FDA.reportPublic FDA data

VARENICLINE TARTRATE - Food and Drug Administration

Manufacturer
Food and Drug Administration
Effective date
2026-02-23
Label type
Indexing - Product Concept
Version
8
Source
full-release
Hydrated at
2026-06-05 00:26:57

Label at a glance#

ProductVARENICLINE TARTRATE
Active ingredientVARENICLINE TARTRATE

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
VARENICLINE TARTRATE82269ASB48ACTIM
VARENICLINE TARTRATE82269ASB48ACTIM

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VareniclineVARENICLINE TARTRATEREMEDYREPACK INC.d759167f-e0b2-46d5-a34a-3c8858e395902026-09-21Warnings, Adverse reactionsName fallback
generic name: VARENICLINE TARTRATE
vareniclineVARENICLINE TARTRATEAscend Laboratories, LLCe22e2a6a-66b4-459c-b978-51700e31a1a92026-08-17Warnings, Adverse reactionsName fallback
generic name: VARENICLINE TARTRATE
Varenicline tartrateVARENICLINE TARTRATEA-S Medication Solutionse10d320a-adf2-4f1d-a576-9685e45512302026-06-22Warnings, Adverse reactionsName fallback
brand name: Varenicline tartrate
generic name: VARENICLINE TARTRATE
VareniclineVARENICLINE TARTRATEAjanta Pharma USA Inc.2f86bb7b-c6a6-4915-8ba1-17251540971c2026-06-19Warnings, Adverse reactionsName fallback
generic name: VARENICLINE TARTRATE
VareniclineVARENICLINE TARTRATEMarlex Pharmaceuticals, Inc.29b6b4ca-aeef-1295-e063-6394a90a21b92026-03-23Warnings, Adverse reactionsName fallback
generic name: VARENICLINE TARTRATE
VareniclineVARENICLINE TARTRATEPar Health USA, LLC9e5c0ef3-3179-4d7b-bc76-901473c73ce82026-02-10Warnings, Adverse reactionsName fallback
generic name: VARENICLINE TARTRATE
CHANTIXVARENICLINE TARTRATEPfizer Laboratories Div Pfizer Incf0ff4f27-5185-4881-a749-c6b7a0ca56962026-01-23Warnings, Adverse reactionsName fallback
generic name: VARENICLINE TARTRATE
vareniclineVARENICLINE TARTRATEAvKARE0552d7ff-9fe8-9c9f-e063-6394a90a79fe2026-01-19Warnings, Adverse reactionsName fallback
generic name: VARENICLINE TARTRATE
varenicline tartrateVARENICLINE TARTRATEGlenmark Pharmaceuticals Inc., USAe8a06e8e-1938-412c-a98a-28f0a29fe3ac2026-01-07Warnings, Adverse reactionsName fallback
brand name: varenicline tartrate
generic name: VARENICLINE TARTRATE
VareniclineVARENICLINE TARTRATEAmerican Health Packaging16a03b5e-03e0-4b0b-92a4-aaf0669906f72025-12-10Warnings, Adverse reactionsName fallback
generic name: VARENICLINE TARTRATE
VareniclineVARENICLINE TARTRATEAmerican Health Packaging38be1217-cd55-416a-bf4b-6ede6bfd37272025-12-10Warnings, Adverse reactionsName fallback
generic name: VARENICLINE TARTRATE
VARENICLINE TARTRATEVARENICLINE TARTRATELupin Pharmaceuticals, Inc.bf20c4cc-1731-4873-8de1-b93d17591e9f2025-12-03Warnings, Adverse reactionsName fallback
brand name: VARENICLINE TARTRATE
generic name: VARENICLINE TARTRATE
varenicline tartrateVARENICLINE TARTRATEMicro Labs Limitedee603a5d-9a3c-4dbd-ba89-faf253dc8c422025-10-31Warnings, Adverse reactionsName fallback
brand name: varenicline tartrate
generic name: VARENICLINE TARTRATE
VARENICLINE TARTRATEVARENICLINE TARTRATEKanchan Healthcare Inc1624125c-a0c7-49ee-be00-9bfae4ff9bf52025-10-14Warnings, Adverse reactionsName fallback
brand name: VARENICLINE TARTRATE
generic name: VARENICLINE TARTRATE
varenicline tartrateVARENICLINE TARTRATEDr. Reddys Laboratories Inc.16ee0a83-88d7-97de-1e07-f9e6dcb5c9342025-04-25Warnings, Adverse reactionsName fallback
brand name: varenicline tartrate
generic name: VARENICLINE TARTRATE
VARENICLINE TARTRATEVARENICLINE TARTRATELeading Pharma, LLCfdb36cfa-d20a-4fd9-b994-a5d16e4bb4382024-11-28Warnings, Adverse reactionsName fallback
brand name: VARENICLINE TARTRATE
generic name: VARENICLINE TARTRATE
VareniclineVARENICLINE TARTRATEFlorida Pharmaceutical Products, LLC2b9c8b1e-6193-4d8e-9b50-6aca272942632024-11-05Warnings, Adverse reactionsName fallback
brand name: Varenicline tartrate
generic name: VARENICLINE TARTRATE
Varenicline tartrateVARENICLINE TARTRATEIndoco Remedies Limitedcd83bc6c-20f4-42e1-adb4-a3d1d89413f42024-11-04Warnings, Adverse reactionsName fallback
brand name: Varenicline tartrate
generic name: VARENICLINE TARTRATE
VareniclineVARENICLINE TARTRATENorthStar RxLLC9031aa0d-2f68-4b9d-903f-ac0e95cbf35f2024-09-27Warnings, Adverse reactionsName fallback
generic name: VARENICLINE TARTRATE
vareniclineVARENICLINE TARTRATEA-S Medication Solutions6351047a-9896-4a30-8e49-4d306ce9c9c02024-06-14Warnings, Adverse reactionsName fallback
generic name: VARENICLINE TARTRATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.