Ivosidenib Powder
NDC Package 54864-720-15

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

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Ivosidenib powders is a medication used to treat a certain type of blood cell cancer (acute myeloid leukemia-AML). This formulation utilizes a powder delivery system. Marketed by Dottikon Exclusive Synthesis Ag, this product is identified by NDC 54864-720.

Identification & Billing

NDC Package Code
54864-720-15
Package Description
20 kg in 1 DRUM
Product Code
54864-720
11-Digit Billing Format
54864072015

Clinical Specifications

Proprietary Name
Ivosidenib
Non-Proprietary Name
Ivosidenib
Substance Name
Ivosidenib
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
IVOSIDENIB 1 kg/kg
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
Dottikon Exclusive Synthesis Ag
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
07-20-2018
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (54864-720). Click a package code to view its specific billing and regulatory data.

54864-720-63
20 kg in 1 DRUM

* 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 54864-720-15 identifies a specific commercial package of 20 kg in 1 drum of Ivosidenib (UNFINISHED drug), a bulk ingredient labeled by Dottikon Exclusive Synthesis Ag. This powder is formulated for 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 Dottikon Exclusive Synthesis Ag on July 20, 2018. 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 Dottikon Exclusive Synthesis Ag product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54864072015. 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)
54864-720-15
11-Digit CMS (5-4-2)
54864-0720-15

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