Fenofibrate Tablet
NDC Package 33342-339-12

11-digit billing NDC: 33342033912
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Fenofibrate tablets is indicated as adjunctive therapy to diet: • to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL).  • to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible.  Limitations of Use • Markedly elevated levels of serum TG (e.g. This formulation utilizes a tablet delivery system. Marketed by Macleods Pharmaceuticals Limited, this product is identified by NDC 33342-339 and is authorized under FDA application ANDA210248.

Identification & Billing

NDC Package Code
33342-339-12
Package Description
10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK
Product Code
33342-339
11-Digit Billing Format
33342033912
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fenofibrate
Non-Proprietary Name
Fenofibrate
Substance Name
Fenofibrate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FENOFIBRATE 48 mg/1
Pharmacologic Class
Peroxisome Proliferator Receptor alpha Agonist - [EPC] (Established Pharmacologic Class)
Usage Information
Fenofibrate tablets is indicated as adjunctive therapy to diet: • to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL).  • to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible.  Limitations of Use • Markedly elevated levels of serum TG (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions (5.7)]. • Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1) and Clinical Studies (14.4)].

Regulatory & Marketing

Labeler Name
Macleods Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA210248
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-13-2024
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (33342-339). Click a package code to view its specific billing and regulatory data.

33342-339-07
30 TABLET in 1 BOTTLE
33342-339-10
90 TABLET in 1 BOTTLE
33342-339-15
500 TABLET in 1 BOTTLE

* 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 33342-339-12 identifies a specific commercial package of 10 blister pack in 1 carton / 10 tablet in 1 blister pack of Fenofibrate, a human prescription drug labeled by Macleods Pharmaceuticals Limited. This tablet is formulated for oral use and contains fenofibrate 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 Macleods Pharmaceuticals Limited on November 13, 2024. The current certification is valid through December 31, 2026.

How is this Macleods Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 33342033912. 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 (5-3-2)
33342-339-12
11-Digit CMS (5-4-2)
33342-0339-12

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