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  5. NDC Package Code: 63304-926-05 Guanfacine

NDC Package 63304-926-05 Guanfacine

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:
63304-926-05
Package Description:
500 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code:
63304-926
Proprietary Name:
Guanfacine
Non-Proprietary Name:
Guanfacine
Substance Name:
Guanfacine Hydrochloride
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:
63304092605
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:
    Sun Pharmaceutical Industries, 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 HYDROCHLORIDE 3 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:
    ANDA205689
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-17-2018
    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
    63304-926-01100 TABLET, EXTENDED RELEASE in 1 BOTTLE
    63304-926-3030 TABLET, EXTENDED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 63304-926-05?

    The NDC Packaged Code 63304-926-05 is assigned to a package of 500 tablet, extended release in 1 bottle of Guanfacine, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc. The product's dosage form is tablet, extended release and is administered via oral form.

    Is NDC 63304-926 included in the NDC Directory?

    Yes, Guanfacine with product code 63304-926 is active and included in the NDC Directory. The product was first marketed by Sun Pharmaceutical Industries, Inc on August 17, 2018 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 11-digit format for NDC 63304-926-05?

    The 11-digit format is 63304092605. 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
    5-3-263304-926-055-4-263304-0926-05