Kesimpta Injection, Solution
NDC 0078-1007

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 0078-1007?
  4. Kesimpta 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

Kesimpta (ofatumumab) is a BLA-approved product labeled by Novartis Pharmaceuticals Corporation. Ofatumumab is used to treat a certain type of cancer (chronic lymphocytic leukemia - CLL). It is supplied as a injection, solution for subcutaneous administration. This product entry covers the primary NDC 0078-1007 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

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
Code Navigator:

Clinical Specifications

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 & Regulatory Data

Labeler Name: [5]
Novartis Pharmaceuticals Corporation
Labeler Code:
0078
Product Label ID:
6a8a3f53-2062-48ff-9dbe-b939df133ca3
FDA Application Number: [6]
BLA125326
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.

Marketing Timeline

Start Marketing Date: [9]
10-26-2009
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 0078-1007?

The NDC code 0078-1007 is assigned by the FDA to the product Kesimpta. It is commonly known by its generic name, ofatumumab. This pharmaceutical product is labeled by Novartis Pharmaceuticals Corporation and is currently categorized as listed product. The medication is a injection, solution administered via subcutaneous route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 0078-1007-68, 0078-1007-98. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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 Active Ingredients of this product?

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 the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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 of this product?

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.

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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 full disclaimer at the bottom of this page.

Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".