NDC 54838-222 Memantine 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:
54838-222
Proprietary Name:
Memantine Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Silarx Pharmaceuticals, Inc.
Labeler Code:
54838
Start Marketing Date: [9]
11-10-2016
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330 - BEIGE)
GRAY (C48324)
Shape:
OVAL (C48345)
Size(s):
10 MM
12 MM
Imprint(s):
SI;101
SI;102
Score:
1

Product Packages

NDC Code 54838-222-06

Package Description: 60 TABLET in 1 BOTTLE, PLASTIC

NDC Code 54838-222-13

Package Description: 1000 TABLET in 1 BOTTLE, PLASTIC

NDC Code 54838-222-52

Package Description: 500 TABLET in 1 BOTTLE, PLASTIC

Product Details

What is NDC 54838-222?

The NDC code 54838-222 is assigned by the FDA to the product Memantine Hydrochloride which is product labeled by Silarx Pharmaceuticals, Inc.. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 54838-222-06 60 tablet in 1 bottle, plastic , 54838-222-13 1000 tablet in 1 bottle, plastic , 54838-222-52 500 tablet in 1 bottle, plastic . 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 Memantine Hydrochloride?

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

Which are Memantine Hydrochloride UNII Codes?

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

Which are Memantine 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 Memantine 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:

* 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.

[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".