLINE | Nivagen Pharmaceuticals Inc. | 077ec752-4145-4592-9ee1-6fdc9a04795a | 2025-08-31 | Warnings, Adverse reactions | Name/manufacturer search |
| VARENICLINE | VARENICLINE | Golden State Medical Supply, Inc. | fa5a2672-2378-c27f-e053-6294a90aba65 | 2025-06-02 | Warnings, Adverse reactions | Name/manufacturer search |
| Varenicline | VARENICLINE | Aurobindo Pharma Limited | 0004a0bb-87c0-46f8-b36a-95c98107395d | 2025-05-08 | Warnings, Adverse reactions | Name/manufacturer search |
| varenicline tartrate | VARENICLINE TARTRATE | Dr. Reddys Laboratories Inc. | 16ee0a83-88d7-97de-1e07-f9e6dcb5c934 | 2025-04-25 | Warnings, Adverse reactions | Name/manufacturer search |
| VARENICLINE | VARENICLINE | Apotex Corp | 78d1857f-8708-5410-792f-4a3e5e7971a5 | 2025-04-10 | Warnings, Adverse reactions | Name/manufacturer search |
| VARENICLINE TARTRATE | VARENICLINE TARTRATE | Leading Pharma, LLC | fdb36cfa-d20a-4fd9-b994-a5d16e4bb438 | 2024-11-28 | Warnings, Adverse reactions | Name/manufacturer search |
| Varenicline | VARENICLINE TARTRATE | Florida Pharmaceutical Products, LLC | 2b9c8b1e-6193-4d8e-9b50-6aca27294263 | 2024-11-05 | Warnings, Adverse reactions | Name/manufacturer search |
| Varenicline tartrate | VARENICLINE TARTRATE | Indoco Remedies Limited | cd83bc6c-20f4-42e1-adb4-a3d1d89413f4 | 2024-11-04 | Warnings, Adverse reactions | Name/manufacturer search |
| Varenicline | VARENICLINE TARTRATE | NorthStar RxLLC | 9031aa0d-2f68-4b9d-903f-ac0e95cbf35f | 2024-09-27 | Warnings, Adverse reactions | Name/manufacturer search |
| VARENICLINE | VARENICLINE | Bryant Ranch Prepack | dc0d2c60-b197-4bbf-a3fd-78e0f5a21440 | 2024-07-16 | Warnings, Adverse reactions | Name/manufacturer search |
| varenicline | VARENICLINE TARTRATE | A-S Medication Solutions | 6351047a-9896-4a30-8e49-4d306ce9c9c0 | 2024-06-14 | Warnings, Adverse reactions | Name/manufacturer search |
| varenicline | VARENICLINE TARTRATE | A-S Medication Solutions | 2d5dfa6e-e69d-414a-8ff2-44714debbbe2 | 2024-04-29 | Warnings, Adverse reactions | Name/manufacturer search |
| VARENICLINE | VARENICLINE | Bryant Ranch Prepack | e3cc710d-23d8-4d68-b854-b6f5f4e737fc | 2024-04-02 | Warnings, Adverse reactions | Name/manufacturer search |
| Varenicline | VARENICLINE | Zydus Pharmaceuticals USA Inc. | 1d4c9535-f185-4ea3-9140-60c4bb77f736 | 2024-02-10 | Warnings, Adverse reactions | Name/manufacturer search |
| varenicline | VARENICLINE TARTRATE | Major Pharmaceuticals | 1297c291-da28-4a73-9c28-d5adee36d7b7 | 2023-12-15 | Warnings, Adverse reactions | Name/manufacturer search |
| Varenicline | VARENICLINE TARTRATE | Camber Pharmaceuticals, Inc. | 7bd1abc8-2689-496b-b3f2-1cefe218ff5a | 2023-11-08 | Warnings, Adverse reactions | Name/manufacturer search |
| Varenicline | VARENICLINE | Zydus Lifesciences Limited | 481b94af-ee34-44be-8ca1-b2415525efac | 2023-09-28 | Name/manufacturer search | |
| varenicline | VARENICLINE TARTRATE | Ascend Laboratories, LLC | e22e2a6a-66b4-459c-b978-51700e31a1a9 | 2023-09-27 | Warnings, Adverse reactions | Name/manufacturer search |
| VARENICLINE | VARENICLINE | A-S Medication Solutions | 99414eca-c601-431c-8e84-2066b2e8221c | 2023-04-30 | Warnings, Adverse reactions | Name/manufacturer search |
| VARENICLINE | VARENICLINE | A-S Medication Solutions | 92bc4c24-6c4f-4acf-b747-e3ef0cab1297 | 2023-04-25 | Warnings, Adverse reactions | Name/manufacturer search |
| CHANTIX | VARENICLINE TARTRATE | Pfizer Laboratories Div Pfizer Inc | f0ff4f27-5185-4881-a749-c6b7a0ca5696 | 2026-01-23 | Warnings, Adverse reactions | Name/manufacturer search |
| Tyrvaya | VARENICLINE | Oyster Point Pharma, Inc. | 014c93dc-5737-479c-a9f0-aaadac1ac298 | 2024-02-12 | Adverse reactions | Name/manufacturer search |
| CHANTIX | VARENICLINE TARTRATE | Proficient Rx LP | 0fefd790-b526-4f2f-8c83-5f39f7306556 | 2020-02-01 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| CHANTIX | VARENICLINE TARTRATE | Proficient Rx LP | f22e3aef-714b-4014-8d77-83ee03fd1f57 | 2020-01-01 | Warnings, Adverse reactions | Name/manufacturer search |
| CHANTIX | VARENICLINE TARTRATE | Aphena Pharma Solutions - Tennessee, LLC | b4403cea-6300-4d89-8fde-5149a80b08b9 | 2017-12-18 | Warnings, Adverse reactions | Name/manufacturer search |