NDC Package 68382-347-01 Donepezil Hydrochloride

Tablet, Orally Disintegrating Oral - View Billable Units, 11-Digit Format, RxNorm

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:
68382-347-01
Package Description:
100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
Product Code:
Proprietary Name:
Donepezil Hydrochloride
Non-Proprietary Name:
Donepezil Hydrochloride
Substance Name:
Donepezil Hydrochloride
Usage Information:
Donepezil hydrochloride orally disintegrating tablets are 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:
68382034701
NDC to RxNorm Crosswalk:
  • RxCUI: 997220 - donepezil HCl 10 MG Disintegrating Oral Tablet
  • RxCUI: 997220 - donepezil hydrochloride 10 MG Disintegrating Oral Tablet
  • RxCUI: 997226 - donepezil HCl 5 MG Disintegrating Oral Tablet
  • RxCUI: 997226 - donepezil hydrochloride 5 MG Disintegrating Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Zydus Pharmaceuticals Usa Inc.
    Dosage Form:
    Tablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA090175
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-11-2011
    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
    68382-347-05500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
    68382-347-0630 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
    68382-347-101000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
    68382-347-1690 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
    68382-347-77100 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-347-30)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 68382-347-01?

    The NDC Packaged Code 68382-347-01 is assigned to a package of 100 tablet, orally disintegrating in 1 bottle of Donepezil Hydrochloride, a human prescription drug labeled by Zydus Pharmaceuticals Usa Inc.. The product's dosage form is tablet, orally disintegrating and is administered via oral form.

    Is NDC 68382-347 included in the NDC Directory?

    Yes, Donepezil Hydrochloride with product code 68382-347 is active and included in the NDC Directory. The product was first marketed by Zydus Pharmaceuticals Usa Inc. on May 11, 2011 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 68382-347-01?

    The 11-digit format is 68382034701. 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
    5-3-268382-347-015-4-268382-0347-01