Fenofibrate Tablet
NDC Package 33342-347-10

11-digit billing NDC: 33342034710
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Fenofibrate tablets are contraindicated in: • patients with severe renal impairment, including those receiving dialysis [see Clinical Pharmacology (12.3)].• patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities [see Warnings and Precautions (5.2)].• patients with preexisting gallbladder disease [see Warnings and Precautions (5.5)].• nursing mothers [see Use in Specific Populations (8.2)] • patients with known hypersensitivity to fenofibrate or fenofibric acid [see Warnings and Precautions (5.9)]. This formulation utilizes a tablet delivery system. Marketed by Macleods Pharmaceuticals Limited, this product is identified by NDC 33342-347 and is authorized under FDA application ANDA210379.

Identification & Billing

NDC Package Code
33342-347-10
Package Description
90 TABLET in 1 CONTAINER
Product Code
33342-347
11-Digit Billing Format
33342034710
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 54 mg/1
Pharmacologic Class
Peroxisome Proliferator Receptor alpha Agonist - [EPC] (Established Pharmacologic Class)
Usage Information
Fenofibrate tablets are contraindicated in: • patients with severe renal impairment, including those receiving dialysis [see Clinical Pharmacology (12.3)].• patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities [see Warnings and Precautions (5.2)].• patients with preexisting gallbladder disease [see Warnings and Precautions (5.5)].• nursing mothers [see Use in Specific Populations (8.2)] • patients with known hypersensitivity to fenofibrate or fenofibric acid [see Warnings and Precautions (5.9)].

Regulatory & Marketing

Labeler Name
Macleods Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA210379
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-21-2026
Listing Expiration
12-31-2027
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 (33342-347). Click a package code to view its specific billing and regulatory data.

33342-347-12
10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK
33342-347-47
9 BLISTER PACK in 1 CARTON / 14 TABLET in 1 BLISTER PACK

* 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 33342-347-10 identifies a specific commercial package of 90 tablet in 1 container 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 January 21, 2026. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 33342034710. 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)
33342-347-10
11-Digit CMS (5-4-2)
33342-0347-10

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