Nourianz Tablet, Film Coated
NDC Package 42747-604-07

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

Nourianz (istradefylline) tablets is istradefylline is used by people with Parkinson's disease taking carbidopa/levodopa to reduce the amount of "off" time (periods of slow movement or stiffness). This formulation utilizes a tablet, film coated delivery system. Marketed by Kyowa Kirin, Inc., this product is identified by NDC 42747-604 and is authorized under FDA application NDA022075.

Identification & Billing

NDC Package Code
42747-604-07
Package Description
1 BLISTER PACK in 1 BOX / 7 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
42747-604
11-Digit Billing Format
42747060407
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nourianz
Non-Proprietary Name
Istradefylline
Substance Name
Istradefylline
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)
ISTRADEFYLLINE 40 mg/1
Usage Information
Istradefylline is used by people with Parkinson's disease taking carbidopa/levodopa to reduce the amount of "off" time (periods of slow movement or stiffness).

Regulatory & Marketing

Labeler Name
Kyowa Kirin, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA022075
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-27-2019
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

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 (42747-604). Click a package code to view its specific billing and regulatory data.

42747-604-90
90 TABLET, FILM COATED 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 42747-604-07 identifies a specific commercial package of 1 blister pack in 1 box / 7 tablet, film coated in 1 blister pack of Nourianz, a human prescription drug labeled by Kyowa Kirin, Inc.. This tablet, film coated is formulated for oral use and contains istradefylline 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 Kyowa Kirin, Inc. on August 27, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Istradefylline is used by people with Parkinson's disease taking carbidopa/levodopa to reduce the amount of "off" time (periods of slow movement or stiffness).

How is this Kyowa Kirin, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42747060407. 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)
42747-604-07
11-Digit CMS (5-4-2)
42747-0604-07

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