Taliglucerase Alfa Liquid
NDC Package 50210-249-01

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.

Taliglucerase Alfa liquids is taliglucerase is used to treat a certain rare genetic problem (Gaucher disease). This formulation utilizes a liquid delivery system. Marketed by Protalix Ltd, this product is identified by NDC 50210-249.

Identification & Billing

NDC Package Code
50210-249-01
Package Description
2 L in 1 BOTTLE, PLASTIC
Product Code
50210-249
11-Digit Billing Format
50210024901

Clinical Specifications

Proprietary Name
Taliglucerase Alfa
Non-Proprietary Name
Taliglucerase Alfa
Substance Name
Taliglucerase Alfa
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Active Ingredient(s)
TALIGLUCERASE ALFA 1750 g/2L
Usage Information
Taliglucerase is used to treat a certain rare genetic problem (Gaucher disease). Taliglucerase replaces a certain natural substance (an enzyme called glucocerebrosidase) that is missing in people with Gaucher disease. This medication improves blood, bone, liver, and spleen problems caused by Gaucher disease. Taliglucerase does not correct the genetic problem, and treatment must be continued for life.

Regulatory & Marketing

Labeler Name
Protalix Ltd
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
05-01-2012
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 50210-249-01 identifies a specific commercial package of 2 l in 1 bottle, plastic of Taliglucerase Alfa (UNFINISHED drug), drug for further processing labeled by Protalix Ltd. This liquid is formulated for use and contains taliglucerase alfa 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 Protalix Ltd on May 01, 2012. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Taliglucerase is used to treat a certain rare genetic problem (Gaucher disease). Taliglucerase replaces a certain natural substance (an enzyme called glucocerebrosidase) that is missing in people with Gaucher disease. This medication improves blood, bone, liver, and spleen problems caused by Gaucher disease. Taliglucerase does not correct the genetic problem, and treatment must be continued for life.

How is this Protalix Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50210024901. 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)
50210-249-01
11-Digit CMS (5-4-2)
50210-0249-01

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