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  5. NDC Package Code: 0069-0106-01 Elelyso

NDC Package 0069-0106-01 Elelyso

Taliglucerase Alfa Injection, Powder, Lyophilized, For Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0069-0106-01
Package Description:
1 VIAL, GLASS in 1 CARTON / 5 mL in 1 VIAL, GLASS
Product Code:
0069-0106
Proprietary Name:
Elelyso
Non-Proprietary Name:
Taliglucerase Alfa
Substance Name:
Taliglucerase Alfa
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.
11-Digit NDC Billing Format:
00069010601
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1292879 - taliglucerase alfa 200 UNT Injection
  • RxCUI: 1292881 - Elelyso 200 UNT Injection
  • RxCUI: 1292881 - taliglucerase alfa 200 UNT Injection [Elelyso]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Pfizer Laboratories Div Pfizer Inc
    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(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • TALIGLUCERASE ALFA 200 U/5mL
    • Pharmacologic Class(es):
  • Glucosylceramidase - [CS]
  • Hydrolytic Lysosomal Glucocerebroside-specific Enzyme - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    BLA022458
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    05-01-2012
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 0069-0106-01 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    00069010601J3060Inj, taliglucerase alfa 10 u10 units112020

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0069-0106-01?

    The NDC Packaged Code 0069-0106-01 is assigned to a 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. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 0069-0106 included in the NDC Directory?

    Yes, Elelyso with product code 0069-0106 is active and included in the NDC Directory. The product was first marketed by Pfizer Laboratories Div Pfizer Inc on May 01, 2012 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0069-0106-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 0069-0106-01?

    The 11-digit format is 00069010601. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20069-0106-015-4-200069-0106-01