SPL UNCLASSIFIED

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 35916-1738-1

Icosapent Ethyl Capsules

0.5 gram

240 capsules

Rx only

NDC 35916-1592-1

Icosapent Ethyl Capsules

1 gram

240 capsules

Rx only

ICOSAPENT ETHYL
icosapent ethyl capsule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ICOSAPENT ETHYL (UNII: 6GC8A4PAYH) (ICOSAPENT - UNII:AAN7QOV9EA)	ICOSAPENT ETHYL	0.5 g

Ingredient Name	Strength
Inactive Ingredients
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SHELLAC (UNII: 46N107B71O)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:35916-1738-1	240 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA217656	03/01/2025

ICOSAPENT ETHYL
icosapent ethyl capsule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ICOSAPENT ETHYL (UNII: 6GC8A4PAYH) (ICOSAPENT - UNII:AAN7QOV9EA)	ICOSAPENT ETHYL	1 g

Ingredient Name	Strength
Inactive Ingredients
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SHELLAC (UNII: 46N107B71O)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:35916-1592-1	120 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA217656	03/01/2025

Labeler - Softgel Healthcare Private Limited (676666501)

Name	Address	ID/FEI	Business Operations
Establishment
Softgel Healthcare Private Limited		676666501	ANALYSIS(35916-1738, 35916-1592) , LABEL(35916-1738, 35916-1592) , MANUFACTURE(35916-1738, 35916-1592) , PACK(35916-1738, 35916-1592)