NDC 68382-346 Donepezil Hydrochloride

Tablet, Orally Disintegrating Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
68382-346
Proprietary Name:
Donepezil Hydrochloride
Non-Proprietary Name: [1]
Donepezil Hydrochloride
Substance Name: [2]
Donepezil Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Zydus Pharmaceuticals Usa Inc.
    Labeler Code:
    68382
    FDA Application Number: [6]
    ANDA090175
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    05-11-2011
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325 - WHITE TO OFF WHITE)
    Shape:
    ROUND (C48348)
    Size(s):
    7 MM
    Imprint(s):
    ZF;14
    Score:
    1
    Flavor(s):
    PEPPERMINT (C73408 - FLAVOR PEPPERMINT)
    STRAWBERRY (C73417 - FLAVOR STRAWBERRY)

    Product Packages

    NDC Code 68382-346-01

    Package Description: 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE

    NDC Code 68382-346-05

    Package Description: 500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE

    NDC Code 68382-346-06

    Package Description: 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE

    Price per Unit: $0.23250 per EA

    NDC Code 68382-346-10

    Package Description: 1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE

    NDC Code 68382-346-16

    Package Description: 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE

    NDC Code 68382-346-77

    Package Description: 100 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-346-30)

    Product Details

    What is NDC 68382-346?

    The NDC code 68382-346 is assigned by the FDA to the product Donepezil Hydrochloride which is a human prescription drug product labeled by Zydus Pharmaceuticals Usa Inc.. The product's dosage form is tablet, orally disintegrating and is administered via oral form. The product is distributed in 6 packages with assigned NDC codes 68382-346-01 100 tablet, orally disintegrating in 1 bottle , 68382-346-05 500 tablet, orally disintegrating in 1 bottle , 68382-346-06 30 tablet, orally disintegrating in 1 bottle , 68382-346-10 1000 tablet, orally disintegrating in 1 bottle , 68382-346-16 90 tablet, orally disintegrating in 1 bottle , 68382-346-77 100 blister pack in 1 carton / 1 tablet, orally disintegrating in 1 blister pack (68382-346-30). 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.

    What are Donepezil Hydrochloride Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • DONEPEZIL HYDROCHLORIDE 5 mg/1 - An indan and piperidine derivative that acts as a selective and reversible inhibitor of ACETYLCHOLINESTERASE. Donepezil is highly selective for the central nervous system and is used in the management of mild to moderate DEMENTIA in ALZHEIMER 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:
    • 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

    Which are the Pharmacologic Classes for Donepezil Hydrochloride?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * 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.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [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.

    [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".