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  5. NDC Package Code: 68554-5038-2 Donepezil Hydrochloride

NDC Package 68554-5038-2 Donepezil Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:
68554-5038-2
Package Description:
100 TABLET, FILM COATED in 1 BOTTLE
Product Code:
68554-5038
Proprietary Name:
Donepezil Hydrochloride
Usage Information:
Donepezil hydrochloride tablet USP is indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.
11-Digit NDC Billing Format:
68554503802
NDC to RxNorm Crosswalk:
  • RxCUI: 997223 - donepezil HCl 10 MG Oral Tablet
  • RxCUI: 997223 - donepezil hydrochloride 10 MG Oral Tablet
  • RxCUI: 997229 - donepezil HCl 5 MG Oral Tablet
  • RxCUI: 997229 - donepezil hydrochloride 5 MG Oral Tablet
    • Labeler Name:
    Hetero Labs Limited
    Sample Package:
    No
    Start Marketing Date:
    09-02-2014
    Listing Expiration Date:
    12-31-2020
    Exclude Flag:
    I
    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
    68554-5038-030 TABLET, FILM COATED in 1 BOTTLE
    68554-5038-190 TABLET, FILM COATED in 1 BOTTLE
    68554-5038-3500 TABLET, FILM COATED in 1 BOTTLE
    68554-5038-410 TABLET, FILM COATED in 1 CARTON

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 68554-5038-2?

    The NDC Packaged Code 68554-5038-2 is assigned to a package of 100 tablet, film coated in 1 bottle of Donepezil Hydrochloride, labeled by Hetero Labs Limited. The product's dosage form is and is administered via form.

    Is NDC 68554-5038 included in the NDC Directory?

    No, Donepezil Hydrochloride with product code 68554-5038 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Hetero Labs Limited on September 02, 2014 and its listing in the NDC Directory is set to expire on December 31, 2020 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 68554-5038-2?

    The 11-digit format is 68554503802. 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 5-4-1 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
    5-4-168554-5038-25-4-268554-5038-02