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  5. NDC Package Code: 53746-711-01 Guanfacine Hydrochloride

NDC Package 53746-711-01 Guanfacine Hydrochloride

Guanfacine Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
53746-711-01
Package Description:
100 TABLET in 1 BOTTLE
Product Code:
53746-711
Proprietary Name:
Guanfacine Hydrochloride
Non-Proprietary Name:
Guanfacine
Substance Name:
Guanfacine Hydrochloride
Usage Information:
Guanfacine tablets are indicated in the management of hypertension. Guanfacine may be given alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.
11-Digit NDC Billing Format:
53746071101
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: 197745 - guanFACINE HCl 1 MG Oral Tablet
  • RxCUI: 197745 - guanfacine 1 MG Oral Tablet
  • RxCUI: 197745 - guanfacine 1 MG (as guanfacine HCl 1.15 MG) Oral Tablet
  • RxCUI: 197746 - guanFACINE HCl 2 MG Oral Tablet
  • RxCUI: 197746 - guanfacine 2 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amneal Pharmaceuticals Of New York Llc
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • GUANFACINE HYDROCHLORIDE 1 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:
    ANDA075109
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-15-2022
    Listing Expiration Date:
    12-31-2024
    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.

    Frequently Asked Questions

    What is NDC 53746-711-01?

    The NDC Packaged Code 53746-711-01 is assigned to a package of 100 tablet in 1 bottle of Guanfacine Hydrochloride, a human prescription drug labeled by Amneal Pharmaceuticals Of New York Llc. The product's dosage form is tablet and is administered via oral form.

    Is NDC 53746-711 included in the NDC Directory?

    Yes, Guanfacine Hydrochloride with product code 53746-711 is active and included in the NDC Directory. The product was first marketed by Amneal Pharmaceuticals Of New York Llc on April 15, 2022 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 53746-711-01?

    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 53746-711-01?

    The 11-digit format is 53746071101. 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
    5-3-253746-711-015-4-253746-0711-01