NDC 51655-425 Clemastine Fumarate

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:
51655-425
Proprietary Name:
Clemastine Fumarate
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Northwind Pharmaceuticals, Llc
Labeler Code:
51655
Start Marketing Date: [9]
04-28-2014
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
10 MM
Imprint(s):
93;308
Score:
1

Product Packages

NDC Code 51655-425-04

Package Description: 4 TABLET in 1 BOTTLE, DISPENSING

Product Details

What is NDC 51655-425?

The NDC code 51655-425 is assigned by the FDA to the product Clemastine Fumarate which is product labeled by Northwind Pharmaceuticals, Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 51655-425-04 4 tablet in 1 bottle, dispensing . 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 Clemastine Fumarate?

Clemastine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms include rash, watery eyes, itchy eyes/nose/throat/skin, cough, runny nose, and sneezing. This medication works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. By blocking another natural substance made by your body (acetylcholine), it helps dry up some body fluids to relieve symptoms such as watery eyes and runny nose. Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

Which are Clemastine Fumarate UNII Codes?

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

What is the NDC to RxNorm Crosswalk for Clemastine Fumarate?

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".