Fenofibric Acid Capsule, Delayed Release
NDC Package 33342-294-12

11-digit billing NDC: 33342029412
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Fenofibric Acid capsules is fenofibric acid delayed-release capsules 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. This formulation utilizes a capsule, delayed release delivery system. Marketed by Macleods Pharmaceuticals Limited, this product is identified by NDC 33342-294 and is authorized under FDA application ANDA207796.

Identification & Billing

NDC Package Code
33342-294-12
Package Description
10 BLISTER PACK in 1 CARTON / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
Product Code
33342-294
11-Digit Billing Format
33342029412
RxNorm Crosswalk
  • RxCUI: 828373 - fenofibric acid 135 MG Delayed Release Oral Capsule
  • RxCUI: 828379 - fenofibric acid 45 MG Delayed Release Oral Capsule

Clinical Specifications

Proprietary Name
Fenofibric Acid
Non-Proprietary Name
Fenofibric Acid
Substance Name
Choline Fenofibrate
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.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CHOLINE FENOFIBRATE 45 mg/1
Pharmacologic Class
Peroxisome Proliferator Receptor alpha Agonist - [EPC] (Established Pharmacologic Class)
Usage Information
Fenofibric acid delayed-release capsules 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 #
ANDA207796
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-26-2024
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 (33342-294). Click a package code to view its specific billing and regulatory data.

33342-294-10
90 CAPSULE, DELAYED RELEASE 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 33342-294-12 identifies a specific commercial package of 10 blister pack in 1 carton / 10 capsule, delayed release in 1 blister pack of Fenofibric Acid, a human prescription drug labeled by Macleods Pharmaceuticals Limited. This capsule, delayed release is formulated for oral use and contains choline 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 February 26, 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: 33342029412. 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)
33342-294-12
11-Digit CMS (5-4-2)
33342-0294-12

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