;
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code 54070
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0054-0011-25 100 TABLET In 1 BOTTLE None
2 0054-0011-21 60 TABLET In 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076278 01/14/2003
FLECAINIDE ACETATE
flecainide acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0054-0012
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLECAINIDE ACETATE (FLECAINIDE) FLECAINIDE ACETATE 150 mg
Inactive Ingredients
Ingredient Name Strength
COTTONSEED OIL
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
STARCH, CORN
Product Characteristics
Color WHITE Score 2 pieces
Shape CAPSULE Size 14mm
Flavor Imprint Code 54150
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0054-0012-21 60 TABLET In 1 BOTTLE None
2 0054-0012-25 100 TABLET In 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076278 01/14/2003
Labeler - Roxane Laboratories, Inc (058839929)
Registrant - Roxane Laboratories, Inc (058839929)
Establishment
Name Address ID/FEI Operations
Boehringer Ingelheim Roxane Inc 128407710 MANUFACTURE
Revised: 11/2009Roxane Laboratories, Inc
