NDC Package 82950-012-01 Ojemda

Tovorafenib Kit - View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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

Proprietary Name:

Ojemda

Non-Proprietary Name:

Tovorafenib

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).

11-Digit NDC Billing Format:

82950001201

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to RxNorm Crosswalk:

RxCUI: 2682439 - tovorafenib 25 MG in 1 mL Powder for Oral Suspension
RxCUI: 2682439 - tovorafenib 300 MG Powder for Oral Suspension
RxCUI: 2682439 - tovorafenib 25 MG per 1 ML Powder for Oral Suspension
RxCUI: 2682439 - tovorafenib 300 MG per 12 ML Powder for Oral Suspension
RxCUI: 2682445 - ojemda 25 MG in 1 mL Powder for Oral Suspension

Product Type:

Human Prescription Drug

Labeler Name:

Day One Biopharmaceuticals, Inc.

Dosage Form:

Kit - A packaged collection of related material.

Sample Package:

FDA Application Number:

NDA218033

Marketing Category:

NDA - A product marketed under an approved New Drug Application.

Start Marketing Date:

04-30-2024

Listing Expiration Date:

12-31-2026

Exclude Flag:

Code Structure:

82950 - Day One Biopharmaceuticals, Inc.
- 82950-012 - Ojemda
  - 82950-012-01 - 1 KIT in 1 CARTON * 12 mL in 1 BOTTLE, GLASS (82950-112-10)

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 disclaimer below.

Frequently Asked Questions

What is NDC 82950-012-01?

The NDC Packaged Code 82950-012-01 is assigned to a 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.. The product's dosage form is kit and is administered via form.

Is NDC 82950-012 included in the NDC Directory?

Yes, Ojemda with product code 82950-012 is active and included in the NDC Directory. The product was first marketed by Day One Biopharmaceuticals, Inc. on April 30, 2024 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 82950-012-01?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 82950-012-01?

The 11-digit format is 82950001201. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	82950-012-01	5-4-2	82950-0012-01

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