er Carton
INGREDIENTS AND APPEARANCE
VASCEPA
icosapent ethyl capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52937-001
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
icosapent ethyl (UNII: 6GC8A4PAYH) (icosapent - UNII:AAN7QOV9EA) icosapent ethyl 1000 mg
Inactive Ingredients
Ingredient Name
Strength
Tocopherol (UNII: R0ZB2556P8) 2 mg
Gelatin, Unspecified (UNII: 2G86QN327L)
Sorbitol (UNII: 506T60A25R)
Glycerin (UNII: PDC6A3C0OX)
Maltitol (UNII: D65DG142WK)
Water (UNII: 059QF0KO0R)
Product Characteristics
Color YELLOW (Amber) Score no score
Shape OVAL (Oblong) Size 25mm
Flavor Imprint Code Vascepa
Contains
Packaging
#
Item Code
Package Description
Marketing Start Date
Marketing End Date
1NDC:52937-001-04 4 in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2012
2NDC:52937-001-20 120 in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2012
3NDC:52937-001-21 120 in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2012
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
NDA NDA202057 10/01/2012
VASCEPA
icosapent ethyl capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52937-101
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
icosapent ethyl (UNII: 6GC8A4PAYH) (icosapent - UNII:AAN7QOV9EA) icosapent ethyl 1000 mg
Inactive Ingredients
Ingredient Name
Strength
Tocopherol (UNII: R0ZB2556P8) 2 mg
Gelatin, Unspecified (UNII: 2G86QN327L)
Sorbitol (UNII: 506T60A25R)
Glycerin (UNII: PDC6A3C0OX)
Maltitol (UNII: D65DG142WK)
Water (UNII: 059QF0KO0R)
Product Characteristics
Color YELLOW (Amber) Score no score
Shape OVAL (Oblong) Size 25mm
Flavor Imprint Code Vascepa
Contains
Packaging
#
Item Code
Package Description
Marketing Start Date
Marketing End Date
1NDC:52937-101-08 1 in 1 CARTON 10/01/2012
1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
NDA NDA202057 10/01/2012
VASCEPA
icosapent ethyl capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52937-003
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name
