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  5. NDC Package Code: 25682-007-01 Kanuma

NDC Package 25682-007-01 Kanuma

Sebelipase Alfa Injection, 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:
25682-007-01
Package Description:
1 VIAL, GLASS in 1 CARTON / 10 mL in 1 VIAL, GLASS
Product Code:
25682-007
Proprietary Name:
Kanuma
Non-Proprietary Name:
Sebelipase Alfa
Substance Name:
Sebelipase Alfa
Usage Information:
KANUMA® is indicated for the treatment of patients with a diagnosis of Lysosomal Acid Lipase (LAL) deficiency.
11-Digit NDC Billing Format:
25682000701
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1726979 - sebelipase alfa 20 MG in 10 ML Injection
  • RxCUI: 1726979 - 10 ML sebelipase alfa 2 MG/ML Injection
  • RxCUI: 1726979 - sebelipase alfa 20 MG per 10 ML Injection
  • RxCUI: 1726984 - Kanuma 20 MG in 10 ML Injection
  • RxCUI: 1726984 - 10 ML sebelipase alfa 2 MG/ML Injection [Kanuma]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Alexion Pharmaceuticals, Inc.
    Dosage Form:
    Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • SEBELIPASE ALFA 2 mg/mL
    • Pharmacologic Class(es):
  • Hydrolytic Lysosomal Cholesteryl Ester-specific Enzyme - [EPC] (Established Pharmacologic Class)
  • Hydrolytic Lysosomal Triacylglycerol-specific Enzyme - [EPC] (Established Pharmacologic Class)
  • Sterol Esterase - [CS]
    • Sample Package:
    No
    FDA Application Number:
    BLA125561
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    12-08-2015
    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 25682-007-01 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    25682000701J2840Injection, sebelipase alfa1 MG1012020

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 25682-007-01?

    The NDC Packaged Code 25682-007-01 is assigned to a package of 1 vial, glass in 1 carton / 10 ml in 1 vial, glass of Kanuma, a human prescription drug labeled by Alexion Pharmaceuticals, Inc.. The product's dosage form is injection, solution, concentrate and is administered via intravenous form.

    Is NDC 25682-007 included in the NDC Directory?

    Yes, Kanuma with product code 25682-007 is active and included in the NDC Directory. The product was first marketed by Alexion Pharmaceuticals, Inc. on December 08, 2015 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 25682-007-01?

    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 25682-007-01?

    The 11-digit format is 25682000701. 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
    5-3-225682-007-015-4-225682-0007-01