Flecainide Acetate (Page 5 of 5)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 50 mg (30 Tablets Bottle)

NDC 65862-621-30
Rx only
Flecainide Acetate
Tablets, USP
50 mg
AUROBINDO 30 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 50 mg (30 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 100 mg (30 Tablets Bottle)

NDC 65862-622-30 Rx only
Flecainide Acetate
Tablets, USP
100 mgAUROBINDO 30 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 100 mg (30 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 150 mg (30 Tablets Bottle)

NDC 65862-623-30 Rx only
Flecainide Acetate
Tablets, USP
150 mgAUROBINDO 30 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 150 mg (30 Tablets Bottle)
(click image for full-size original)
FLECAINIDE ACETATE flecainide acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-621
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
CROSCARMELLOSE SODIUM
HYDROGENATED COTTONSEED OIL
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape ROUND (Biconvex) Size 7mm
Flavor Imprint Code CC;11
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-621-30 30 TABLET in 1 BOTTLE None
2 NDC:65862-621-01 100 TABLET in 1 BOTTLE None
3 NDC:65862-621-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202821 11/03/2017
FLECAINIDE ACETATE flecainide acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-622
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
CROSCARMELLOSE SODIUM
HYDROGENATED COTTONSEED OIL
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
Product Characteristics
Color WHITE (White to Off-white) Score 2 pieces
Shape ROUND (Biconvex) Size 9mm
Flavor Imprint Code 1;2;CC
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-622-30 30 TABLET in 1 BOTTLE None
2 NDC:65862-622-01 100 TABLET in 1 BOTTLE None
3 NDC:65862-622-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202821 11/03/2017
FLECAINIDE ACETATE flecainide acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-623
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
CROSCARMELLOSE SODIUM
HYDROGENATED COTTONSEED OIL
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
Product Characteristics
Color WHITE (White to Off-white) Score 2 pieces
Shape OVAL (Biconvex) Size 13mm
Flavor Imprint Code 1;3;CC
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-623-30 30 TABLET in 1 BOTTLE None
2 NDC:65862-623-01 100 TABLET in 1 BOTTLE None
3 NDC:65862-623-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202821 11/03/2017
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (65862-621), ANALYSIS (65862-622), ANALYSIS (65862-623), MANUFACTURE (65862-621), MANUFACTURE (65862-622), MANUFACTURE (65862-623)

Revised: 01/2024 Aurobindo Pharma Limited

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