Neomycin And Polymyxin B Sulfates And Gramicidin
NDC Package 21695-528-10

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 Gramicidin is ophthalmic Solution is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Marketed by Rebel Distributors Corp, this product is identified by NDC 21695-528 and is authorized under FDA application ANDA064047.

Identification & Billing

NDC Package Code
21695-528-10
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER
Product Code
21695-528
11-Digit Billing Format
21695052810
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 310594 - gramicidin 0.025 MG / neomycin sulfate 1.75 MG / polymyxin B sulfate 10,000 UNT per ML Ophthalmic Solution
  • RxCUI: 310594 - gramicidin 0.025 MG/ML / neomycin 1.75 MG/ML / polymyxin B 10000 UNT/ML Ophthalmic Solution
  • RxCUI: 310594 - gramicidin 0.025 MG / neomycin (as neomycin sulfate) 1.75 MG / polymyxin B (as polymyxin B sulfate) 10,000 UNT per ML Ophthalmic Solution

Clinical Specifications

Proprietary Name
Neomycin And Polymyxin B Sulfates And Gramicidin
Dosage Form
-
Usage Information
Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.

Regulatory & Marketing

Labeler Name
Rebel Distributors Corp
FDA Application #
ANDA064047
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-31-1996
Listing Expiration
12-31-2017
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 21695-528-10 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 10 ml in 1 bottle, dropper of Neomycin And Polymyxin B Sulfates And Gramicidin, labeled by Rebel Distributors Corp. 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 Rebel Distributors Corp on January 31, 1996. The current certification is valid through December 31, 2017.

How is this Rebel Distributors Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21695052810. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
21695-528-10
11-Digit CMS (5-4-2)
21695-0528-10

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