Neomycin And Polymyxin B Sulfates, Bacitracin Zinc, And Hydrocortisone
NDC 13985-608

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 13985-608?
  4. Neomycin And Polymyxin B Sulfates, Bacitracin Zinc, And Hydrocortisone Uses
  5. Active Ingredients UNII Codes
  6. Inactive 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.

Neomycin And Polymyxin B Sulfates, Bacitracin Zinc, And Hydrocortisone is a ANDA-approved product labeled by Mwi. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 13985-608 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
13985-608
Proprietary Name:
Neomycin And Polymyxin B Sulfates, Bacitracin Zinc, And Hydrocortisone
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Mwi
Labeler Code:
13985
Product Label ID:
f914f577-32aa-4b7a-9996-ca24b34f022d
FDA Application Number: [6]
ANDA065213
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
03-23-2015
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I

Code Structure Chart

Product Details

What is NDC 13985-608?

The NDC code 13985-608 is assigned by the FDA to the product Neomycin And Polymyxin B Sulfates, Bacitracin Zinc, And Hydrocortisone. This pharmaceutical product is labeled by Mwi 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: 13985-608-03. 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?

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Ophthalmic Ointment is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of corticosteroid 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 (see CLINICAL PHARMACOLOGY: Microbiology).The particular anti-infective drugs in this product are active against the following common bacterial eye pathogens: Staphylococcus aureus, streptococci, including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa.The product does not provide adequate coverage against Serratia marcescens.

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 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: 1116150 - bacitracin zinc 400 UNT / hydrocortisone acetate 10 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic Ointment
  • RxCUI: 1116150 - bacitracin zinc 0.4 UNT/MG / hydrocortisone acetate 0.01 MG/MG / neomycin sulfate 0.0035 MG/MG / polymyxin B sulfate 10 UNT/MG Ophthalmic Ointment
  • RxCUI: 1116150 - bacitracin zinc 400 UNT/GM / hydrocortisone acetate 1 % / neomycin sulfate 3.5 MG/GM / polymyxin B sulfate 10,000 UNT/GM Ophthalmic Ointment

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

Patient Education

Neomycin, Polymyxin, Bacitracin, and Hydrocortisone Ophthalmic


Neomycin, polymyxin, bacitracin, and hydrocortisone ophthalmic combination is used to treat and prevent eye infections caused by certain bacteria and to reduce the irritation, redness, burning, and swelling of eye inflammation caused by infection, chemicals, heat, radiation, foreign bodies in the eye, and other eye conditions. Neomycin, polymyxin, and bacitracin are in a class of medications called antibiotics. They work by stopping the growth of bacteria. Hydrocortisone is in a class of medications called corticosteroids. It works by activating natural substances in the eye to reduce swelling, redness, and itching.
[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".