Coly-mycin S
NDC Package 54868-0399-0

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 discontinued by the firm.

Coly-mycin S is this ear drop is used to treat outer ear infections caused by bacteria (also known as swimmer's ear). Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-0399 and is authorized under FDA application NDA050356.

Identification & Billing

NDC Package Code
54868-0399-0
Package Description
5 mL in 1 BOTTLE, DROPPER
Product Code
54868-0399
11-Digit Billing Format
54868039900
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
5 ML

Clinical Specifications

Proprietary Name
Coly-mycin S
Dosage Form
-
Usage Information
This ear drop is used to treat outer ear infections caused by bacteria (also known as swimmer's ear). This product contains neomycin and colistin, which are antibiotics that work by stopping the growth of bacteria. It also contains hydrocortisone, which is an anti-inflammatory corticosteroid that works by reducing ear swelling and discomfort, and thonzonium, which helps this medication pass through dead cells and pus inside the ear. This medication treats only bacterial ear infections. It will not work for other types of ear infections. Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA050356
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-01-2007
End Marketing Date
06-30-2012
Listing Expiration
06-30-2012
Exclude Flag
D
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 54868-0399-0 identifies a specific commercial package of 5 ml in 1 bottle, dropper of Coly-mycin S, labeled by Physicians Total Care, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 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 Physicians Total Care, Inc. on November 01, 2007. The current certification is valid through June 30, 2012.

What are the primary indications for this medication?

This ear drop is used to treat outer ear infections caused by bacteria (also known as swimmer's ear). This product contains neomycin and colistin, which are antibiotics that work by stopping the growth of bacteria. It also contains hydrocortisone, which is an anti-inflammatory corticosteroid that works by reducing ear swelling and discomfort, and thonzonium, which helps this medication pass through dead cells and pus inside the ear. This medication treats only bacterial ear infections. It will not work for other types of ear infections. Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868039900. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 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 (5-4-1)
54868-0399-0
11-Digit CMS (5-4-2)
54868-0399-00

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