varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet
- RxCUI
- 636671
- RxNorm name
- varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet
- Display name
- varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet
- Full name
- varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet
- Term type
- SY
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:39:25
UNII Substances#
No records found.
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| VARENICLINE | VARENICLINE | Bryant Ranch Prepack | e3cc710d-23d8-4d68-b854-b6f5f4e737fc | 2024-04-02 | Warnings, Adverse reactions | 636671 |
| Varenicline | VARENICLINE | Zydus Pharmaceuticals USA Inc. | 1d4c9535-f185-4ea3-9140-60c4bb77f736 | 2024-02-10 | Warnings, Adverse reactions | 636671 |
| varenicline | VARENICLINE TARTRATE | Major Pharmaceuticals | 1297c291-da28-4a73-9c28-d5adee36d7b7 | 2023-12-15 | Warnings, Adverse reactions | 636671 |
| Varenicline | VARENICLINE TARTRATE | Camber Pharmaceuticals, Inc. | 7bd1abc8-2689-496b-b3f2-1cefe218ff5a | 2023-11-08 | Warnings, Adverse reactions | 636671 |
| Varenicline | VARENICLINE | Zydus Lifesciences Limited | 481b94af-ee34-44be-8ca1-b2415525efac | 2023-09-28 | 636671 | |
| VARENICLINE | VARENICLINE | A-S Medication Solutions | 99414eca-c601-431c-8e84-2066b2e8221c | 2023-04-30 | Warnings, Adverse reactions | 636671 |
| CHANTIX | VARENICLINE TARTRATE | Proficient Rx LP | 0fefd790-b526-4f2f-8c83-5f39f7306556 | 2020-02-01 | Boxed warning, Warnings, Adverse reactions | 636671 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed RxNorm Mappings#
| Set ID | RxNorm mappings | Terms | SPL version | Label | Effective |
|---|---|---|---|---|---|
| e3cc710d-23d8-4d68-b854-b6f5f4e737fc | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 101 | These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | 20240402 |
| f0ff4f27-5185-4881-a749-c6b7a0ca5696 | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 49 | These highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX ® (varenicline) tablets, for oral use Initial U.S. Approval: 2006 | 20260123 |
| 9e5c0ef3-3179-4d7b-bc76-901473c73ce8 | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 23 | These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS . VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | 20260210 |
| bf20c4cc-1731-4873-8de1-b93d17591e9f | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 14 | These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE Tablets, for oral use Initial U.S. Approval: 2006 | 20251203 |
| e8a06e8e-1938-412c-a98a-28f0a29fe3ac | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 8 | These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | 20260107 |
| fdb36cfa-d20a-4fd9-b994-a5d16e4bb438 | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 7 | These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | 20241128 |
| e22e2a6a-66b4-459c-b978-51700e31a1a9 | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 7 | These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | 20230927 |
| 2f86bb7b-c6a6-4915-8ba1-17251540971c | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 6 | These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | 20251130 |
| 16ee0a83-88d7-97de-1e07-f9e6dcb5c934 | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 6 | These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS . VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | 20250425 |
| 875351eb-1c25-44ad-9a37-799919216044 | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 6 | These highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX ® (varenicline) tablets, for oral use Initial U.S. Approval: 2006 | 20210326 |
| 78d1857f-8708-5410-792f-4a3e5e7971a5 | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 5 | These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | 20250410 |
| 29b6b4ca-aeef-1295-e063-6394a90a21b9 | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 4 | These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | 20260323 |
| 0fefd790-b526-4f2f-8c83-5f39f7306556 | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 4 | These highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX ® (varenicline) Tablets Initial U.S. Approval: 2006 | 20200201 |
| c325d582-8f43-40ea-b348-87837de97a07 | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 3 | These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | 20250918 |
| fa5a2672-2378-c27f-e053-6294a90aba65 | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 3 | VARENICLINE TABLETS. These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | 20250602 |
| cd83bc6c-20f4-42e1-adb4-a3d1d89413f4 | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 3 | These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | 20241104 |
| 1d4c9535-f185-4ea3-9140-60c4bb77f736 | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 3 | These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | 20240210 |
| 4233fb78-ac6c-49f3-aad8-7e4bee18cac6 | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 3 | These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS . VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | 20230415 |
| 9a0d0273-8099-420a-b4e1-097153a4aecb | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 3 | These highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX ® (varenicline) tablets, for oral use Initial U.S. Approval: 2006 | 20210415 |
| d759167f-e0b2-46d5-a34a-3c8858e39590 | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 2 | These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | 20260429 |
| f2e57493-d099-4055-8e92-67611c8d20f4 | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 2 | These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | 20260121 |
| 0552d7ff-9fe8-9c9f-e063-6394a90a79fe | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 2 | Varenicline Tablets These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. Initial U.S. Approval: 2006 | 20260119 |
| 2d5dfa6e-e69d-414a-8ff2-44714debbbe2 | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 2 | These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | 20240429 |
| 481b94af-ee34-44be-8ca1-b2415525efac | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 2 | Varenicline Tablets | 20230928 |
| 4aa4019c-737f-4906-bfd9-ca37a74e7c40 | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 2 | These highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX® (varenicline) Tablets Initial U.S. Approval: 2006 | 20140603 |
| 826c77fa-d8b2-48df-8028-720b15912d92 | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 2 | These highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX® (varenicline) Tablets Initial U.S. Approval: 2006 | 20111219 |
| ee603a5d-9a3c-4dbd-ba89-faf253dc8c42 | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 1 | These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | 20251031 |
| 1624125c-a0c7-49ee-be00-9bfae4ff9bf5 | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 1 | These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | 20251014 |
| 077ec752-4145-4592-9ee1-6fdc9a04795a | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 1 | These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | 20250831 |
| 0004a0bb-87c0-46f8-b36a-95c98107395d | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 1 | These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | 20250508 |
| 2b9c8b1e-6193-4d8e-9b50-6aca27294263 | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 1 | These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | 20241105 |
| 9031aa0d-2f68-4b9d-903f-ac0e95cbf35f | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 1 | These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | 20240927 |
| 1297c291-da28-4a73-9c28-d5adee36d7b7 | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 1 | These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | 20231215 |
| 7bd1abc8-2689-496b-b3f2-1cefe218ff5a | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 1 | These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | 20231108 |
| 99414eca-c601-431c-8e84-2066b2e8221c | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 1 | These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS. VARENICLINE tablets, for oral use Initial U.S. Approval: 2006 | 20230430 |
| 1053cbe5-dc3d-4d95-93de-0022a22a6ed1 | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 1 | These highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX ® (varenicline) tablets, for oral use Initial U.S. Approval: 2006 | 20170315 |
| b1b95503-1c7a-44e8-b5e0-d50b61db99d5 | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 1 | These highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX® (varenicline) Tablets Initial U.S. Approval: 2006 | 20110720 |
| f990eca6-fe6f-4423-a118-4b7b970995a1 | varenicline 0.5 MG Oral Tablet [PSN] · varenicline 0.5 MG Oral Tablet [SCD] · varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral Tablet [SY] | 3 | 1 | These highlights do not include all the information needed to use CHANTIX safely and effectively. See full prescribing information for CHANTIX. CHANTIX® (varenicline) Tablets Initial U.S. Approval: 2006 | 20100923 |