Chantix
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
Approved
Approval ID
826c77fa-d8b2-48df-8028-720b15912d92
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 19, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
varenicline tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5664
Application NumberNDA021928
Product Classification
M
Marketing Category
C73594
G
Generic Name
varenicline tartrate
Product Specifications
Effective DateDecember 19, 2011
FDA Product Classification
varenicline tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5674
Application NumberNDA021928
Product Classification
M
Marketing Category
C73594
G
Generic Name
varenicline tartrate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 19, 2011
FDA Product Classification
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
VARENICLINE TARTRATEActive
Quantity: 1.0 mg in 1 1
Code: 82269ASB48
Classification: ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT