Roosin Triple Antibiotic
NDC Package 81552-005-01

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.

Roosin Triple Antibiotic is clean affected areaApply small amount 1  to 3 times dailyMay be covered with a sterile bandage. Marketed by Roosin Medical Co., Ltd, this product is identified by NDC 81552-005 and is authorized under FDA application part333B.

Identification & Billing

NDC Package Code
81552-005-01
Package Description
.5 g in 1 TUBE
Product Code
81552-005
11-Digit Billing Format
81552000501
RxNorm Crosswalk
  • RxCUI: 2539801 - bacitracin zinc 0.048 % / neomycin sulfate 1 % / polymyxin B sulfate 0.6 % Topical Ointment
  • RxCUI: 2539801 - bacitracin zinc 0.00048 MG/MG / neomycin sulfate 0.01 MG/MG / polymyxin B sulfate 0.006 MG/MG Topical Ointment

Clinical Specifications

Proprietary Name
Roosin Triple Antibiotic
Dosage Form
-
Usage Information
Clean affected areaApply small amount 1  to 3 times dailyMay be covered with a sterile bandage

Regulatory & Marketing

Labeler Name
Roosin Medical Co., Ltd
FDA Application #
part333B
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
04-24-2021
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 81552-005-01 identifies a specific commercial package of .5 g in 1 tube of Roosin Triple Antibiotic, labeled by Roosin Medical Co., Ltd. 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 Roosin Medical Co., Ltd on April 24, 2021. The current certification is valid through December 31, 2022.

How is this Roosin Medical Co., Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81552000501. 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)
81552-005-01
11-Digit CMS (5-4-2)
81552-0005-01

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