Icosapent Ethyl Capsule
NDC Package 0054-0621-27

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

Package Information

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 Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 0054-0621 and is authorized under FDA application ANDA209457.

Identification & Billing

NDC Package Code
0054-0621-27
Package Description
240 CAPSULE in 1 BOTTLE
Product Code
0054-0621
11-Digit Billing Format
00054062127
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
240 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Icosapent Ethyl
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 .5 g/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
Hikma Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA209457
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-04-2020
Listing Expiration
12-31-2026
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 0054-0621-27 identifies a specific commercial package of 240 capsule in 1 bottle of Icosapent Ethyl, a human prescription drug labeled by Hikma Pharmaceuticals Usa 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 Hikma Pharmaceuticals Usa Inc. on November 04, 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 Hikma Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00054062127. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 240 total billable units per package. 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 (4-4-2)
0054-0621-27
11-Digit CMS (5-4-2)
00054-0621-27

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