Rezdiffra Tablet, Coated
NDC Package 82576-080-90

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Rezdiffra (resmetirom) tablets is rEZDIFFRA is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).This indication is approved under accelerated approval based on improvement of NASH and fibrosis [see Clinical Studies (14)]. This formulation utilizes a tablet, coated delivery system. Marketed by Madrigal Pharmaceuticals, Inc., this product is identified by NDC 82576-080 and is authorized under FDA application NDA217785.

Identification & Billing

NDC Package Code
82576-080-90
Package Description
90 TABLET, COATED in 1 BOTTLE
Product Code
82576-080
11-Digit Billing Format
82576008090
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Rezdiffra
Non-Proprietary Name
Resmetirom
Substance Name
Resmetirom
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
RESMETIROM 80 mg/1
Pharmacologic Class
Usage Information
REZDIFFRA is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).This indication is approved under accelerated approval based on improvement of NASH and fibrosis [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.Limitations of UseAvoid use of REZDIFFRA in patients with decompensated cirrhosis [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

Regulatory & Marketing

Labeler Name
Madrigal Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA217785
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-14-2024
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 (82576-080). Click a package code to view its specific billing and regulatory data.

82576-080-30
30 TABLET, COATED 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 82576-080-90 identifies a specific commercial package of 90 tablet, coated in 1 bottle of Rezdiffra, a human prescription drug labeled by Madrigal Pharmaceuticals, Inc.. This tablet, coated is formulated for oral use and contains resmetirom 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 Madrigal Pharmaceuticals, Inc. on March 14, 2024. The current certification is valid through December 31, 2026.

How is this Madrigal Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82576008090. 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)
82576-080-90
11-Digit CMS (5-4-2)
82576-0080-90

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