Riluzole Powder
NDC Package 65129-1011-0

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Riluzole powders 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 powder delivery system. Marketed by Scinopharm Taiwan Ltd., this product is identified by NDC 65129-1011.

Identification & Billing

NDC Package Code
65129-1011-0
Package Description
5 kg in 1 BAG
Product Code
65129-1011
11-Digit Billing Format
65129101100

Clinical Specifications

Proprietary Name
Riluzole
Non-Proprietary Name
Riluzole
Substance Name
Riluzole
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
RILUZOLE 1 kg/kg
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
Scinopharm Taiwan Ltd.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
12-01-2013
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 65129-1011-0 identifies a specific commercial package of 5 kg in 1 bag of Riluzole (UNFINISHED drug), a bulk ingredient labeled by Scinopharm Taiwan Ltd.. This powder is formulated for 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 Scinopharm Taiwan Ltd. on December 01, 2013. The current certification is valid through December 31, 2026.

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 Scinopharm Taiwan Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65129101100. 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)
65129-1011-0
11-Digit CMS (5-4-2)
65129-1011-00

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