blets for the 50 mg and 100 mg strengths and white, capsule shaped tablets for the 150 mg strength.
The 50 mg tablets are plain on one side and debossed with “54/024” on the other side.
The 100 mg tablets are scored on one side and debossed with “54/070” on the other side.
The 150 mg tablets are scored on one side and debossed with “54/150” on the other side.
0054-0010-2150 mg, white tablet, bottle of 60
0054-0010-2550 mg, white tablet, bottle of 100
0054-0011-21100 mg, white tablet, bottle of 60
0054-0011-25100 mg, white tablet, bottle of 100
0054-0012-21150 mg, white tablet, bottle of 60
0054-0012-25150 mg, white tablet, bottle of 100
Store at controlled room temperature 15° to 30°C (59° to 86°F) (see USP) in a tight, light-resistant container.
10001280/04
Revised September 2007
© RLI, 2007
Package Label - Flecainide Acetate Tablets, USP
0054-0010-21
50 mg - bottle of 60
Rx Only
Roxane Laboratories, Inc.
0054-0010-25
50 mg - bottle of 100
Rx Only
Roxane Laboratories, Inc.
0054-0011-21
100 mg - bottle of 60
Rx Only
Roxane Laboratories, Inc.
0054-0011-25
100 mg - bottle of 100
Rx Only
Roxane Laboratories, Inc.
0054-0012-21
150 mg - bottle of 60
Rx Only
Roxane Laboratories, Inc.
0054-0012-25
150 mg - bottle of 100
Rx Only
Roxane Laboratories, Inc.
FLECAINIDE ACETATE
flecainide acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0054-0010
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLECAINIDE ACETATE (FLECAINIDE) FLECAINIDE ACETATE 50 mg
Inactive Ingredients
Ingredient Name Strength
COTTONSEED OIL
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
STARCH, CORN
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 54024
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0054-0010-25 100 TABLET In 1 BOTTLE None
2 0054-0010-21 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) 0054-0011
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLECAINIDE ACETATE (FLECAINIDE) FLECAINIDE ACETATE 100 mg
Inactive Ingredients
Ingredient Name Strength
COTTONSEED OIL
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
STARCH, CORN
