Vascepa Capsule
NDC Package 52937-101-08

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Vascepa (icosapent ethyl) capsules is icosapent ethyl is used along with certain other cholesterol medications ("statins" such as atorvastatin, simvastatin) to reduce the risk of heart attack, stroke, and certain types of heart problems that require treatment in a hospital. This formulation utilizes a capsule delivery system. Marketed by Amarin Pharma Inc., this product is identified by NDC 52937-101 and is authorized under FDA application NDA202057.

Identification & Billing

NDC Package Code
52937-101-08
Package Description
1 BLISTER PACK in 1 CARTON / 8 CAPSULE in 1 BLISTER PACK
Product Code
52937-101
11-Digit Billing Format
52937010108
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Vascepa
Non-Proprietary Name
Icosapent Ethyl
Substance Name
Icosapent Ethyl
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ICOSAPENT ETHYL 1000 mg/1
Usage Information
Icosapent ethyl is used along with certain other cholesterol medications ("statins" such as atorvastatin, simvastatin) to reduce the risk of heart attack, stroke, and certain types of heart problems that require treatment in a hospital. It is also used along with a proper diet to help lower fats (triglycerides) in the blood. Icosapent ethyl is a type of omega-3 fatty acid, a fat found in fish oil. It is thought to work by decreasing the amount of triglycerides made by the body. In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details.

Regulatory & Marketing

Labeler Name
Amarin Pharma Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA202057
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-01-2012
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 52937-101-08 identifies a specific commercial package of 1 blister pack in 1 carton / 8 capsule in 1 blister pack of Vascepa, a human prescription drug labeled by Amarin Pharma Inc.. This capsule is formulated for oral use and contains icosapent ethyl as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Amarin Pharma Inc. on October 01, 2012. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Icosapent ethyl is used along with certain other cholesterol medications ("statins" such as atorvastatin, simvastatin) to reduce the risk of heart attack, stroke, and certain types of heart problems that require treatment in a hospital. It is also used along with a proper diet to help lower fats (triglycerides) in the blood. Icosapent ethyl is a type of omega-3 fatty acid, a fat found in fish oil. It is thought to work by decreasing the amount of triglycerides made by the body. In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details.

How is this Amarin Pharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52937010108. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
52937-101-08
11-Digit CMS (5-4-2)
52937-0101-08

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.