Kesimpta Injection, Solution
NDC Package 0078-1007-68

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Kesimpta (ofatumumab) injection is ofatumumab is used to treat a certain type of cancer (chronic lymphocytic leukemia - CLL). This formulation utilizes a injection, solution delivery system. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-1007 and is authorized under FDA application BLA125326.

Identification & Billing

NDC Package Code
0078-1007-68
Package Description
1 SYRINGE, GLASS in 1 CARTON / .4 mL in 1 SYRINGE, GLASS
Product Code
0078-1007
11-Digit Billing Format
00078100768
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Kesimpta
Non-Proprietary Name
Ofatumumab
Substance Name
Ofatumumab
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
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
OFATUMUMAB 20 mg/.4mL
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Novartis Pharmaceuticals Corporation
Product Type
Human Prescription Drug
FDA Application #
BLA125326
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
10-26-2009
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0078-1007). Click a package code to view its specific billing and regulatory data.

0078-1007-98
1 SYRINGE, GLASS in 1 CARTON / .4 mL in 1 SYRINGE, GLASS

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0078-1007-68 identifies a specific commercial package of 1 syringe, glass in 1 carton / .4 ml in 1 syringe, glass of Kesimpta, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. This injection, solution is formulated for subcutaneous use and contains ofatumumab as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Novartis Pharmaceuticals Corporation on October 26, 2009. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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.

How is this Novartis Pharmaceuticals Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078100768. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0078-1007-68
11-Digit CMS (5-4-2)
00078-1007-68

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.