NDC 54932-208 Codeine Phosphate And Guaifenesin

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.

Get all the details for National Drug Code (NDC) 54932-208 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
54932-208
Proprietary Name:
Codeine Phosphate And Guaifenesin
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Labeler Code:
54932
FDA Application Number: [6]
part341
Marketing Category: [8]
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date: [9]
01-17-2017
Listing Expiration Date: [11]
12-31-2021
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
RED (C48326)
Flavor(s):
CHERRY (C73375)

Code Structure Chart

Product Details

What is NDC 54932-208?

The NDC code 54932-208 is assigned by the FDA to the product Codeine Phosphate And Guaifenesin which is product labeled by Bioramo, Llc. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 54932-208-81 473 ml in 1 bottle, plastic , 54932-208-85 118 ml in 1 bottle, plastic , 54932-208-86 237 ml 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 Codeine Phosphate And Guaifenesin?

Do not exceed 6 doses in 24 hoursAdults and children 12 years of age and over:2 tsp (10 mL) every 4 hours, or as directed by a doctor.Children 6 to under 12 years of age:1 tsp (5 mL) every 4 hours, or as directed by a doctor.Children under 6 years of age:Consult a doctor.

Which are Codeine Phosphate And Guaifenesin UNII Codes?

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

Which are Codeine Phosphate And Guaifenesin 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 Codeine Phosphate And Guaifenesin?

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: 995868 - codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral Solution
  • RxCUI: 995868 - codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral Solution
  • RxCUI: 995868 - codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral Solution

* Please review the disclaimer below.

Patient Education

Codeine


Codeine is used to relieve mild to moderate pain. It is also used, usually in combination with other medications, to reduce coughing. Codeine will help relieve symptoms but will not treat the cause of symptoms or speed recovery. Codeine belongs to a class of medications called opiate (narcotic) analgesics and to a class of medications called antitussives. When codeine is used to treat pain, it works by changing the way the brain and nervous system respond to pain. When codeine is used to reduce coughing, it works by decreasing the activity in the part of the brain that causes coughing. Codeine is also available in combination with acetaminophen (Capital and Codeine, Tylenol with Codeine), aspirin, carisoprodol, and promethazine and as an ingredient in many cough and cold medications. This monograph only includes information about the use of codeine. If you are taking a codeine combination product, be sure to read information about all the ingredients in the product you are taking and ask your doctor or pharmacist for more information.
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Guaifenesin


Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
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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.

[6] 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.

[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, 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".