Cortisporin Tc Suspension
NDC Package 63481-529-10

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

Package Information

Cortisporin Tc (colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate) suspension is cortisporin®TC Otic is indicated for the treatment of superficial bacterial infections of the external auditory canal, caused by organisms susceptible to the action of the antibiotics; and for the treatment of infections of mastoidectomy and fenestration cavities, caused by organisms susceptible to the antibiotics. This formulation utilizes a suspension delivery system. Marketed by Endo Usa, Inc., this product is identified by NDC 63481-529 and is authorized under FDA application NDA050356.

Identification & Billing

NDC Package Code
63481-529-10
Package Description
10 mL in 1 BOTTLE, DROPPER
Product Code
63481-529
11-Digit Billing Format
63481052910
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
10 ML
RxNorm Crosswalk
  • RxCUI: 854992 - colistin sulfate 3 MG / neomycin sulfate 3.3 MG / thonzonium bromide 0.5 MG / hydrocortisone acetate 10 MG in 1 ML Otic Suspension
  • RxCUI: 854992 - colistin 3 MG/ML / hydrocortisone 10 MG/ML / neomycin 3.3 MG/ML / thonzonium bromide 0.5 MG/ML Otic Suspension
  • RxCUI: 854992 - colistin 0.3 % / hydrocortisone 1 % / neomycin 0.33 % / thonzonium bromide 0.05 % Otic Suspension
  • RxCUI: 854997 - Cortisporin-TC 3 MG / 3.3 MG / 0.5 MG / 10 MG in 1 ML Otic Suspension
  • RxCUI: 854997 - colistin 3 MG/ML / hydrocortisone 10 MG/ML / neomycin 3.3 MG/ML / thonzonium bromide 0.5 MG/ML Otic Suspension [Cortisporin-TC]

Clinical Specifications

Proprietary Name
Cortisporin Tc
Non-Proprietary Name
Colistin Sulfate, Neomycin Sulfate, Thonzonium Bromide And Hydrocortisone Acetate
Substance Name
Colistin Sulfate; Hydrocortisone Acetate; Neomycin Sulfate; Thonzonium Bromide
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Auricular (otic) - Administration to or by way of the ear.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Cortisporin®TC Otic is indicated for the treatment of superficial bacterial infections of the external auditory canal, caused by organisms susceptible to the action of the antibiotics; and for the treatment of infections of mastoidectomy and fenestration cavities, caused by organisms susceptible to the antibiotics.

Regulatory & Marketing

Labeler Name
Endo Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA050356
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-03-2019
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 63481-529-10 identifies a specific commercial package of 10 ml in 1 bottle, dropper of Cortisporin Tc, a human prescription drug labeled by Endo Usa, Inc.. This suspension is formulated for auricular (otic) use and contains colistin sulfate; hydrocortisone acetate; neomycin sulfate; thonzonium bromide 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 Endo Usa, Inc. on June 03, 2019. The current certification is valid through December 31, 2026.

How is this Endo Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63481052910. 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)
63481-529-10
11-Digit CMS (5-4-2)
63481-0529-10

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