Bacitracin Zinc And Polymyxin B Sulfate
NDC Package 72189-017-35

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 for the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to bacitracin zinc and polymyxin B sulfate. Marketed by Direct_rx, this product is identified by NDC 72189-017 and is authorized under FDA application ANDA064046.

Identification & Billing

NDC Package Code
72189-017-35
Package Description
3.5 g in 1 BOTTLE
Product Code
72189-017
11-Digit Billing Format
72189001735
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
3.5 GM
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
For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to bacitracin zinc and polymyxin B sulfate.

Regulatory & Marketing

Labeler Name
Direct_rx
FDA Application #
ANDA064046
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-24-2019
Listing Expiration
12-31-2022
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 72189-017-35 identifies a specific commercial package of 3.5 g in 1 bottle of Bacitracin Zinc And Polymyxin B Sulfate, labeled by Direct_rx. This product is billed per "GM" gram and contains an estimated amount of 3.5 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 Direct_rx on July 24, 2019. The current certification is valid through December 31, 2022.

How is this Direct_rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72189001735. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 3.5 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)
72189-017-35
11-Digit CMS (5-4-2)
72189-0017-35

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