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  4. NDC Product Code: 63943-4683 Dexchlorpheniramine Maleate

NDC 63943-4683 Dexchlorpheniramine Maleate

Concentrate - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 63943-4683?
  4. Dexchlorpheniramine Maleate Uses
  5. Active Ingredients

Product Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.
NDC Product Code:
63943-4683
Proprietary Name:
Dexchlorpheniramine Maleate
Non-Proprietary Name: [1]
Dexchlorpheniramine Maleate
Substance Name: [2]
Dexchlorpheniramine Maleate
NDC Directory Status:
Bulk Ingredient
Product Type: [3]
UNFINISHED PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Concentrate - A liquid preparation of increased strength and reduced volume which is usually diluted prior to administration.
Labeler Name: [5]
Keshava Organics Pvt Ltd
Labeler Code:
63943
Marketing Category: [8]
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date: [9]
10-17-2000
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
N
Unfinished Product: [13]
Yes
Code Navigator:

Code Structure Chart

Product Details

What is NDC 63943-4683?

The NDC code 63943-4683 is assigned by the FDA to the UNFINISHED product Dexchlorpheniramine Maleate which is a bulk ingredient product labeled by Keshava Organics Pvt Ltd. The generic name of Dexchlorpheniramine Maleate is dexchlorpheniramine maleate. The product's dosage form is concentrate. The product is distributed in a single package with assigned NDC code 63943-4683-1 25 kg in 1 drum . 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 Dexchlorpheniramine Maleate?

Dexchlorpheniramine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms may 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. It also blocks another natural substance made by your body (acetylcholine). Blocking acetylcholine helps lessen 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. 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 medications that 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).

What are Dexchlorpheniramine Maleate 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.

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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.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[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".

[13] What is an Unfinished Product? - This field indicates if the product is an unfinished drug. An unfinished drug is an active pharmaceutical ingredient either alone or with other ingredients that is not a finished drug product. Unfinished drugs are used to process other drugs or for drug compounding.