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  5. NDC Package Code: 54092-700-01 Elaprase

NDC Package 54092-700-01 Elaprase

Idursulfase Solution, Concentrate 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:
54092-700-01
Package Description:
1 VIAL, GLASS in 1 BOX / 3 mL in 1 VIAL, GLASS
Product Code:
54092-700
Proprietary Name:
Elaprase
Non-Proprietary Name:
Idursulfase
Substance Name:
Idursulfase
Usage Information:
ELAPRASE is indicated for patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). ELAPRASE has been shown to improve walking capacity in patients 5 years and older.In patients 16 months to 5 years of age, no data are available to demonstrate improvement in disease-related symptoms or long term clinical outcome; however, treatment with ELAPRASE has reduced spleen volume similarly to that of adults and children 5 years of age and older.The safety and efficacy of ELAPRASE have not been established in pediatric patients less than 16 months of age [see Use in Specific Populations (8.4)].
11-Digit NDC Billing Format:
54092070001
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 644104 - idursulfase 6 MG in 3 ML Injection
  • RxCUI: 644104 - 3 ML idursulfase 2 MG/ML Injection
  • RxCUI: 644104 - idursulfase 6 MG per 3 ML Injection
  • RxCUI: 647118 - elaprase 6 MG in 3 ML Injection
  • RxCUI: 647118 - 3 ML idursulfase 2 MG/ML Injection [Elaprase]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Takeda Pharmaceuticals America, Inc.
    Dosage Form:
    Solution, Concentrate - A liquid preparation (i.e., a substance that flows readily in its natural state) that contains a drug dissolved in a suitable solvent or mixture of mutually miscible solvents; the drug has been strengthened by the evaporation of its nonactive parts.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • IDURSULFASE 6 mg/3mL
    • Pharmacologic Class(es):
  • Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme - [EPC] (Established Pharmacologic Class)
  • alpha-Glucosidases - [CS]
    • Sample Package:
    No
    FDA Application Number:
    BLA125151
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    07-24-2006
    Listing Expiration Date:
    12-31-2024
    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 54092-700-01 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    54092070001J1743Idursulfase injection1 MG3166

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 54092-700-01?

    The NDC Packaged Code 54092-700-01 is assigned to a package of 1 vial, glass in 1 box / 3 ml in 1 vial, glass of Elaprase, a human prescription drug labeled by Takeda Pharmaceuticals America, Inc.. The product's dosage form is solution, concentrate and is administered via intravenous form.

    Is NDC 54092-700 included in the NDC Directory?

    Yes, Elaprase with product code 54092-700 is active and included in the NDC Directory. The product was first marketed by Takeda Pharmaceuticals America, Inc. on July 24, 2006 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 54092-700-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 54092-700-01?

    The 11-digit format is 54092070001. 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 5-3-2 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
    5-3-254092-700-015-4-254092-0700-01