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  4. NDC Product Code: 50383-063 Guaifenesin

NDC 50383-063 Guaifenesin

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 50383-063?
  5. Guaifenesin Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
50383-063
Proprietary Name:
Guaifenesin
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Akorn
Labeler Code:
50383
Product Label ID:
5cb704a7-301c-494e-948f-872ee0d5a289
Start Marketing Date: [9]
03-07-2012
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Flavor(s):
CHERRY (C73375 - ARTIFICIAL CHERRY FLAVOR)
VANILLA (C73421 - ARTIFICIAL VANILLA FLAVOR)

Product Packages

NDC Code 50383-063-07

Package Description: 10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE

NDC Code 50383-063-12

Package Description: 10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE

NDC Code 50383-063-18

Package Description: 10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE

Product Details

What is NDC 50383-063?

The NDC code 50383-063 is assigned by the FDA to the product Guaifenesin which is product labeled by Akorn. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 50383-063-07 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 ml in 1 cup, unit-dose, 50383-063-12 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 10 ml in 1 cup, unit-dose, 50383-063-18 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 15 ml in 1 cup, unit-dose. 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 Guaifenesin?

Follow dosage below or use as directed by a physician.do not take more than 6 doses in any 24-hour periodagedoseadults and children 12 years and over10 to 20 mL (2 to 4 teaspoonfuls) every 4 hourschildren 6 years to under 12 years5 to 10 mL (1 to 2 teaspoonfuls) every 4 hourschildren 2 to under 6 years of age2.5 to 5 mL (1/2 to 1 teaspoonful) every 4 hourschildren under 2 years of ageask a doctorHow Supplied:Guaifenesin Oral Solution is a clear viscous liquid with a slight cherry odor supplied in the following oral dosage forms: 5 mL unit dose, 10 mL unit dose, 15 mL unit dose in trays of 10 and 4 fl. oz. (118 mL) bottlePhenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)

Which are Guaifenesin UNII Codes?

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

Which are 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 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:

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Patient Education

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.

[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".