Icosapent Ethyl Liquid
NDC Package 71215-101-11

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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.

Icosapent Ethyl liquids 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 liquid delivery system. Marketed by Nissui Corporation, this product is identified by NDC 71215-101.

Identification & Billing

NDC Package Code
71215-101-11
Package Description
180 kg in 1 DRUM
Product Code
71215-101
11-Digit Billing Format
71215010111

Clinical Specifications

Proprietary Name
Icosapent Ethyl
Non-Proprietary Name
Icosapent Ethyl
Substance Name
Icosapent Ethyl
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Active Ingredient(s)
ICOSAPENT ETHYL .998 kg/kg
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
Nissui Corporation
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
06-15-2020
Listing Expiration
12-31-2026
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 71215-101-11 identifies a specific commercial package of 180 kg in 1 drum of Icosapent Ethyl (UNFINISHED drug), drug for further processing labeled by Nissui Corporation. This liquid 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 Nissui Corporation on June 15, 2020. The current certification is valid through December 31, 2026.

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 Nissui Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71215010111. 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)
71215-101-11
11-Digit CMS (5-4-2)
71215-0101-11

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