Neomycin And Polymyxin B Sulfates And Hydrocortisone Suspension/ Drops
NDC Package 68071-4229-1

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

Package Information

Neomycin And Polymyxin B Sulfates And Hydrocortisone (neomycin sulfate, polymyxin b sulfate and hydrocortisone) suspension/ dropses is a medication contraindicated in those individuals who have shown hypersensitivity to any of its components, and in herpes simplex, vaccinia, and varicella infections. This formulation utilizes a suspension/ drops delivery system. Marketed by Nucare Pharmaceuticals,inc., this product is identified by NDC 68071-4229 and is authorized under FDA application ANDA064065.

Identification & Billing

NDC Package Code
68071-4229-1
Package Description
10 mL in 1 BOX
Product Code
68071-4229
11-Digit Billing Format
68071422901
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
Non-Proprietary Name
Neomycin Sulfate, Polymyxin B Sulfate And Hydrocortisone
Substance Name
Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate
Dosage Form
Suspension/ Drops - A suspension which is usually administered in a dropwise fashion.
Administration Route
Auricular (otic) - Administration to or by way of the ear.
Active Ingredient(s)
Pharmacologic Class
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
Nucare Pharmaceuticals,inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA064065
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-28-1996
Listing Expiration
12-31-2026
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 68071-4229-1 identifies a specific commercial package of 10 ml in 1 box of Neomycin And Polymyxin B Sulfates And Hydrocortisone, a human prescription drug labeled by Nucare Pharmaceuticals,inc.. This suspension/ drops is formulated for auricular (otic) use and contains hydrocortisone; 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 Nucare Pharmaceuticals,inc. on August 28, 1996. The current certification is valid through December 31, 2026.

How is this Nucare Pharmaceuticals,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071422901. 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)
68071-4229-1
11-Digit CMS (5-4-2)
68071-4229-01

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