Ojemda Kit
NDC Package 82950-012-01

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

Package Information

Ojemda (tovorafenib) kits is oJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.This indication is approved under accelerated approval based on response rate and duration of response [see Clinical Studies (14)]. This formulation utilizes a kit delivery system. Marketed by Day One Biopharmaceuticals, Inc., this product is identified by NDC 82950-012 and is authorized under FDA application NDA218033.

Identification & Billing

NDC Package Code
82950-012-01
Package Description
1 KIT in 1 CARTON * 12 mL in 1 BOTTLE, GLASS (82950-112-10)
Product Code
82950-012
11-Digit Billing Format
82950001201
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ojemda
Non-Proprietary Name
Tovorafenib
Dosage Form
Kit - A packaged collection of related material.
Usage Information
OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.This indication is approved under accelerated approval based on response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Regulatory & Marketing

Labeler Name
Day One Biopharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA218033
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-30-2024
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 82950-012-01 identifies a specific commercial package of 1 kit in 1 carton * 12 ml in 1 bottle, glass (82950-112-10) of Ojemda, a human prescription drug labeled by Day One Biopharmaceuticals, Inc.. This kit is formulated for use and contains 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 Day One Biopharmaceuticals, Inc. on April 30, 2024. The current certification is valid through December 31, 2026.

How is this Day One Biopharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82950001201. 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 (5-3-2)
82950-012-01
11-Digit CMS (5-4-2)
82950-0012-01

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