Basic Information
varenicline
0904-7414
Regulatory Information
0904-7414
ANDA214557
C73584
August 23, 2023
USA
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
Human Prescription Drug Label
1
Company Information
191427277
Active Ingredients
MICROCRYSTALLINE CELLULOSE
Code: OP1R32D61U
Class Code: IACT
CROSCARMELLOSE SODIUM
Code: M28OL1HH48
Class Code: IACT
POLYETHYLENE GLYCOL, UNSPECIFIED
Code: 3WJQ0SDW1A
Class Code: IACT
HYPROMELLOSE 2910 (5 MPA.S)
Code: R75537T0T4
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
TRIACETIN
Code: XHX3C3X673
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
FD&C BLUE NO. 2
Code: L06K8R7DQK
Class Code: IACT
FD&C BLUE NO. 1
Code: H3R47K3TBD
Class Code: IACT
FERRIC OXIDE YELLOW
Code: EX438O2MRT
Class Code: IACT
MALTODEXTRIN
Code: 7CVR7L4A2D
Class Code: IACT
STEARIC ACID
Code: 4ELV7Z65AP
Class Code: IACT
Active Moieties
VARENICLINE
Code: W6HS99O8ZO