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

StrengthQuantityDescriptionNDC
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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