NDC Code(s) : 69238-2597-7, 69238-2598-8
Packager : Amneal Pharmaceuticals LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Icosapent ethyl Icosapent ethyl CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-2597
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ICOSAPENT ETHYL(UNII: 6GC8A4PAYH)
(ICOSAPENT - UNII:AAN7QOV9EA) 		ICOSAPENT ETHYL0.5 g
Inactive Ingredients
Ingredient Name Strength
GELATIN(UNII: 2G86QN327L)
GLYCERIN(UNII: PDC6A3C0OX)
WATER(UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
MALTITOL(UNII: D65DG142WK)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color YELLOW (Amber) Score no score
Shape OVAL Size 16 mm
Flavor Imprint Code 500
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69238-2597-7240 in 1 BOTTLE Type 0: Not a Combination Product11/01/2024
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA217844 11/01/2023
Icosapent ethyl Icosapent ethyl CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-2598
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ICOSAPENT ETHYL(UNII: 6GC8A4PAYH)
(ICOSAPENT - UNII:AAN7QOV9EA) 		ICOSAPENT ETHYL1 g
Inactive Ingredients
Ingredient Name Strength
GELATIN(UNII: 2G86QN327L)
GLYCERIN(UNII: PDC6A3C0OX)
WATER(UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
MALTITOL(UNII: D65DG142WK)
Product Characteristics
Color YELLOW (Amber) Score no score
Shape OVAL (Oblong) Size 26 mm
Flavor Imprint Code 1000
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69238-2598-8120 in 1 BOTTLE Type 0: Not a Combination Product11/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA217844 11/01/2023

LABELER - Amneal Pharmaceuticals LLC(123797875)

REGISTRANT - Strides Pharma Global Pte. Ltd.(659220961)

Establishment
Name Address ID/FEI Business Operations
Strides Pharma Science Limited 918513263 ANALYSIS(69238-2597, 69238-2598), MANUFACTURE(69238-2597, 69238-2598), PACK(69238-2597, 69238-2598)

PRINCIPAL DISPLAY PANEL

Icosapent Ethyl Capsules, 1 gram

NDC 69238-2598-8: Bottle of 120 Capsules

Icosapent ethyl 1 gm label

Rx Only

Icosapent Ethyl Capsules, 0.5 gram

NDC 69238-2597-7: Bottle of 240 Capsules

Icosapent ethyl 1 gm label