Lamzede Injection, Powder, Lyophilized, For Solution
NDC Package 10122-180-10

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

Package Information

Lamzede (velmanase alfa-tycv) injection is lAMZEDE is indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Chiesi Usa, Inc., this product is identified by NDC 10122-180 and is authorized under FDA application BLA761278.

Identification & Billing

NDC Package Code
10122-180-10
Package Description
10 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON
Product Code
10122-180
11-Digit Billing Format
10122018010
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lamzede
Non-Proprietary Name
Velmanase Alfa-tycv
Substance Name
Velmanase Alfa-tycv
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
VELMANASE ALFA-TYCV 10 mg/1
Usage Information
LAMZEDE is indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients.

Regulatory & Marketing

Labeler Name
Chiesi Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761278
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-01-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (10122-180). Click a package code to view its specific billing and regulatory data.

10122-180-02
1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON
10122-180-05
5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON

* 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 10122-180-10 identifies a specific commercial package of 10 injection, powder, lyophilized, for solution in 1 carton of Lamzede, a human prescription drug labeled by Chiesi Usa, Inc.. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains velmanase alfa-tycv 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 Chiesi Usa, Inc. on March 01, 2023. The current certification is valid through December 31, 2026.

How is this Chiesi Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10122018010. 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)
10122-180-10
11-Digit CMS (5-4-2)
10122-0180-10

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