Intuniv Tablet, Extended Release
NDC Package 54092-515-03

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

Intuniv (guanfacine) tablets is a medication used to treat attention deficit hyperactivity disorder (ADHD), as part of a total treatment plan including psychological, educational, and social measures. This formulation utilizes a tablet, extended release delivery system. Marketed by Takeda Pharmaceuticals America, Inc., this product is identified by NDC 54092-515 and is authorized under FDA application NDA022037.

Identification & Billing

NDC Package Code
54092-515-03
Package Description
7 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
54092-515
11-Digit Billing Format
54092051503
RxNorm Crosswalk
  • RxCUI: 1092566 - {7 (24 HR guanfacine 1 MG Extended Release Oral Tablet) / 7 (24 HR guanfacine 2 MG Extended Release Oral Tablet) } Pack
  • RxCUI: 1092566 - guanFACINE 1 MG 24HR Extended Release Oral Tablet (7) / guanFACINE 2 MG 24HR Extended Release Oral Tablet (7) Pack
  • RxCUI: 1092567 - {7 (24 HR guanfacine 1 MG Extended Release Oral Tablet [Intuniv]) / 7 (24 HR guanfacine 2 MG Extended Release Oral Tablet [Intuniv]) } Pack [Intuniv Kit 7/7]
  • RxCUI: 1092567 - Intuniv Kit 7/7
  • RxCUI: 862006 - guanFACINE 1 MG 24HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Intuniv
Non-Proprietary Name
Guanfacine
Substance Name
Guanfacine Hydrochloride
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
GUANFACINE HYDROCHLORIDE 2 mg/1
Pharmacologic Class
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
Takeda Pharmaceuticals America, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA022037
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-02-2009
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (54092-515). Click a package code to view its specific billing and regulatory data.

54092-515-02
100 TABLET, EXTENDED RELEASE 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 54092-515-03 identifies a specific commercial package of 7 tablet, extended release in 1 bottle of Intuniv, a human prescription drug labeled by Takeda Pharmaceuticals America, Inc.. This tablet, extended release is formulated for oral use and contains guanfacine hydrochloride 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 Takeda Pharmaceuticals America, Inc. on September 02, 2009. The current certification is valid through December 31, 2026.

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 Takeda Pharmaceuticals America, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54092051503. 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)
54092-515-03
11-Digit CMS (5-4-2)
54092-0515-03

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