NDC 13985-744 Neomycin And Polymyxin B Sulfates And Dexamethasone

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:
13985-744
Proprietary Name:
Neomycin And Polymyxin B Sulfates And Dexamethasone
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Mwi
Labeler Code:
13985
Start Marketing Date: [9]
07-25-1994
Listing Expiration Date: [11]
12-31-2021
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 13985-744-35

Package Description: 1 TUBE in 1 CARTON / 3.5 g in 1 TUBE

Product Details

What is NDC 13985-744?

The NDC code 13985-744 is assigned by the FDA to the product Neomycin And Polymyxin B Sulfates And Dexamethasone which is product labeled by Mwi. The product's dosage form is . The product is distributed in a single package with assigned NDC code 13985-744-35 1 tube in 1 carton / 3.5 g in 1 tube. 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 Neomycin And Polymyxin B Sulfates And Dexamethasone?

For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies.The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa.This product does not provide adequate coverage against: Serratia marcescens and Streptococci, including Streptococcus pneumoniae.

Which are Neomycin And Polymyxin B Sulfates And Dexamethasone UNII Codes?

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

Which are Neomycin And Polymyxin B Sulfates And Dexamethasone 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 Neomycin And Polymyxin B Sulfates And Dexamethasone?

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: 309679 - dexAMETHasone 1 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic Ointment
  • RxCUI: 309679 - dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic Ointment
  • RxCUI: 309679 - dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic Ointment

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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".