Flecainide Acetate (Page 6 of 6)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

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FLECAINIDE ACETATE
flecainide acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: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
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
# Item Code Package Description Multilevel Packaging
1 NDC:0054-0010-25 100 TABLET in 1 BOTTLE None
2 NDC:0054-0010-21 60 TABLET in 1 BOTTLE None
3 NDC:0054-0010-20 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0054-0010-20)
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 Item Code (Source) NDC: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
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
STARCH, CORN
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code 54070
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0054-0011-25 100 TABLET in 1 BOTTLE None
2 NDC:0054-0011-21 60 TABLET in 1 BOTTLE None
3 NDC:0054-0011-20 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0054-0011-20)
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 Item Code (Source) NDC: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
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
# Item Code Package Description Multilevel Packaging
1 NDC:0054-0012-21 60 TABLET in 1 BOTTLE None
2 NDC:0054-0012-25 100 TABLET in 1 BOTTLE None
3 NDC:0054-0012-20 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0054-0012-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076278 01/14/2003
Labeler — West-Ward Pharmaceuticals Corp. (080189610)
Establishment
Name Address ID/FEI Operations
West-Ward Columbus Inc. 058839929 MANUFACTURE (0054-0010), MANUFACTURE (0054-0011), MANUFACTURE (0054-0012)

Revised: 04/2016 West-Ward Pharmaceuticals Corp.

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