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  5. NDC Package Code: 58468-0357-1 Campath

NDC Package 58468-0357-1 Campath

Alemtuzumab Injection Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    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:
58468-0357-1
Package Description:
1 VIAL, SINGLE-USE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-USE
Product Code:
58468-0357
Proprietary Name:
Campath
Non-Proprietary Name:
Alemtuzumab
Substance Name:
Alemtuzumab
Usage Information:
Alemtuzumab is used to treat multiple sclerosis (MS). It is not a cure for MS but it is thought to help by preventing immune system cells (lymphocytes) from attacking the nerves in your brain and spinal cord. It helps decrease the number of relapses and may prevent or delay disability.
11-Digit NDC Billing Format:
58468035701
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 828265 - alemtuzumab 30 MG in 1 ML Injection
  • RxCUI: 828265 - 1 ML alemtuzumab 30 MG/ML Injection
  • RxCUI: 828265 - alemtuzumab 30 MG per 1 ML Injection
  • RxCUI: 828267 - Campath 30 MG in 1 ML Injection
  • RxCUI: 828267 - 1 ML alemtuzumab 30 MG/ML Injection [Campath]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Genzyme Corporation
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • ALEMTUZUMAB 30 mg/mL
    • Pharmacologic Class(es):
  • CD52-directed Antibody Interactions - [MoA] (Mechanism of Action)
  • CD52-directed Cytolytic Antibody - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    BLA103948
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    11-30-2009
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    58468-0357-33 VIAL, SINGLE-USE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-USE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 58468-0357-1?

    The NDC Packaged Code 58468-0357-1 is assigned to a package of 1 vial, single-use in 1 carton / 1 ml in 1 vial, single-use of Campath, a human prescription drug labeled by Genzyme Corporation. The product's dosage form is injection and is administered via intravenous form.

    Is NDC 58468-0357 included in the NDC Directory?

    Yes, Campath with product code 58468-0357 is active and included in the NDC Directory. The product was first marketed by Genzyme Corporation on November 30, 2009 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 58468-0357-1?

    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 58468-0357-1?

    The 11-digit format is 58468035701. 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 5-4-1 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
    5-4-158468-0357-15-4-258468-0357-01