Coly-mycin S
NDC Package 63481-421-05

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 Endo Pharmaceuticals Inc., this product is identified by NDC 63481-421 and is authorized under FDA application NDA050356.

Identification & Billing

NDC Package Code
63481-421-05
Package Description
10 mL in 1 BOTTLE, DROPPER
Product Code
63481-421
11-Digit Billing Format
63481042105
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
10 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
Endo Pharmaceuticals Inc.
FDA Application #
NDA050356
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-18-2016
End Marketing Date
04-30-2020
Listing Expiration
04-30-2020
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 63481-421-05 identifies a specific commercial package of 10 ml in 1 bottle, dropper of Coly-mycin S, labeled by Endo Pharmaceuticals 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 Endo Pharmaceuticals Inc. on April 18, 2016. The current certification is valid through April 30, 2020.

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 Endo Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63481042105. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 10 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)
63481-421-05
11-Digit CMS (5-4-2)
63481-0421-05

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