Neomycin Polymyxin B Sulfates And Dexamethasone Suspension/ Drops
NDC Package 72189-320-05

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

Package Information

Neomycin Polymyxin B Sulfates And Dexamethasone (neomycin sulfate, polymyxin b sulfate and dexamethasone suspension/ drops) suspension/ dropses is 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 corticosteroids use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. This formulation utilizes a suspension/ drops delivery system. Marketed by Directrx, this product is identified by NDC 72189-320 and is authorized under FDA application ANDA064135.

Identification & Billing

NDC Package Code
72189-320-05
Package Description
5 mL in 1 BOTTLE
Product Code
72189-320
11-Digit Billing Format
72189032005
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
Non-Proprietary Name
Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone Suspension/ Drops
Substance Name
Dexamethasone; Neomycin Sulfate; Polymyxin B Sulfate
Dosage Form
Suspension/ Drops - A suspension which is usually administered in a dropwise fashion.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
Pharmacologic Class
Usage Information
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 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
Directrx
Product Type
Human Prescription Drug
FDA Application #
ANDA064135
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-18-2022
Listing Expiration
12-31-2026
Exclude Flag
N
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 72189-320-05 identifies a specific commercial package of 5 ml in 1 bottle of Neomycin Polymyxin B Sulfates And Dexamethasone, a human prescription drug labeled by Directrx. This suspension/ drops is formulated for topical use and contains dexamethasone; neomycin sulfate; polymyxin b sulfate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Directrx on January 18, 2022. The current certification is valid through December 31, 2026.

How is this Directrx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72189032005. 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)
72189-320-05
11-Digit CMS (5-4-2)
72189-0320-05

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