Intuniv
NDC Package 54092-521-01

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

Package Information

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

Intuniv is a medication used to treat attention deficit hyperactivity disorder (ADHD), as part of a total treatment plan including psychological, educational, and social measures. Marketed by Shire Us Manufacturing Inc., this product is identified by NDC 54092-521 and is authorized under FDA application NDA022037.

Identification & Billing

NDC Package Code
54092-521-01
Package Description
1 KIT in 1 KIT
Product Code
54092-521
11-Digit Billing Format
54092052101

Clinical Specifications

Proprietary Name
Intuniv
Dosage Form
-
Usage Information
This medication is used to treat attention deficit hyperactivity disorder (ADHD), as part of a total treatment plan including psychological, educational, and social measures. Unlike other drugs used to treat ADHD, guanfacine is not a stimulant. The exact way that guanfacine works to treat ADHD is unknown. Guanfacine is thought to affect receptors in the parts of the brain that lead to strengthening working memory, reducing distraction, and improving attention and impulse control. Guanfacine may help lessen ADHD symptoms such as being disruptive, inattentive, hyperactive, impulsive, and arguing with adults or losing one's temper.

Regulatory & Marketing

Labeler Name
Shire Us Manufacturing Inc.
FDA Application #
NDA022037
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-02-2009
End Marketing Date
09-10-2013
Listing Expiration
09-10-2013
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 54092-521-01 identifies a specific commercial package of 1 kit in 1 kit of Intuniv, labeled by Shire Us Manufacturing Inc.. 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 Shire Us Manufacturing Inc. on September 02, 2009. The current certification is valid through September 10, 2013.

What are the primary indications for this medication?

This medication is used to treat attention deficit hyperactivity disorder (ADHD), as part of a total treatment plan including psychological, educational, and social measures. Unlike other drugs used to treat ADHD, guanfacine is not a stimulant. The exact way that guanfacine works to treat ADHD is unknown. Guanfacine is thought to affect receptors in the parts of the brain that lead to strengthening working memory, reducing distraction, and improving attention and impulse control. Guanfacine may help lessen ADHD symptoms such as being disruptive, inattentive, hyperactive, impulsive, and arguing with adults or losing one's temper.

How is this Shire Us Manufacturing Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54092052101. 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)
54092-521-01
11-Digit CMS (5-4-2)
54092-0521-01

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