Fenofibric Acid Powder
NDC Package 66064-1003-1

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 powders 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 powder delivery system. Marketed by Harman Finochem Limited, this product is identified by NDC 66064-1003.

Identification & Billing

NDC Package Code
66064-1003-1
Package Description
25 kg in 1 DRUM
Product Code
66064-1003
11-Digit Billing Format
66064100301

Clinical Specifications

Proprietary Name
Fenofibric Acid
Non-Proprietary Name
Fenofibric Acid
Substance Name
Fenofibric Acid
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
FENOFIBRIC ACID 25 kg/25kg
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
Harman Finochem Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
01-01-2011
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 66064-1003-1 identifies a specific commercial package of 25 kg in 1 drum of Fenofibric Acid (UNFINISHED drug), a bulk ingredient labeled by Harman Finochem Limited. This powder 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 Harman Finochem Limited on January 01, 2011. 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 Harman Finochem Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66064100301. 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)
66064-1003-1
11-Digit CMS (5-4-2)
66064-1003-01

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