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  5. NDC Package Code: 64406-005-01 Tecfidera

NDC Package 64406-005-01 Tecfidera

Dimethyl Fumarate Capsule 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:
64406-005-01
Package Description:
1 BOTTLE, PLASTIC in 1 CARTON / 14 CAPSULE in 1 BOTTLE, PLASTIC
Product Code:
64406-005
Proprietary Name:
Tecfidera
Non-Proprietary Name:
Dimethyl Fumarate
Substance Name:
Dimethyl Fumarate
Usage Information:
Dimethyl fumarate is used to treat multiple sclerosis (MS). It is not a cure for MS. It helps decrease the number of episodes of worsening MS.
11-Digit NDC Billing Format:
64406000501
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1373483 - dimethyl fumarate 120 MG Delayed Release Oral Capsule
  • RxCUI: 1373489 - Tecfidera 120 MG Delayed Release Oral Capsule
  • RxCUI: 1373489 - dimethyl fumarate 120 MG Delayed Release Oral Capsule [Tecfidera]
  • RxCUI: 1373491 - dimethyl fumarate 240 MG Delayed Release Oral Capsule
  • RxCUI: 1373493 - Tecfidera 240 MG Delayed Release Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Biogen Inc.
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DIMETHYL FUMARATE 120 mg/1
    • Sample Package:
    No
    FDA Application Number:
    NDA204063
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    03-27-2013
    Listing Expiration Date:
    12-31-2025
    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 64406-005-01?

    The NDC Packaged Code 64406-005-01 is assigned to a package of 1 bottle, plastic in 1 carton / 14 capsule in 1 bottle, plastic of Tecfidera, a human prescription drug labeled by Biogen Inc.. The product's dosage form is capsule and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 64406-005 included in the NDC Directory?

    Yes, Tecfidera with product code 64406-005 is active and included in the NDC Directory. The product was first marketed by Biogen Inc. on March 27, 2013 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 64406-005-01?

    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 1.

    What is the 11-digit format for NDC 64406-005-01?

    The 11-digit format is 64406000501. 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 5-3-2 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
    5-3-264406-005-015-4-264406-0005-01