Neomycin And Polymyxin B Sulfates And Hydrocortisone
NDC Package 53002-9060-1

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 Hydrocortisone is for the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics. Marketed by Rpk Pharmaceuticals, Inc., this product is identified by NDC 53002-9060 and is authorized under FDA application ANDA062423.

Identification & Billing

NDC Package Code
53002-9060-1
Package Description
10 mL in 1 BOTTLE
Product Code
53002-9060
11-Digit Billing Format
53002906001
RxNorm Crosswalk
  • RxCUI: 204423 - neomycin sulfate 0.35 % / polymyxin B sulfate 10,000 UNT/ML / hydrocortisone 1 % Otic Solution
  • RxCUI: 204423 - hydrocortisone 10 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Otic Solution
  • RxCUI: 204423 - hydrocortisone 1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML Otic Solution
  • RxCUI: 204423 - hydrocortisone 10 MG / neomycin 3.5 MG / polymyxin B 10,000 UNT per ML Otic Solution

Clinical Specifications

Proprietary Name
Neomycin And Polymyxin B Sulfates And Hydrocortisone
Dosage Form
-
Usage Information
For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics.

Regulatory & Marketing

Labeler Name
Rpk Pharmaceuticals, Inc.
FDA Application #
ANDA062423
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-18-2003
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 53002-9060-1 identifies a specific commercial package of 10 ml in 1 bottle of Neomycin And Polymyxin B Sulfates And Hydrocortisone, labeled by Rpk Pharmaceuticals, Inc.. 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 Rpk Pharmaceuticals, Inc. on March 18, 2003. The current certification is valid through December 31, 2024.

How is this Rpk Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53002906001. 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 (5-4-1)
53002-9060-1
11-Digit CMS (5-4-2)
53002-9060-01

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