Neomycin Polymyxin B Sulfates And Dexamethasone
NDC Package 45865-796-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

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

Neomycin Polymyxin B Sulfates And Dexamethasone is 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 corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. Marketed by Medsource Pharmaceuticals, this product is identified by NDC 45865-796 and is authorized under FDA application ANDA064135.

Identification & Billing

NDC Package Code
45865-796-01
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER
Product Code
45865-796
11-Digit Billing Format
45865079601
RxNorm Crosswalk
  • RxCUI: 309680 - neomycin sulfate 3.5 MG/ML / polymyxin B sulfate 10,000 UNT/mL / dexAMETHasone 0.1 % Ophthalmic Suspension
  • RxCUI: 309680 - dexamethasone 1 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Ophthalmic Suspension
  • RxCUI: 309680 - dexamethasone 0.1 % / neomycin 0.35 % / polymyxin B 10,000 UNT per ML Ophthalmic Suspension

Clinical Specifications

Proprietary Name
Neomycin Polymyxin B Sulfates And Dexamethasone
Dosage Form
-
Usage Information
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 corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids 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.

Regulatory & Marketing

Labeler Name
Medsource Pharmaceuticals
FDA Application #
ANDA064135
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-13-1995
Listing Expiration
12-31-2024
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 45865-796-01 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 5 ml in 1 bottle, dropper of Neomycin Polymyxin B Sulfates And Dexamethasone, labeled by Medsource Pharmaceuticals. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Medsource Pharmaceuticals on September 13, 1995. The current certification is valid through December 31, 2024.

How is this Medsource Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45865079601. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
45865-796-01
11-Digit CMS (5-4-2)
45865-0796-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.