Taliglucerase Alfa Injection, Powder, Lyophilized, For Solution
NDC Package 0009-0106-01

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 injection is taliglucerase is used to treat a certain rare genetic problem (Gaucher disease). This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Pharmacia And Upjohn Company Llc, this product is identified by NDC 0009-0106.

Identification & Billing

NDC Package Code
0009-0106-01
Package Description
48 VIAL, GLASS in 1 CONTAINER / 5 mL in 1 VIAL, GLASS
Product Code
0009-0106
11-Digit Billing Format
00009010601

Clinical Specifications

Proprietary Name
Taliglucerase Alfa
Non-Proprietary Name
Taliglucerase Alfa
Substance Name
Taliglucerase Alfa
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)
TALIGLUCERASE ALFA 200 U/5mL
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
Pharmacia And Upjohn Company Llc
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 0009-0106-01 identifies a specific commercial package of 48 vial, glass in 1 container / 5 ml in 1 vial, glass of Taliglucerase Alfa (UNFINISHED drug), drug for further processing labeled by Pharmacia And Upjohn Company Llc. This injection, powder, lyophilized, for solution 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 Pharmacia And Upjohn Company Llc 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 Pharmacia And Upjohn Company Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00009010601. 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 (4-4-2)
0009-0106-01
11-Digit CMS (5-4-2)
00009-0106-01

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