Metaxalone Tablet
NDC Package 67296-2349-3

11-digit billing NDC: 67296234903
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Metaxalone tablets is metaxalone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. This formulation utilizes a tablet delivery system. Marketed by Redpharm Drug, this product is identified by NDC 67296-2349 and is authorized under FDA application ANDA207466.

Identification & Billing

NDC Package Code
67296-2349-3
Package Description
30 TABLET in 1 BOTTLE
Product Code
67296-2349
11-Digit Billing Format
67296234903

Clinical Specifications

Proprietary Name
Metaxalone
Non-Proprietary Name
Metaxalone
Substance Name
Metaxalone
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)
METAXALONE 800 mg/1
Pharmacologic Class
Usage Information
Metaxalone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.

Regulatory & Marketing

Labeler Name
Redpharm Drug
Product Type
Human Prescription Drug
FDA Application #
ANDA207466
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-31-2017
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 67296-2349-3 identifies a specific commercial package of 30 tablet in 1 bottle of Metaxalone, a human prescription drug labeled by Redpharm Drug. This tablet is formulated for oral use and contains metaxalone 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 Redpharm Drug on August 31, 2017. The current certification is valid through December 31, 2027.

How is this Redpharm Drug product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67296234903. 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)
67296-2349-3
11-Digit CMS (5-4-2)
67296-2349-03

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