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  5. NDC Package Code: 0378-4145-91 Riluzole

NDC Package 0378-4145-91 Riluzole

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

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
Non-Proprietary Name:
Riluzole
Substance 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
NDC to RxNorm Crosswalk:
  • RxCUI: 199206 - riluzole 50 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mylan Pharmaceuticals Inc.
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • RILUZOLE 50 mg/1
    • Pharmacologic Class(es):
  • Benzothiazole - [EPC] (Established Pharmacologic Class)
  • Benzothiazoles - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA203042
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-22-2013
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 0378-4145 included in the NDC Directory?

    Yes, Riluzole with product code 0378-4145 is active and included in the NDC Directory. 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 December 31, 2024 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20378-4145-915-4-200378-4145-91