CHANTIX (Page 10 of 10)

PRINCIPAL DISPLAY PANEL

Varenicline 0.5 mg tablet
(click image for full-size original)

CHANTIX varenicline tartrate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69189-0492(NDC:0069-0468)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VARENICLINE TARTRATE (VARENICLINE) VARENICLINE 0.5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
TRIACETIN
FD&C BLUE NO. 2
Product Characteristics
Color WHITE Score no score
Shape OVAL (Capsular) Size 8mm
Flavor Imprint Code Pfizer;CHX;0;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69189-0492-1 1 TABLET, FILM COATED in 1 DOSE PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021928 01/22/2016
Labeler — Avera McKennan Hospital (068647668)
Establishment
Name Address ID/FEI Operations
Avera McKennan Hospital 068647668 relabel (69189-0492), repack (69189-0492)

Revised: 03/2017 Avera McKennan Hospital

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