Neomycin And Polymyxin B Sulfates, And Bacitracin Zinc
NDC Package 13985-607-03

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 Bacitracin Zinc is neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Marketed by Mwi, this product is identified by NDC 13985-607 and is authorized under FDA application ANDA065088.

Identification & Billing

NDC Package Code
13985-607-03
Package Description
1 TUBE in 1 CARTON / 3.5 g in 1 TUBE
Product Code
13985-607
11-Digit Billing Format
13985060703
RxNorm Crosswalk
  • RxCUI: 308493 - bacitracin zinc 400 UNT / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic Ointment
  • RxCUI: 308493 - bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic Ointment
  • RxCUI: 308493 - bacitracin 0.4 UNT/MG / neomycin 0.35 % / polymyxin B 10 UNT/MG Ophthalmic Ointment
  • RxCUI: 308493 - bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT per GM Ophthalmic Ointment

Clinical Specifications

Proprietary Name
Neomycin And Polymyxin B Sulfates, And Bacitracin Zinc
Dosage Form
-
Usage Information
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP 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
Mwi
FDA Application #
ANDA065088
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-23-2015
Listing Expiration
12-31-2023
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 13985-607-03 identifies a specific commercial package of 1 tube in 1 carton / 3.5 g in 1 tube of Neomycin And Polymyxin B Sulfates, And Bacitracin Zinc, labeled by Mwi. 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 Mwi on March 23, 2015. The current certification is valid through December 31, 2023.

How is this Mwi product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 13985060703. 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)
13985-607-03
11-Digit CMS (5-4-2)
13985-0607-03

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