Icosapent Ethyl (Page 4 of 4)

PRINCIPAL DISPLAY PANEL

NDC 0480-0126-49
Icosapent Ethyl Capsules
500 mg
Rx only
240 Capsules

new
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0480-0127-89
Icosapent Ethyl Capsules
1 gram
Rx only120 Capsules

1
(click image for full-size original)
ICOSAPENT ETHYL icosapent ethyl capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-0126
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ICOSAPENT ETHYL (ICOSAPENT) ICOSAPENT ETHYL 500 mg
Inactive Ingredients
Ingredient Name Strength
.ALPHA.-TOCOPHEROL, DL-
ETHYL ACETATE
GELATIN, UNSPECIFIED
GLYCERIN
FERROSOFERRIC OXIDE
POLYETHYLENE GLYCOL 400
Polyvinyl Acetate Phthalate
PROPYLENE GLYCOL
WATER
Product Characteristics
Color yellow (transparent, filled with yellow oil) Score no score
Shape OVAL Size 15mm
Flavor Imprint Code TV;0126
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0480-0126-49 240 CAPSULE, LIQUID FILLED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209525 09/09/2022
ICOSAPENT ETHYL icosapent ethyl capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-0127
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ICOSAPENT ETHYL (ICOSAPENT) ICOSAPENT ETHYL 1 g
Inactive Ingredients
Ingredient Name Strength
.ALPHA.-TOCOPHEROL, DL-
ETHYL ACETATE
GELATIN, UNSPECIFIED
GLYCERIN
FERROSOFERRIC OXIDE
POLYETHYLENE GLYCOL 400
Polyvinyl Acetate Phthalate
PROPYLENE GLYCOL
WATER
Product Characteristics
Color yellow (transparent, filled with yellow oil) Score no score
Shape OVAL (oblong) Size 25mm
Flavor Imprint Code TEVA;127
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0480-0127-89 120 CAPSULE, LIQUID FILLED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209525 12/15/2022
Labeler — Teva Pharmaceuticals, Inc. (022629579)

Revised: 08/2021 Teva Pharmaceuticals, Inc.

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