VASCEPA Capsule Ref.[27435] Active ingredients: Eicosapentaenoic acid

Source: FDA, National Drug Code (US) Revision Year: 2020

Product description

VASCEPA, a lipid-regulating agent, is supplied as either a 0.5 gram or a 1 gram amber-colored, liquid-filled soft gelatin capsule for oral use.

Each VASCEPA capsule contains either 0.5 grams of icosapent ethyl (in a 0.5 gram capsule) or 1 gram of icosapent ethyl (in a 1 gram capsule). Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C₂₂H₃₄O₂ and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate with the following chemical structure:

VASCEPA capsules also contain the following inactive ingredients: tocopherol, gelatin, glycerin, maltitol, sorbitol, and purified water.

Dosage Forms and Strengths
VASCEPA capsules are supplied as: 0.5 gram amber-colored, oval, soft-gelatin capsules imprinted with V500 1 gram amber-colored, oblong, soft-gelatin capsules imprinted with VASCEPA

How Supplied

VASCEPA (icosapent ethyl) capsules are supplied as

Strength	Quantity	Description	NDC
0.5 gram capsules	Bottles of 240	amber-colored soft-gelatin capsules imprinted with V500	52937-003-40
1 gram capsules	Bottles of 120	amber-colored soft-gelatin capsules imprinted with VASCEPA	52937-001-20

Distributed by: Amarin Pharma, Inc., Bridgewater, NJ, USA

Manufactured for: Amarin Pharmaceuticals Ireland Limited, Dublin, Ireland

Drugs

Drug	Countries
VASCEPA	Canada, United States

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