Rydex
NDC 23359-023

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 23359-023?
  5. Rydex Uses
  6. Active Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Rydex is a OTC MONOGRAPH FINAL-approved product labeled by Centurion Labs. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 23359-023 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
23359-023
Proprietary Name:
Rydex
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Centurion Labs
Labeler Code:
23359
Product Label ID:
9751b120-49d4-46dd-82cc-638412b5f86d
FDA Application Number: [6]
part341
Marketing Category: [8]
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.

Marketing Timeline

Start Marketing Date: [9]
05-14-2010
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I

Product Characteristics

Flavor(s):

Code Structure Chart

Product Details

What is NDC 23359-023?

The NDC code 23359-023 is assigned by the FDA to the product Rydex. This pharmaceutical product is labeled by Centurion Labs and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 23359-023-16. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Do not exceed recommended dosage.Adults and children 12 years of ageand over:3 teaspoonfuls (15 mL) every 4 to 6 hours, not to exceed 18 teaspoonfuls in a 24 hour period.Children 6 to under 12 years of age:1 1/2 teaspoonfuls (7.5 mL) every 4 to 6 hours, not to exceed 9 teaspoonfuls in a 24 hour period.Not recommended for children under 6 years of age.

Which are the associated UNII Codes?

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

What is the NDC to RxNorm Crosswalk for this product?

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: 994289 - codeine phosphate 6.33 MG / brompheniramine maleate 1.33 MG / pseudoephedrine HCl 10 MG in 5 mL Oral Solution
  • RxCUI: 994289 - brompheniramine maleate 0.27 MG/ML / codeine phosphate 1.27 MG/ML / pseudoephedrine hydrochloride 2 MG/ML Oral Solution
  • RxCUI: 994289 - brompheniramine maleate 1.33 MG / codeine phosphate 6.33 MG / pseudoephedrine hydrochloride 10 MG per 5 ML Oral Solution

* Please review the full disclaimer at the bottom of this page.

Patient Education

Brompheniramine


Brompheniramine relieves red, irritated, itchy, watery eyes; sneezing; and runny nose caused by allergies, hay fever, and the common cold. Brompheniramine helps control symptoms, but does not treat the cause of the symptoms or speed recovery. Brompheniramine should not be used to cause sleepiness in children. Brompheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
[Learn More]


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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Pseudoephedrine


Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.
[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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".