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  5. NDC Package Code: 71209-019-01 Donepezil Hydrochloride

NDC Package 71209-019-01 Donepezil Hydrochloride

Tablet, Film Coated 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:
71209-019-01
Package Description:
30 TABLET, FILM COATED in 1 BOTTLE
Product Code:
71209-019
Proprietary Name:
Donepezil Hydrochloride
Non-Proprietary Name:
Donepezil Hydrochloride
Substance Name:
Donepezil Hydrochloride
Usage Information:
Donepezil Hydrochloride Tablets 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:
71209001901
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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Cadila Pharmaceuticals Limited
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DONEPEZIL HYDROCHLORIDE 5 mg/1
    • Pharmacologic Class(es):
  • Cholinesterase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Cholinesterase Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA204609
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-30-2017
    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
    71209-019-0490 TABLET, FILM COATED in 1 BOTTLE
    71209-019-111000 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 71209-019-01?

    The NDC Packaged Code 71209-019-01 is assigned to a package of 30 tablet, film coated in 1 bottle of Donepezil Hydrochloride, a human prescription drug labeled by Cadila Pharmaceuticals Limited. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 71209-019 included in the NDC Directory?

    Yes, Donepezil Hydrochloride with product code 71209-019 is active and included in the NDC Directory. The product was first marketed by Cadila Pharmaceuticals Limited on January 30, 2017 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 71209-019-01?

    The 11-digit format is 71209001901. 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
    5-3-271209-019-015-4-271209-0019-01