Rilutek
NDC Package 0075-7700-60

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Rilutek is a medication used to treat a certain type of nerve disease called amyotrophic lateral sclerosis (ALS, also commonly called Lou Gehrig's disease). Marketed by Sanofi-aventis U.s. Llc, this product is identified by NDC 0075-7700 and is authorized under FDA application NDA020599.

Identification & Billing

NDC Package Code
0075-7700-60
Package Description
60 TABLET, FILM COATED in 1 BOTTLE
Product Code
0075-7700
11-Digit Billing Format
00075770060
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA

Clinical Specifications

Proprietary Name
Rilutek
Dosage Form
-
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
Sanofi-aventis U.s. Llc
FDA Application #
NDA020599
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-12-1995
End Marketing Date
06-30-2015
Listing Expiration
06-30-2015
Exclude Flag
D
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 0075-7700-60 identifies a specific commercial package of 60 tablet, film coated in 1 bottle of Rilutek, labeled by Sanofi-aventis U.s. Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Sanofi-aventis U.s. Llc on December 12, 1995. The current certification is valid through June 30, 2015.

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 Sanofi-aventis U.s. Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00075770060. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 total billable units per package. 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 (4-4-2)
0075-7700-60
11-Digit CMS (5-4-2)
00075-7700-60

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