Turalio
NDC Package 65597-402-28

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Turalio is a medication used to treat a certain type of tumor (tenosynovial giant cell tumor) that is not likely to improve with surgery. Marketed by Daiichi Sankyo Inc., this product is identified by NDC 65597-402 and is authorized under FDA application NDA211810.

Identification & Billing

NDC Package Code
65597-402-28
Package Description
1 BOTTLE in 1 CARTON / 28 CAPSULE in 1 BOTTLE
Product Code
65597-402
11-Digit Billing Format
65597040228
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Turalio
Dosage Form
-
Usage Information
This medication is used to treat a certain type of tumor (tenosynovial giant cell tumor) that is not likely to improve with surgery. Pexidartinib belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of certain tumor cells.

Regulatory & Marketing

Labeler Name
Daiichi Sankyo Inc.
FDA Application #
NDA211810
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-02-2019
End Marketing Date
01-31-2024
Listing Expiration
01-31-2024
Exclude Flag
D
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65597-402). Click a package code to view its specific billing and regulatory data.

65597-402-20
1 BOTTLE in 1 CARTON / 120 CAPSULE in 1 BOTTLE

* 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 65597-402-28 identifies a specific commercial package of 1 bottle in 1 carton / 28 capsule in 1 bottle of Turalio, labeled by Daiichi Sankyo Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Daiichi Sankyo Inc. on August 02, 2019. The current certification is valid through January 31, 2024.

What are the primary indications for this medication?

This medication is used to treat a certain type of tumor (tenosynovial giant cell tumor) that is not likely to improve with surgery. Pexidartinib belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of certain tumor cells.

How is this Daiichi Sankyo Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65597040228. 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)
65597-402-28
11-Digit CMS (5-4-2)
65597-0402-28

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