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  4. NDC Product Code: 0781-5277 Donepezil Hydrochloride

NDC 0781-5277 Donepezil Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0781-5277?
  5. Donepezil Hydrochloride Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Get all the details for National Drug Code (NDC) 0781-5277 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
0781-5277
Proprietary Name:
Donepezil Hydrochloride
Product Type: [3]
Labeler Name: [5]
Sandoz Inc
Labeler Code:
0781
Product Label ID:
6bbb7b73-910b-4664-8856-4c6adbbb48cb
FDA Application Number: [6]
ANDA091198
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
05-10-2011
End Marketing Date: [10]
06-30-2019
Listing Expiration Date: [11]
06-30-2019
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
YELLOW (C48330)
Shape:
ROUND (C48348)
Size(s):
10 MM
Imprint(s):
SZ;265
SZ;266
Score:
1

Code Structure Chart

Product Details

What is NDC 0781-5277?

The NDC code 0781-5277 is assigned by the FDA to the product Donepezil Hydrochloride which is product labeled by Sandoz Inc. The product's dosage form is . The product is distributed in 4 packages with assigned NDC codes 0781-5277-01 100 tablet, orally disintegrating in 1 bottle , 0781-5277-10 1000 tablet, orally disintegrating in 1 bottle , 0781-5277-31 30 tablet, orally disintegrating in 1 bottle , 0781-5277-64 30 tablet, orally disintegrating in 1 blister pack . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Donepezil Hydrochloride?

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.

Which are Donepezil Hydrochloride UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Donepezil Hydrochloride Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

* Please review the disclaimer below.

Patient Education

Donepezil


Donepezil is used to treat dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and may cause changes in mood and personality) in people who have Alzheimer's disease (AD; a brain disease that slowly destroys the memory and the ability to think, learn, communicate and handle daily activities). Donepezil is in a class of medications called cholinesterase inhibitors. It improves mental function (such as memory, attention, the ability to interact with others, speak, think clearly, and perform regular daily activities) by increasing the amount of a certain naturally occurring substance in the brain. Donepezil may improve the ability to think and remember or slow the loss of these abilities in people who have AD. However, donepezil will not cure AD or prevent the loss of mental abilities at some time in the future.
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* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".