Elelyso Injection, Powder, Lyophilized, For Solution
NDC Package 0069-0106-01

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

Package Information

Elelyso (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 Pfizer Laboratories Div Pfizer Inc, this product is identified by NDC 0069-0106 and is authorized under FDA application BLA022458.

Identification & Billing

NDC Package Code
0069-0106-01
Package Description
1 VIAL, GLASS in 1 CARTON / 5 mL in 1 VIAL, GLASS
Product Code
0069-0106
11-Digit Billing Format
00069010601
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Elelyso
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.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
TALIGLUCERASE ALFA 200 U/5mL
Pharmacologic Class
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
Pfizer Laboratories Div Pfizer Inc
Product Type
Human Prescription Drug
FDA Application #
BLA022458
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
05-01-2012
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 0069-0106-01 identifies a specific commercial package of 1 vial, glass in 1 carton / 5 ml in 1 vial, glass of Elelyso, a human prescription drug labeled by Pfizer Laboratories Div Pfizer Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, lyophilized, for solution is formulated for intravenous 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 Pfizer Laboratories Div Pfizer Inc 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 Pfizer Laboratories Div Pfizer Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00069010601. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
0069-0106-01
11-Digit CMS (5-4-2)
00069-0106-01

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