Fenofibrate Tablet
NDC Package 70518-2907-0

11-digit billing NDC: 70518290700
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Fenofibrate tablets is fenofibrate tablet is contraindicated in:patients with severe renal impairment, including those receiving dialysis [see Clinical Pharmacology (12.3)]. This formulation utilizes a tablet delivery system. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-2907 and is authorized under FDA application ANDA213864.

Identification & Billing

NDC Package Code
70518-2907-0
Package Description
90 TABLET in 1 BOTTLE, PLASTIC
Product Code
70518-2907
11-Digit Billing Format
70518290700
RxNorm Crosswalk
RxCUI: 349287 - fenofibrate 160 MG Oral Tablet

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 160 mg/1
Pharmacologic Class
Peroxisome Proliferator Receptor alpha Agonist - [EPC] (Established Pharmacologic Class)
Usage Information
Fenofibrate tablet is 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
Remedyrepack Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA213864
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-13-2020
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 (70518-2907). Click a package code to view its specific billing and regulatory data.

70518-2907-1
90 TABLET in 1 BOTTLE, PLASTIC

* 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 70518-2907-0 identifies a specific commercial package of 90 tablet in 1 bottle, plastic of Fenofibrate, a human prescription drug labeled by Remedyrepack Inc.. 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 Remedyrepack Inc. on October 13, 2020. The current certification is valid through December 31, 2027.

How is this Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518290700. 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)
70518-2907-0
11-Digit CMS (5-4-2)
70518-2907-00

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