Riluzole Tablet, Film Coated
NDC Package 42291-775-60

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

Package Information

Riluzole tablets is a medication used to treat a certain type of nerve disease called amyotrophic lateral sclerosis (ALS, also commonly called Lou Gehrig's disease). This formulation utilizes a tablet, film coated delivery system. Marketed by Avkare, this product is identified by NDC 42291-775 and is authorized under FDA application ANDA206045.

Identification & Billing

NDC Package Code
42291-775-60
Package Description
60 TABLET, FILM COATED in 1 BOTTLE
Product Code
42291-775
11-Digit Billing Format
42291077560
RxNorm Crosswalk
RxCUI: 199206 - riluzole 50 MG Oral Tablet

Clinical Specifications

Proprietary Name
Riluzole
Non-Proprietary Name
Riluzole
Substance Name
Riluzole
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
RILUZOLE 50 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat a certain type of nerve disease called amyotrophic lateral sclerosis (ALS, also commonly called Lou Gehrig's disease). Riluzole helps to slow down the worsening of this disease and prolong survival. However, it is not a cure for ALS, and it does not reverse nerve damage or muscle weakness. Riluzole is thought to work by protecting the nerves in the brain and spinal cord from too much of a natural substance called glutamate that may be part of the cause of nerve damage.

Regulatory & Marketing

Labeler Name
Avkare
Product Type
Human Prescription Drug
FDA Application #
ANDA206045
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-07-2020
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 42291-775-60 identifies a specific commercial package of 60 tablet, film coated in 1 bottle of Riluzole, a human prescription drug labeled by Avkare. This tablet, film coated is formulated for oral use and contains riluzole 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 Avkare on October 07, 2020. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat a certain type of nerve disease called amyotrophic lateral sclerosis (ALS, also commonly called Lou Gehrig's disease). Riluzole helps to slow down the worsening of this disease and prolong survival. However, it is not a cure for ALS, and it does not reverse nerve damage or muscle weakness. Riluzole is thought to work by protecting the nerves in the brain and spinal cord from too much of a natural substance called glutamate that may be part of the cause of nerve damage.

How is this Avkare product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42291077560. 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)
42291-775-60
11-Digit CMS (5-4-2)
42291-0775-60

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