Flecainide Acetate (Page 6 of 6)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Flecainide Acetate Tablets, USP

50 mg, 100 Tablets

NDC: 42806-817-01

50mg-100ct
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Flecainide Acetate Tablets, USP

100 mg, 100 Tablets

NDC: 42806-818-01

100mg-100ct
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Flecainide Acetate Tablets, USP

150 mg, 100 Tablets

NDC: 42806-819-01

150mg-100ct
(click image for full-size original)
FLECAINIDE ACETATE
flecainide acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42806-817
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
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
STARCH, CORN
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code YH;777
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42806-817-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215599 09/15/2022
FLECAINIDE ACETATE
flecainide acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42806-818
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
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
STARCH, CORN
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code YH;717
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42806-818-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215599 09/15/2022
FLECAINIDE ACETATE
flecainide acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42806-819
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
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
STARCH, CORN
Product Characteristics
Color white Score 2 pieces
Shape CAPSULE Size 14mm
Flavor Imprint Code YH;711
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42806-819-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215599 09/15/2022
Labeler — Epic Pharma, LLC (827915443)
Registrant — Yichang Humanwell Pharmaceutical Co,. Ltd. (527225336)
Establishment
Name Address ID/FEI Operations
Yichang Humanwell Oral Solid Dosge Plant 421371958 manufacture (42806-819), manufacture (42806-817), manufacture (42806-818)

Revised: 12/2023 Epic Pharma, LLC

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