Fenofibric Acid Capsule, Delayed Release
NDC Package 68543-3161-1

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.

Fenofibric Acid capsules is 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. This formulation utilizes a capsule, delayed release delivery system. Marketed by Fournier Laboratories Ireland Ltd, this product is identified by NDC 68543-3161.

Identification & Billing

NDC Package Code
68543-3161-1
Package Description
155000 CAPSULE, DELAYED RELEASE in 1 DRUM
Product Code
68543-3161
11-Digit Billing Format
68543316101

Clinical Specifications

Proprietary Name
Fenofibric Acid
Non-Proprietary Name
Fenofibric Acid
Substance Name
Fenofibric Acid
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
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.

Regulatory & Marketing

Labeler Name
Fournier Laboratories Ireland Ltd
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
03-13-2017
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 68543-3161-1 identifies a specific commercial package of 155000 capsule, delayed release in 1 drum of Fenofibric Acid (UNFINISHED drug), drug for further processing labeled by Fournier Laboratories Ireland Ltd. This capsule, delayed release is formulated for use and contains fenofibric acid 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 Fournier Laboratories Ireland Ltd on March 13, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Fournier Laboratories Ireland Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68543316101. 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 (5-4-1)
68543-3161-1
11-Digit CMS (5-4-2)
68543-3161-01

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