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  5. NDC Package Code: 0591-0444-01 Guanfacine

NDC Package 0591-0444-01 Guanfacine

Tablet 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:
0591-0444-01
Package Description:
100 TABLET in 1 BOTTLE, PLASTIC
Product Code:
0591-0444
Proprietary Name:
Guanfacine
Non-Proprietary Name:
Guanfacine
Substance Name:
Guanfacine Hydrochloride
Usage Information:
Guanfacine tablets, USP are indicated in the management of hypertension. Guanfacine tablets, USP may be given alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.
11-Digit NDC Billing Format:
00591044401
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:
    Actavis Pharma, Inc.
    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
  • 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:
    ANDA074145
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-17-1995
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0591-0444-0077000 TABLET in 1 BAG

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0591-0444-01?

    The NDC Packaged Code 0591-0444-01 is assigned to a package of 100 tablet in 1 bottle, plastic of Guanfacine, a human prescription drug labeled by Actavis Pharma, Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 0591-0444 included in the NDC Directory?

    Yes, Guanfacine with product code 0591-0444 is active and included in the NDC Directory. The product was first marketed by Actavis Pharma, Inc. on October 17, 1995 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 0591-0444-01?

    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 0591-0444-01?

    The 11-digit format is 00591044401. 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 4-4-2 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
    4-4-20591-0444-015-4-200591-0444-01