Memantine Hydrochloride Kit
NDC 0591-3900

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0591-3900?
  5. Memantine Hydrochloride Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

Memantine Hydrochloride is a NDA AUTHORIZED GENERIC-approved product labeled by Actavis Pharma, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a brown kit for oral administration. This product entry covers the primary NDC 0591-3900 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0591-3900
Proprietary Name:
Memantine Hydrochloride
Non-Proprietary Name: [1]
Memantine Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Kit - A packaged collection of related material.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Actavis Pharma, Inc.
Labeler Code:
0591
Product Label ID:
72973b46-f307-4a9e-8fb1-ad2cbccfd736
FDA Application Number: [6]
NDA021487
Marketing Category: [8]
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.

Marketing Timeline

Start Marketing Date: [9]
04-01-2015
End Marketing Date: [10]
08-31-2028
Exclude Flag: [12]
N

Product Characteristics

Color(s):
BROWN (C48332 - TAN)
GRAY (C48324 - GRAY)
Shape:
CAPSULE (C48336)
Size(s):
10 MM
12 MM
Imprint(s):
5;FL
10;FL
Score:
1
Flavor(s):

Code Structure Chart

Product Details

What is NDC 0591-3900?

The NDC code 0591-3900 is assigned by the FDA to the product Memantine Hydrochloride. This pharmaceutical product is labeled by Actavis Pharma, Inc. and is currently categorized as listed product. The medication is a kit administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0591-3900-87. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the Alzheimer's type.

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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: 996561 - memantine HCl 10 MG Oral Tablet
  • RxCUI: 996561 - memantine hydrochloride 10 MG Oral Tablet
  • RxCUI: 996571 - memantine HCl 5 MG Oral Tablet
  • RxCUI: 996571 - memantine hydrochloride 5 MG Oral Tablet
  • RxCUI: 996572 - {21 (memantine hydrochloride 10 MG Oral Tablet) / 28 (memantine hydrochloride 5 MG Oral Tablet) } Pack

* Please review the full disclaimer at the bottom of this page.

Patient Education

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 full disclaimer at the bottom of this page.

Product & Regulatory Definitions
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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".