Guanfacine Tablet, Extended Release
NDC Package 72162-1801-1

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

Package Information

Guanfacine tablets is guanfacine extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14)]. This formulation utilizes a tablet, extended release delivery system. Marketed by Bryant Ranch Prepack, this product is identified by NDC 72162-1801 and is authorized under FDA application ANDA205689.

Identification & Billing

NDC Package Code
72162-1801-1
Package Description
100 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
72162-1801
11-Digit Billing Format
72162180101
RxNorm Crosswalk
  • RxCUI: 862025 - guanFACINE 4 MG 24HR Extended Release Oral Tablet
  • RxCUI: 862025 - 24 HR guanfacine 4 MG Extended Release Oral Tablet
  • RxCUI: 862025 - guanfacine 4 MG (as guanfacine hydrochloride 4.56 MG) 24 HR Extended Release Oral Tablet
  • RxCUI: 862025 - guanfacine 4 MG (as guanfacine hydrochloride 4.6 MG) 24 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Guanfacine
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 4 mg/1
Pharmacologic Class
Usage Information
Guanfacine extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14)].

Regulatory & Marketing

Labeler Name
Bryant Ranch Prepack
Product Type
Human Prescription Drug
FDA Application #
ANDA205689
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-17-2018
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 72162-1801-1 identifies a specific commercial package of 100 tablet, extended release in 1 bottle of Guanfacine, a human prescription drug labeled by Bryant Ranch Prepack. 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 Bryant Ranch Prepack on August 17, 2018. The current certification is valid through December 31, 2026.

How is this Bryant Ranch Prepack product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72162180101. 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 (5-4-1)
72162-1801-1
11-Digit CMS (5-4-2)
72162-1801-01

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