Neomycin And Polymyxin B Sulfates And Dexamethasone
NDC Package 61919-113-35

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 And Polymyxin B Sulfates And Dexamethasone is for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or 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 conjunctivitises is accepted to obtain a diminution in edema and inflammation. Marketed by Direct Rx, this product is identified by NDC 61919-113 and is authorized under FDA application ANDA062938.

Identification & Billing

NDC Package Code
61919-113-35
Package Description
3.5 g in 1 CARTON
Product Code
61919-113
11-Digit Billing Format
61919011335
RxNorm Crosswalk
  • 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

Clinical Specifications

Proprietary Name
Neomycin And 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 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 conjunctivitises 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 drugs in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilusinfluenzae, Klebsiella/Enterobacterspecies, Niesseriaspecies, and Pseudomonas aeruginosa.This product does not provide adequate coverage against: Serratiamarcescensand Streptococci, including Streptococcus pneumoniae.

Regulatory & Marketing

Labeler Name
Direct Rx
FDA Application #
ANDA062938
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-17-2017
Listing Expiration
12-31-2022
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 61919-113-35 identifies a specific commercial package of 3.5 g in 1 carton of Neomycin And Polymyxin B Sulfates And Dexamethasone, labeled by Direct Rx. 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 Direct Rx on March 17, 2017. The current certification is valid through December 31, 2022.

How is this Direct Rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61919011335. 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)
61919-113-35
11-Digit CMS (5-4-2)
61919-0113-35

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