Neomycin And Polymyxin B Sulfates, Bacitracin Zinc, And Hydrocortisone
NDC Package 13985-608-03

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, Bacitracin Zinc, And Hydrocortisone is neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Ophthalmic Ointment is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. Marketed by Mwi, this product is identified by NDC 13985-608 and is authorized under FDA application ANDA065213.

Identification & Billing

NDC Package Code
13985-608-03
Package Description
1 TUBE in 1 CARTON / 3.5 g in 1 TUBE
Product Code
13985-608
11-Digit Billing Format
13985060803
RxNorm Crosswalk
  • RxCUI: 1116150 - bacitracin zinc 400 UNT / hydrocortisone acetate 10 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic Ointment
  • RxCUI: 1116150 - bacitracin zinc 0.4 UNT/MG / hydrocortisone acetate 0.01 MG/MG / neomycin sulfate 0.0035 MG/MG / polymyxin B sulfate 10 UNT/MG Ophthalmic Ointment
  • RxCUI: 1116150 - bacitracin zinc 400 UNT/GM / hydrocortisone acetate 1 % / neomycin sulfate 3.5 MG/GM / polymyxin B sulfate 10,000 UNT/GM Ophthalmic Ointment

Clinical Specifications

Proprietary Name
Neomycin And Polymyxin B Sulfates, Bacitracin Zinc, And Hydrocortisone
Dosage Form
-
Usage Information
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Ophthalmic Ointment is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye (see CLINICAL PHARMACOLOGY: Microbiology).The particular anti-infective drugs in this product are active against the following common bacterial eye pathogens: Staphylococcus aureus, streptococci, including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa.The product does not provide adequate coverage against Serratia marcescens.

Regulatory & Marketing

Labeler Name
Mwi
FDA Application #
ANDA065213
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 13985-608-03 identifies a specific commercial package of 1 tube in 1 carton / 3.5 g in 1 tube of Neomycin And Polymyxin B Sulfates, Bacitracin Zinc, And Hydrocortisone, 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: 13985060803. 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)
13985-608-03
11-Digit CMS (5-4-2)
13985-0608-03

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