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  5. NDC Package Code: 24979-538-01 Guanfacine Extended-release

NDC Package 24979-538-01 Guanfacine Extended-release

Tablet, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
24979-538-01
Package Description:
100 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code:
24979-538
Proprietary Name:
Guanfacine Extended-release
Non-Proprietary Name:
Guanfacine
Substance Name:
Guanfacine
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) ].
11-Digit NDC Billing Format:
24979053801
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 862006 - guanFACINE 1 MG 24HR Extended Release Oral Tablet
  • RxCUI: 862006 - 24 HR guanfacine 1 MG Extended Release Oral Tablet
  • RxCUI: 862006 - guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral Tablet
  • RxCUI: 862006 - guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral Tablet
  • RxCUI: 862013 - guanFACINE 2 MG 24HR Extended Release Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Twi Pharmaceuticals, Inc.
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • GUANFACINE 4 mg/1
    • Pharmacologic Class(es):
  • Adrenergic alpha2-Agonists - [MoA] (Mechanism of Action)
  • Central alpha-2 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA201408
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-07-2017
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    24979-538-101000 TABLET, EXTENDED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 24979-538-01?

    The NDC Packaged Code 24979-538-01 is assigned to a package of 100 tablet, extended release in 1 bottle of Guanfacine Extended-release, a human prescription drug labeled by Twi Pharmaceuticals, Inc.. The product's dosage form is tablet, extended release and is administered via oral form.

    Is NDC 24979-538 included in the NDC Directory?

    Yes, Guanfacine Extended-release with product code 24979-538 is active and included in the NDC Directory. The product was first marketed by Twi Pharmaceuticals, Inc. on July 07, 2017 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 24979-538-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 100.

    What is the 11-digit format for NDC 24979-538-01?

    The 11-digit format is 24979053801. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-224979-538-015-4-224979-0538-01