NDC 0078-1007 Kesimpta

Ofatumumab Injection, Solution Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0078-1007
Proprietary Name:
Kesimpta
Non-Proprietary Name: [1]
Ofatumumab
Substance Name: [2]
Ofatumumab
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s): [4]
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Labeler Name: [5]
    Novartis Pharmaceuticals Corporation
    Labeler Code:
    0078
    FDA Application Number: [6]
    BLA125326
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    10-26-2009
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Packages

    NDC Code 0078-1007-68

    Package Description: 1 SYRINGE, GLASS in 1 CARTON / .4 mL in 1 SYRINGE, GLASS

    NDC Code 0078-1007-98

    Package Description: 1 SYRINGE, GLASS in 1 CARTON / .4 mL in 1 SYRINGE, GLASS

    Product Details

    What is NDC 0078-1007?

    The NDC code 0078-1007 is assigned by the FDA to the product Kesimpta which is a human prescription drug product labeled by Novartis Pharmaceuticals Corporation. The generic name of Kesimpta is ofatumumab. The product's dosage form is injection, solution and is administered via subcutaneous form. The product is distributed in 2 packages with assigned NDC codes 0078-1007-68 1 syringe, glass in 1 carton / .4 ml in 1 syringe, glass, 0078-1007-98 1 syringe, glass in 1 carton / .4 ml in 1 syringe, glass. 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 Kesimpta?

    Ofatumumab is used to treat a certain type of cancer (chronic lymphocytic leukemia - CLL). Ofatumumab belongs to a class of drugs known as monoclonal antibodies. This medication works by stopping the growth of cancer cells.

    What are Kesimpta 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.

    Which are Kesimpta UNII Codes?

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

    Which are Kesimpta 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 Kesimpta?

    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 Kesimpta?

    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

    Ofatumumab Injection (Chronic Lymphocytic Leukemia)


    Ofatumumab injection is used to treat chronic lymphocytic leukemia (CLL; a type of cancer of the white blood cells): in combination with chlorambucil in people who have not received treatment or are unable to receive treatment with fludarabine (Fludara). in combination with fludarabine (Fludara) and alemtuzumab (Campath) when CLL has returned after previous treatment. as extended treatment in people with CLL that has improved fully or partially after at least two lines of treatment. in people who have not responded to treatment with fludarabine (Fludara) and alemtuzumab (Campath). Ofatumumab injection is in a class of medications called monoclonal antibodies. It works by killing cancer cells. Ofatumumab is also available as an injection (Kesimpta) that is used to treat 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). This monograph only gives information about ofatumumab injection (Arzerra) for treatment of chronic lymphocytic leukemia. If you are receiving ofatumumab for multiple sclerosis, read the monograph entitled Ofatumumab Injection (Multiple Sclerosis).
    [Learn More]


    Ofatumumab Injection (Multiple Sclerosis)


    Ofatumumab injection is used to prevent episodes of symptoms and slow the worsening of disability in adults who have relapsing 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), including: clinically isolated syndrome (CIS; first nerve symptom episode that lasts at least 24 hours), relapsing-remitting disease (course of disease where symptoms flare up from time to time), and active secondary progressive disease (later stage of disease with continuous worsening of symptoms). Ofatumumab is in a class of medications called monoclonal antibodies. It works by stopping certain cells of the immune system from reaching the brain and spinal cord and causing damage. Ofatumumab is also available as an injection (Arzerra) 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 ofatumumab injection (Kesimpta) for multiple sclerosis. If you are receiving ofatumumab for chronic lymphocytic leukemia, read the monograph entitled Ofatumumab 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".