NDC Package 0378-4145-91 Riluzole

View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

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

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

0378-4145-91

Package Description:

60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Product Code:

0378-4145

Proprietary Name:

Riluzole

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.

11-Digit NDC Billing Format:

00378414591

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

60 EA

Labeler Name:

Mylan Pharmaceuticals Inc.

Sample Package:

FDA Application Number:

ANDA203042

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

07-22-2013

End Marketing Date:

07-31-2025

Listing Expiration Date:

07-31-2025

Exclude Flag:

Code Structure:

0378 - Mylan Pharmaceuticals Inc.
- 0378-4145 - Riluzole
  - 0378-4145-91 - 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

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 disclaimer below.

Frequently Asked Questions

What is NDC 0378-4145-91?

The NDC Packaged Code 0378-4145-91 is assigned to a package of 60 tablet, film coated in 1 bottle, plastic of Riluzole, labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is and is administered via form.

Is NDC 0378-4145 included in the NDC Directory?

No, Riluzole with product code 0378-4145 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Mylan Pharmaceuticals Inc. on July 22, 2013 and its listing in the NDC Directory is set to expire on July 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0378-4145-91?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 60.

What is the 11-digit format for NDC 0378-4145-91?

The 11-digit format is 00378414591. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
4-4-2	0378-4145-91	5-4-2	00378-4145-91

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