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  5. NDC Package Code: 68279-001-01 Icosapent Ethyl

NDC Package 68279-001-01 Icosapent Ethyl

Capsule - View Billable Units, 11-Digit Format, RxNorm

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.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
68279-001-01
Package Description:
1 BAG in 1 BOX / 5500 CAPSULE in 1 BAG
Product Code:
68279-001
Non-Proprietary Name:
Icosapent Ethyl
Substance Name:
Icosapent Ethyl
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.
11-Digit NDC Billing Format:
68279000101
Product Type:
Drug For Further Processing
Labeler Name:
Patheon Softgels B.v.
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.
Active Ingredient(s):
  • ICOSAPENT ETHYL 1000 mg/1
    • Sample Package:
    N/A
    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:
    10-01-2012
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Unfinished Product:
    Yes
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 68279-001-01?

    The NDC Packaged Code 68279-001-01 is assigned to an UNFINISHED drug package of 1 bag in 1 box / 5500 capsule in 1 bag of Icosapent Ethyl, drug for further processing labeled by Patheon Softgels B.v.. The product's dosage form is capsule and is administered via form.

    Is NDC 68279-001 included in the NDC Directory?

    Yes, Icosapent Ethyl is an UNFINISHED PRODUCT with code 68279-001 that is active and included in the NDC Directory. The product was first marketed by Patheon Softgels B.v. on October 01, 2012 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 68279-001-01?

    The 11-digit format is 68279000101. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-268279-001-015-4-268279-0001-01