Ethyl Eicosapentaenoate Oil
NDC Package 66727-602-01

11-digit billing NDC: 66727060201
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Ethyl Eicosapentaenoate oils is a bulk ingredient utilized for pharmaceutical compounding or manufacturing. This formulation utilizes a oil delivery system. Marketed by Nisshin Pharma Inc., this product is identified by NDC 66727-602.

Identification & Billing

NDC Package Code
66727-602-01
Package Description
180 kg in 1 DRUM
Product Code
66727-602
11-Digit Billing Format
66727060201

Clinical Specifications

Proprietary Name
Ethyl Eicosapentaenoate
Non-Proprietary Name
Ethyl Eicosapentaenoate
Substance Name
Icosapent Ethyl
Dosage Form
Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.
Active Ingredient(s)
ICOSAPENT ETHYL 1 kg/kg

Regulatory & Marketing

Labeler Name
Nisshin Pharma Inc.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
09-19-2011
End Marketing Date
11-30-2028
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 66727-602-01 identifies a specific commercial package of 180 kg in 1 drum of Ethyl Eicosapentaenoate (UNFINISHED drug), a bulk ingredient labeled by Nisshin Pharma Inc.. This oil is formulated for 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 Nisshin Pharma Inc. on September 19, 2011.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66727060201. 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)
66727-602-01
11-Digit CMS (5-4-2)
66727-0602-01

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