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  5. NDC Package Code: 68543-3161-1 Fenofibric Acid

NDC Package 68543-3161-1 Fenofibric Acid

Capsule, Delayed Release - 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:
68543-3161-1
Package Description:
155000 CAPSULE, DELAYED RELEASE in 1 DRUM
Product Code:
68543-3161
Non-Proprietary Name:
Fenofibric Acid
Substance Name:
Fenofibric Acid
Usage Information:
Fenofibric acid is used along with a proper diet to help lower "bad" cholesterol and fats (such as LDL, triglycerides) and raise "good" cholesterol (HDL) in the blood. It works by increasing the natural substance (enzyme) that breaks down fats in the blood. Fenofibric acid belongs to a group of drugs known as "fibrates." Lowering triglycerides in people with very high triglyceride blood levels may decrease the risk of pancreas disease (pancreatitis). However, fenofibric acid might not lower your risk of a heart attack or stroke. Talk to your doctor about the risks and benefits of fenofibric acid. 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:
68543316101
Product Type:
Drug For Further Processing
Labeler Name:
Fournier Laboratories Ireland Ltd
Dosage Form:
Capsule, Delayed Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Active Ingredient(s):
  • FENOFIBRIC ACID 45 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:
    03-13-2017
    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 68543-3161-1?

    The NDC Packaged Code 68543-3161-1 is assigned to an UNFINISHED drug package of 155000 capsule, delayed release in 1 drum of Fenofibric Acid, drug for further processing labeled by Fournier Laboratories Ireland Ltd. The product's dosage form is capsule, delayed release and is administered via form.

    Is NDC 68543-3161 included in the NDC Directory?

    Yes, Fenofibric Acid is an UNFINISHED PRODUCT with code 68543-3161 that is active and included in the NDC Directory. The product was first marketed by Fournier Laboratories Ireland Ltd on March 13, 2017 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 68543-3161-1?

    The 11-digit format is 68543316101. 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 5-4-1 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
    5-4-168543-3161-15-4-268543-3161-01