Lemtrada Injection, Solution, Concentrate
NDC Package 58468-0200-1

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

Package Information

Lemtrada (alemtuzumab) injection is alemtuzumab is used to treat multiple sclerosis (MS). This formulation utilizes a injection, solution, concentrate delivery system. Marketed by Genzyme Corporation, this product is identified by NDC 58468-0200 and is authorized under FDA application BLA103948.

Identification & Billing

NDC Package Code
58468-0200-1
Package Description
1 VIAL, SINGLE-USE in 1 CARTON / 1.2 mL in 1 VIAL, SINGLE-USE
Product Code
58468-0200
11-Digit Billing Format
58468020001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lemtrada
Non-Proprietary Name
Alemtuzumab
Substance Name
Alemtuzumab
Dosage Form
Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
ALEMTUZUMAB 12 mg/1.2mL
Pharmacologic Class
Usage Information
Alemtuzumab is used to treat multiple sclerosis (MS). It is not a cure for MS but it is thought to help by preventing immune system cells (lymphocytes) from attacking the nerves in your brain and spinal cord. It helps decrease the number of relapses and may prevent or delay disability.

Regulatory & Marketing

Labeler Name
Genzyme Corporation
Product Type
Human Prescription Drug
FDA Application #
BLA103948
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
11-18-2014
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 58468-0200-1 identifies a specific commercial package of 1 vial, single-use in 1 carton / 1.2 ml in 1 vial, single-use of Lemtrada, a human prescription drug labeled by Genzyme Corporation. This injection, solution, concentrate is formulated for intravenous use and contains alemtuzumab 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 Genzyme Corporation on November 18, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Alemtuzumab is used to treat multiple sclerosis (MS). It is not a cure for MS but it is thought to help by preventing immune system cells (lymphocytes) from attacking the nerves in your brain and spinal cord. It helps decrease the number of relapses and may prevent or delay disability.

How is this Genzyme Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58468020001. 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 (5-4-1)
58468-0200-1
11-Digit CMS (5-4-2)
58468-0200-01

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