NDC 54868-4768 Guaifenesin And Codeine Phosphate SF

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.
NDC Product Code:
54868-4768
Proprietary Name:
Guaifenesin And Codeine Phosphate SF
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Code:
54868
Start Marketing Date: [9]
04-26-2011
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

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

Code Structure Chart

Product Details

What is NDC 54868-4768?

The NDC code 54868-4768 is assigned by the FDA to the product Guaifenesin And Codeine Phosphate SF which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 54868-4768-0 118 ml in 1 bottle, plastic , 54868-4768-1 473 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 Guaifenesin And Codeine Phosphate SF?

Take every 4 hours do not take more than 6 doses in any 24-hour periodadults and children 12 years and overtake 10 mL (2 tsp)children 6 years to under 12 yearstake 5 mL (1 tsp)children 2 years to under 6 yearsconsult a doctorchildren under 2 yearsdo not useAttention: A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.

Which are Guaifenesin And Codeine Phosphate SF UNII Codes?

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

Which are Guaifenesin And Codeine Phosphate SF 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 And Codeine Phosphate SF?

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.

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".