NDC 68554-5038 Donepezil Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
68554-5038
Proprietary Name:
Donepezil Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Hetero Labs Limited
Labeler Code:
68554
Start Marketing Date: [9]
09-02-2014
Listing Expiration Date: [11]
12-31-2020
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
7 MM
9 MM
Imprint(s):
24;I
21;I
Score:
1

Product Packages

NDC Code 68554-5038-0

Package Description: 30 TABLET, FILM COATED in 1 BOTTLE

NDC Code 68554-5038-1

Package Description: 90 TABLET, FILM COATED in 1 BOTTLE

NDC Code 68554-5038-2

Package Description: 100 TABLET, FILM COATED in 1 BOTTLE

NDC Code 68554-5038-3

Package Description: 500 TABLET, FILM COATED in 1 BOTTLE

NDC Code 68554-5038-4

Package Description: 10 TABLET, FILM COATED in 1 CARTON

Product Details

What is NDC 68554-5038?

The NDC code 68554-5038 is assigned by the FDA to the product Donepezil Hydrochloride which is product labeled by Hetero Labs Limited. The product's dosage form is . The product is distributed in 5 packages with assigned NDC codes 68554-5038-0 30 tablet, film coated in 1 bottle , 68554-5038-1 90 tablet, film coated in 1 bottle , 68554-5038-2 100 tablet, film coated in 1 bottle , 68554-5038-3 500 tablet, film coated in 1 bottle , 68554-5038-4 10 tablet, film coated in 1 carton . 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 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.

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:

What is the NDC to RxNorm Crosswalk for Donepezil Hydrochloride?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Product Footnotes

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

[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.

[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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".