Neomycin And Polymyxin B Sulfates And Hydrocortisone
NDC Package 52959-084-00

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 a medication contraindicated in those individuals who have shown hypersensitivity to any of its components, and in herpes simplex, vaccinia, and varicella infections. Marketed by H.j. Harkins Company, Inc., this product is identified by NDC 52959-084 and is authorized under FDA application ANDA064065.

Identification & Billing

NDC Package Code
52959-084-00
Package Description
10 mL in 1 BOTTLE, DROPPER
Product Code
52959-084
11-Digit Billing Format
52959008400
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
10 ML
RxNorm Crosswalk
  • RxCUI: 310687 - hydrocortisone 10 MG (1 % ) / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per mL Otic Suspension
  • RxCUI: 310687 - hydrocortisone 10 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Otic Suspension
  • RxCUI: 310687 - hydrocortisone 10 MG / neomycin 3.5 MG / polymyxin B 10,000 UNT per 1 ML Otic Suspension

Clinical Specifications

Proprietary Name
Neomycin And Polymyxin B Sulfates And Hydrocortisone
Dosage Form
-
Usage Information
This product is contraindicated in those individuals who have shown hypersensitivity to any of its components, and in herpes simplex, vaccinia, and varicella infections.

Regulatory & Marketing

Labeler Name
H.j. Harkins Company, Inc.
FDA Application #
ANDA064065
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-28-1996
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 52959-084-00 identifies a specific commercial package of 10 ml in 1 bottle, dropper of Neomycin And Polymyxin B Sulfates And Hydrocortisone, labeled by H.j. Harkins Company, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 10 billable units per package. 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 H.j. Harkins Company, Inc. on August 28, 1996. The current certification is valid through December 31, 2017.

How is this H.j. Harkins Company, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52959008400. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 10 total billable units per package. 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)
52959-084-00
11-Digit CMS (5-4-2)
52959-0084-00

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