Voranigo Tablet, Film Coated
NDC Package 72694-879-10

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

Package Information

Voranigo (vorasidenib) tablets is vORANIGO is indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation following surgery including biopsy, sub-total resection, or gross total resection [see Dosage and Administration (2.1), Clinical Pharmacology (12.1) and Clinical Studies (14)]. This formulation utilizes a tablet, film coated delivery system. Marketed by Servier Pharmaceuticals Llc, this product is identified by NDC 72694-879 and is authorized under FDA application NDA218784.

Identification & Billing

NDC Package Code
72694-879-10
Package Description
1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE
Product Code
72694-879
11-Digit Billing Format
72694087910
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Voranigo
Non-Proprietary Name
Vorasidenib
Substance Name
Vorasidenib
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
VORASIDENIB 10 mg/1
Pharmacologic Class
Usage Information
VORANIGO is indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation following surgery including biopsy, sub-total resection, or gross total resection [see Dosage and Administration (2.1), Clinical Pharmacology (12.1) and Clinical Studies (14)].

Regulatory & Marketing

Labeler Name
Servier Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
NDA218784
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-07-2024
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 72694-879-10 identifies a specific commercial package of 1 bottle in 1 carton / 30 tablet, film coated in 1 bottle of Voranigo, a human prescription drug labeled by Servier Pharmaceuticals Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This tablet, film coated is formulated for oral use and contains vorasidenib 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 Servier Pharmaceuticals Llc on August 07, 2024. The current certification is valid through December 31, 2027.

How is this Servier Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72694087910. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
72694-879-10
11-Digit CMS (5-4-2)
72694-0879-10

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