Tysabri Injection
NDC Package 64406-008-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Tysabri (natalizumab) injection is a medication used to treat multiple sclerosis-MS. This formulation utilizes a injection delivery system. Marketed by Biogen Inc., this product is identified by NDC 64406-008 and is authorized under FDA application BLA125104.

Identification & Billing

NDC Package Code
64406-008-01
Package Description
1 VIAL, SINGLE-USE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-USE
Product Code
64406-008
11-Digit Billing Format
64406000801
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tysabri
Non-Proprietary Name
Natalizumab
Substance Name
Natalizumab
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
NATALIZUMAB 300 mg/15mL
Pharmacologic Class
Usage Information
This medication is used to treat multiple sclerosis-MS. It is not a cure for MS, but it is thought to help by preventing your immune system from attacking the nerves in your brain and spinal cord. It helps decrease the number of episodes of worsening and may prevent or delay disability. Natalizumab is also used to treat a bowel condition called Crohn's disease (CD) when it is moderate to severe and/or keeps coming back. It is not a cure for CD, but it is thought to work by preventing your immune system from causing inflammation/swelling within your bowels. Natalizumab is a protein called a monoclonal antibody.

Regulatory & Marketing

Labeler Name
Biogen Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125104
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
11-23-2004
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

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 64406-008-01 identifies a specific commercial package of 1 vial, single-use in 1 carton / 15 ml in 1 vial, single-use of Tysabri, a human prescription drug labeled by Biogen Inc.. This injection is formulated for intravenous use and contains natalizumab 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 Biogen Inc. on November 23, 2004. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat multiple sclerosis-MS. It is not a cure for MS, but it is thought to help by preventing your immune system from attacking the nerves in your brain and spinal cord. It helps decrease the number of episodes of worsening and may prevent or delay disability. Natalizumab is also used to treat a bowel condition called Crohn's disease (CD) when it is moderate to severe and/or keeps coming back. It is not a cure for CD, but it is thought to work by preventing your immune system from causing inflammation/swelling within your bowels. Natalizumab is a protein called a monoclonal antibody.

How is this Biogen Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64406000801. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
64406-008-01
11-Digit CMS (5-4-2)
64406-0008-01

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