NDC 0456-1229 Namzaric

Memantine Hydrochloride And Donepezil Hydrochloride Kit Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0456-1229
Proprietary Name:
Namzaric
Non-Proprietary Name: [1]
Memantine Hydrochloride And Donepezil Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Allergan, Inc.
    Labeler Code:
    0456
    FDA Application Number: [6]
    NDA206439
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    11-28-2016
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    GREEN (C48329 - LIGHT)
    BLUE (C48333 - BLUE)
    ORANGE (C48331 - ORANGE)
    Shape:
    CAPSULE (C48336)
    Size(s):
    18 MM
    19 MM
    Imprint(s):
    F;L;14;10
    F;L;28;10
    F;L;7;10
    F;L;21;10
    Score:
    1

    Product Packages

    NDC Code 0456-1229-04

    Package Description: 1 KIT in 1 CARTON * 7 CAPSULE in 1 PACKAGE, COMBINATION * 7 CAPSULE in 1 PACKAGE, COMBINATION * 7 CAPSULE in 1 PACKAGE, COMBINATION * 7 CAPSULE in 1 PACKAGE, COMBINATION

    NDC Code 0456-1229-29

    Package Description: 1 BOX in 1 BOX / 1 CARTON in 1 BOX / 1 KIT in 1 CARTON * 7 CAPSULE in 1 PACKAGE, COMBINATION * 7 CAPSULE in 1 PACKAGE, COMBINATION * 7 CAPSULE in 1 PACKAGE, COMBINATION * 7 CAPSULE in 1 PACKAGE, COMBINATION

    Product Details

    What is NDC 0456-1229?

    The NDC code 0456-1229 is assigned by the FDA to the product Namzaric which is a human prescription drug product labeled by Allergan, Inc.. The generic name of Namzaric is memantine hydrochloride and donepezil hydrochloride. The product's dosage form is kit and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 0456-1229-04 1 kit in 1 carton * 7 capsule in 1 package, combination * 7 capsule in 1 package, combination * 7 capsule in 1 package, combination * 7 capsule in 1 package, combination, 0456-1229-29 1 box in 1 box / 1 carton in 1 box / 1 kit in 1 carton * 7 capsule in 1 package, combination * 7 capsule in 1 package, combination * 7 capsule in 1 package, combination * 7 capsule in 1 package, combination. 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 Namzaric?

    This combination medication is used to treat moderate to severe confusion (dementia) related to Alzheimer's disease. It does not cure Alzheimer's disease, but it may improve memory, awareness, and the ability to perform daily functions. This product contains 2 medications. Memantine works by blocking the action of a certain natural substance in the brain (glutamate) that is believed to be linked to symptoms of Alzheimer's disease. Donepezil is an enzyme blocker that works by restoring the balance of natural substances (neurotransmitters) in the brain.

    Which are Namzaric UNII Codes?

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

    Which are Namzaric 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 Namzaric?

    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: 1599803 - donepezil HCl 10 MG / memantine HCl 28 MG 24HR Extended Release Oral Capsule
    • RxCUI: 1599803 - 24 HR donepezil hydrochloride 10 MG / memantine hydrochloride 28 MG Extended Release Oral Capsule
    • RxCUI: 1599803 - donepezil hydrochloride 10 MG / memantine hydrochloride 28 MG 24 HR Extended Release Oral Capsule
    • RxCUI: 1599805 - donepezil HCl 10 MG / memantine HCl 14 MG 24HR Extended Release Oral Capsule
    • RxCUI: 1599805 - 24 HR donepezil hydrochloride 10 MG / memantine hydrochloride 14 MG Extended Release Oral Capsule

    * 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]


    Memantine


    Memantine is used to treat the symptoms of Alzheimer's disease (AD; a brain disease that slowly destroys the memory and the ability to think, learn, communicate and handle daily activities). Memantine is in a class of medications called NMDA receptor antagonists. It works by decreasing abnormal activity in the brain. Memantine may improve the ability to think and remember or may slow the loss of these abilities in people who have AD. However, memantine will not cure AD or prevent the loss of these 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.

    [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".