Antibiotic Application Ointment
NDC Package 49687-0013-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Antibiotic Application (bacitracin zinc, neomycin sulfate, polymyxin b sulfate) ointment is • Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle • Clean the affected area. This formulation utilizes a ointment delivery system. Marketed by Cmc Group, Inc., this product is identified by NDC 49687-0013 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
49687-0013-0
Package Description
10 PACKAGE in 1 KIT / .9 g in 1 PACKAGE
Product Code
49687-0013
11-Digit Billing Format
49687001300
RxNorm Crosswalk
  • RxCUI: 1012100 - benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical Cream
  • RxCUI: 1012100 - benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical Cream
  • RxCUI: 1012100 - benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical Cream
  • RxCUI: 1038558 - benzalkonium chloride 0.13 % Medicated Pad
  • RxCUI: 1038558 - benzalkonium chloride 1.3 MG/ML Medicated Pad

Clinical Specifications

Proprietary Name
Antibiotic Application
Non-Proprietary Name
Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate
Substance Name
Bacitracin Zinc; Neomycin Sulfate; Polymyxin B Sulfate
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
Pharmacologic Class
Usage Information
• Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle • Clean the affected area. • Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily. • May be covered with a sterile bandage. Clean the affected areaAdults and children 2 years of age and older: Apply a small amount of this product to affected area not more than 3 times dailyChildren under 2 years of age: consult a doctorMay be covered with a sterile bandage Wet hands thoroughly with product and allow to dry without wiping.

Regulatory & Marketing

Labeler Name
Cmc Group, Inc.
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-06-2016
Listing Expiration
12-31-2026
Exclude Flag
N
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 49687-0013-0 identifies a specific commercial package of 10 package in 1 kit / .9 g in 1 package of Antibiotic Application, a human over the counter drug labeled by Cmc Group, Inc.. This ointment is formulated for topical use and contains bacitracin zinc; neomycin sulfate; polymyxin b sulfate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Cmc Group, Inc. on August 06, 2016. The current certification is valid through December 31, 2026.

How is this Cmc Group, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49687001300. 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 (5-4-1)
49687-0013-0
11-Digit CMS (5-4-2)
49687-0013-00

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