Bacitracin Zinc And Polymyxin B Sulfate
NDC Package 0168-0273-38

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.

Bacitracin Zinc And Polymyxin B Sulfate is ophthalmic Ointment is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Marketed by E. Fougera & Co., A Division Of Nycomed Us Inc., this product is identified by NDC 0168-0273 and is authorized under FDA application ANDA065022.

Identification & Billing

NDC Package Code
0168-0273-38
Package Description
3.5 g in 1 TUBE
Product Code
0168-0273
11-Digit Billing Format
00168027338
RxNorm Crosswalk
  • RxCUI: 308511 - bacitracin zinc 500 UNT / polymyxin B sulfate 10,000 UNT per GM Ophthalmic Ointment
  • RxCUI: 308511 - bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Ophthalmic Ointment
  • RxCUI: 308511 - bacitracin (as bacitracin zinc) 500 UNT / polymyxin B (as polymyxin B sulfate) 10,000 UNT per GM Ophthalmic Ointment

Clinical Specifications

Proprietary Name
Bacitracin Zinc And Polymyxin B Sulfate
Dosage Form
-
Usage Information
Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment 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
E. Fougera & Co., A Division Of Nycomed Us Inc.
FDA Application #
ANDA065022
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-28-2008
Listing Expiration
12-31-2018
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 0168-0273-38 identifies a specific commercial package of 3.5 g in 1 tube of Bacitracin Zinc And Polymyxin B Sulfate, labeled by E. Fougera & Co., A Division Of Nycomed Us 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 E. Fougera & Co., A Division Of Nycomed Us Inc. on August 28, 2008. The current certification is valid through December 31, 2018.

How is this E. Fougera & Co., A Division Of Nycomed Us Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00168027338. 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 (4-4-2)
0168-0273-38
11-Digit CMS (5-4-2)
00168-0273-38

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