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NDC 58468-0357 Campath

Alemtuzumab Injection Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 58468-0357?
  4. Campath Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes
  10. Patient Education

Product Information

NDC Product Code:
58468-0357
Proprietary Name:
Campath
Non-Proprietary Name: [1]
Alemtuzumab
Substance Name: [2]
Alemtuzumab
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s): [4]
  • Intravenous - Administration within or into a vein or veins.
    • Labeler Name: [5]
    Genzyme Corporation
    Labeler Code:
    58468
    Product Label ID:
    4f5f7255-7abc-4328-bd1a-ceaf139ef3e0
    FDA Application Number: [6]
    BLA103948
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    11-30-2009
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 58468-0357-1

    Package Description: 1 VIAL, SINGLE-USE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-USE

    NDC Code 58468-0357-3

    Package Description: 3 VIAL, SINGLE-USE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-USE

    Product Details

    What is NDC 58468-0357?

    The NDC code 58468-0357 is assigned by the FDA to the product Campath which is a human prescription drug product labeled by Genzyme Corporation. The generic name of Campath is alemtuzumab. The product's dosage form is injection and is administered via intravenous form. The product is distributed in 2 packages with assigned NDC codes 58468-0357-1 1 vial, single-use in 1 carton / 1 ml in 1 vial, single-use, 58468-0357-3 3 vial, single-use in 1 carton / 1 ml in 1 vial, single-use. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Campath?

    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.

    What are Campath Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • ALEMTUZUMAB 30 mg/mL - An anti-CD52 ANTIGEN monoclonal antibody used for the treatment of certain types of CD52-positive lymphomas (e.g., CHRONIC LYMPHOCYTIC LEUKEMIA; CUTANEOUS T-CELL LYMPHOMA; and T-CELL LYMPHOMA). Its mode of actions include ANTIBODY-DEPENDENT CELL CYTOTOXICITY.

    Which are Campath UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Campath Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Campath?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

    Which are the Pharmacologic Classes for Campath?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Alemtuzumab Injection (Chronic Lymphocytic Leukemia)


    Alemtuzumab injection is used to treat B-cell chronic lymphocytic leukemia (B-CLL; a slowly developing cancer in which too many of a certain type of white blood cell accumulate in the body). Alemtuzumab is in a class of medications called monoclonal antibodies. It works by activating the immune system to destroy cancer cells. Alemtuzumab is also available as an injection (Lemtrada) that is used to treat multiple sclerosis (a disease in which the nerves do not function properly; you may experience weakness, numbness, loss of muscle coordination and problems with vision, speech, and bladder control). This monograph only gives information about alemtuzumab injection (Campath) for B-CLL. If you are receiving alemtuzumab for multiple sclerosis, read the monograph entitled Alemtuzumab Injection (Multiple Sclerosis).
    [Learn More]


    Alemtuzumab Injection (Multiple Sclerosis)


    Alemtuzumab injection is used to treat adults with various forms of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control) who have not improved with at least two or more MS medications including: relapsing-remitting forms (course of disease where symptoms flare up from time to time) or secondary progressive forms (course of disease where relapses occur more often). Alemtuzumab is in a class of medications called monoclonal antibodies. It works by decreasing the action of immune cells that may cause nerve damage. Alemtuzumab is also available as an injection (Campath) that is used to treat chronic lymphocytic leukemia (a slowly developing cancer in which too many of a certain type of white blood cell accumulates in the body). This monograph only gives information about alemtuzumab injection (Lemtrada) for multiple sclerosis. If you are receiving alemtuzumab for chronic lymphocytic leukemia, read the monograph entitled Alemtuzumab Injection (Chronic Lymphocytic Leukemia).
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".