icosapent ethyl by Softgel Healthcare Private Limited ICOSAPENT ETHYL capsule

icosapent ethyl by

Drug Labeling and Warnings

icosapent ethyl by is a Prescription medication manufactured, distributed, or labeled by Softgel Healthcare Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ICOSAPENT ETHYL 
icosapent ethyl capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 35916-1738
Route of Administration	ORAL

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

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

Product Characteristics
Color	WHITE (transparent)	Score	no score
Shape	OVAL	Size	14mm
Flavor		Imprint Code	1738
Contains

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

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

ICOSAPENT ETHYL 
icosapent ethyl capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 35916-1592
Route of Administration	ORAL

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

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

Product Characteristics
Color	WHITE (transparent)	Score	no score
Shape	OVAL (oblong)	Size	24mm
Flavor		Imprint Code	1592
Contains

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

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

Labeler - Softgel Healthcare Private Limited (675584180)

Establishment
Name	Address	ID/FEI	Business Operations
Softgel Healthcare Private Limited		675584180	ANALYSIS(35916-1738, 35916-1592) , LABEL(35916-1738, 35916-1592) , MANUFACTURE(35916-1738, 35916-1592) , PACK(35916-1738, 35916-1592)