Icosapent Ethyl Capsule, Liquid Filled
NDC Package 0480-0127-89

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, liquid filled delivery system. Marketed by Teva Pharmaceuticals, Inc., this product is identified by NDC 0480-0127 and is authorized under FDA application ANDA209525.

Identification & Billing

NDC Package Code
0480-0127-89
Package Description
120 CAPSULE, LIQUID FILLED in 1 BOTTLE
Product Code
0480-0127
11-Digit Billing Format
00480012789
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
120 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Icosapent Ethyl
Non-Proprietary Name
Icosapent Ethyl
Substance Name
Icosapent Ethyl
Dosage Form
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ICOSAPENT ETHYL 1 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
Teva Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA209525
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-15-2022
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 0480-0127-89 identifies a specific commercial package of 120 capsule, liquid filled in 1 bottle of Icosapent Ethyl, a human prescription drug labeled by Teva Pharmaceuticals, Inc.. This capsule, liquid filled 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 Teva Pharmaceuticals, Inc. on December 15, 2022. 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 Teva Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00480012789. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 120 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)
0480-0127-89
11-Digit CMS (5-4-2)
00480-0127-89

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