Riluzole Oral Film
NDC Package 10094-355-01

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

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 Oral films 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 film delivery system. Marketed by Aquestive Therapeutics, this product is identified by NDC 10094-355.

Identification & Billing

NDC Package Code
10094-355-01
Package Description
1 FILM in 1 POUCH
Product Code
10094-355
11-Digit Billing Format
10094035501

Clinical Specifications

Proprietary Name
Riluzole Oral
Non-Proprietary Name
Riluzole Oral
Substance Name
Riluzole
Dosage Form
Film - A thin layer or coating.
Active Ingredient(s)
RILUZOLE 50 mg/1
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
Aquestive Therapeutics
Product Type
Drug For Further Processing
Marketing Category
EXPORT ONLY - A product that is only exported and not marketed in the United States.
Start Marketing Date
12-05-2025
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (10094-355). Click a package code to view its specific billing and regulatory data.

10094-355-11
1 FILM in 1 POUCH
10094-355-21
1 FILM in 1 POUCH
10094-355-31
1 FILM in 1 POUCH
10094-355-41
1 FILM in 1 POUCH
10094-355-51
1 FILM in 1 POUCH
10094-355-61
1 FILM in 1 POUCH

* 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 10094-355-01 identifies a specific commercial package of 1 film in 1 pouch of Riluzole Oral (UNFINISHED drug), drug for further processing labeled by Aquestive Therapeutics. This film 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 Aquestive Therapeutics on December 05, 2025. 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 Aquestive Therapeutics product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10094035501. 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)
10094-355-01
11-Digit CMS (5-4-2)
10094-0355-01

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