Tibsovo Tablet, Film Coated
NDC Package 72694-617-60

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

Package Information

Tibsovo (ivosidenib) tablets is a medication used to treat a certain type of blood cell cancer (acute myeloid leukemia-AML). This formulation utilizes a tablet, film coated delivery system. Marketed by Servier Pharmaceutical Llc, this product is identified by NDC 72694-617 and is authorized under FDA application NDA211192.

Identification & Billing

NDC Package Code
72694-617-60
Package Description
1 BOTTLE in 1 CARTON / 60 TABLET, FILM COATED in 1 BOTTLE
Product Code
72694-617
11-Digit Billing Format
72694061760
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
Tibsovo
Non-Proprietary Name
Ivosidenib
Substance Name
Ivosidenib
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)
IVOSIDENIB 250 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat a certain type of blood cell cancer (acute myeloid leukemia-AML). Ivosidenib works by helping your bone marrow grow normal blood cells so you will need fewer blood transfusions.

Regulatory & Marketing

Labeler Name
Servier Pharmaceutical Llc
Product Type
Human Prescription Drug
FDA Application #
NDA211192
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-19-2021
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 72694-617-60 identifies a specific commercial package of 1 bottle in 1 carton / 60 tablet, film coated in 1 bottle of Tibsovo, a human prescription drug labeled by Servier Pharmaceutical 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 ivosidenib 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 Pharmaceutical Llc on October 19, 2021. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat a certain type of blood cell cancer (acute myeloid leukemia-AML). Ivosidenib works by helping your bone marrow grow normal blood cells so you will need fewer blood transfusions.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72694061760. 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)
72694-617-60
11-Digit CMS (5-4-2)
72694-0617-60

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