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, for oral use Initial U.S. Approval: 2006
Approved
Approval ID
47c47343-e9b1-4892-b839-84d2919862ed
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 3, 2019
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
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 Code50090-4482
Application NumberNDA021928
Product Classification
M
Marketing Category
C73594
G
Generic Name
varenicline tartrate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 1, 2019
FDA Product Classification
INGREDIENTS (10)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
VARENICLINE TARTRATEActive
Quantity: 1 mg in 1 1
Code: 82269ASB48
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
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
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT