Cortisporin-tc
NDC Package 54868-0564-0
Package Information
Cortisporin-tc 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 54868-0564 and is authorized under FDA application NDA050356.
Identification & Billing
- 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
Regulatory & Marketing
Hierarchy Structure
- 54868 - Physicians Total Care, Inc.
- 54868-0564 - Cortisporin-tc
- 54868-0564-0 - 10 mL in 1 BOTTLE, DROPPER
- 54868-0564 - Cortisporin-tc
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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 54868-0564-0 identifies a specific commercial package of 10 ml in 1 bottle, dropper of Cortisporin-tc, labeled by Physicians Total Care, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 10 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 May 07, 2007. The current certification is valid through December 31, 2017.
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: 54868056400. 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:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.
