Velmanase Alfa-tycv Injection, Powder, Lyophilized, For Solution
NDC Package 64538-180-00

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Velmanase Alfa-tycv injection is a bulk ingredient utilized for pharmaceutical compounding or manufacturing. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Rentschler Biopharma Se, this product is identified by NDC 64538-180.

Identification & Billing

NDC Package Code
64538-180-00
Package Description
10 mg in 1 VIAL, SINGLE-DOSE
Product Code
64538-180
11-Digit Billing Format
64538018000

Clinical Specifications

Proprietary Name
Velmanase Alfa-tycv
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.
Active Ingredient(s)
VELMANASE ALFA-TYCV 10 mg/10mg

Regulatory & Marketing

Labeler Name
Rentschler Biopharma Se
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
03-01-2023
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 64538-180-00 identifies a specific commercial package of 10 mg in 1 vial, single-dose of Velmanase Alfa-tycv (UNFINISHED drug), a bulk ingredient labeled by Rentschler Biopharma Se. This injection, powder, lyophilized, for solution is formulated for 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 Rentschler Biopharma Se on March 01, 2023. The current certification is valid through December 31, 2026.

How is this Rentschler Biopharma Se product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64538018000. 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)
64538-180-00
11-Digit CMS (5-4-2)
64538-0180-00

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