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  4. NDC Product Code: 63824-553 Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride

NDC 63824-553 Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride

Tablet, Coated - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 63824-553?
  4. 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:
63824-553
Proprietary Name:
Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride
Non-Proprietary Name: [1]
Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride
Substance Name: [2]
Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride
NDC Directory Status:
Drug For Further Processing
Product Type: [3]
UNFINISHED PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Labeler Name: [5]
Rb Health (us) Llc
Labeler Code:
63824
Marketing Category: [8]
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date: [9]
03-15-2013
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Unfinished Product: [13]
Yes
Code Structure:
Code Navigator:

Product Packages

NDC Code 63824-553-90

Package Description: 13574 TABLET, COATED in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK

NDC Code 63824-553-99

Package Description: 12441 TABLET, COATED in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK

Product Details

What is NDC 63824-553?

The NDC code 63824-553 is assigned by the FDA to the UNFINISHED product Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride which is drug for further processing product labeled by Rb Health (us) Llc. The generic name of Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride is dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride. The product's dosage form is tablet, coated. The product is distributed in 2 packages with assigned NDC codes 63824-553-90 13574 tablet, coated in 1 container, flexible intermediate bulk , 63824-553-99 12441 tablet, coated in 1 container, flexible intermediate bulk . 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 Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride 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.
  • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 - Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.
  • GUAIFENESIN 200 mg/1 - An expectorant that also has some muscle relaxing action. It is used in many cough preparations.
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 - An alpha-1 adrenergic agonist used as a mydriatic, nasal decongestant, and cardiotonic agent.

* 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.

[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.