Dermotic
NDC Package 54868-6119-0

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.

Dermotic is a medication used to treat eczema of the outer ear (also known as chronic itchy ear). Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-6119 and is authorized under FDA application NDA019452.

Identification & Billing

NDC Package Code
54868-6119-0
Package Description
1 BOTTLE in 1 CARTON / 20 mL in 1 BOTTLE
Product Code
54868-6119
11-Digit Billing Format
54868611900

Clinical Specifications

Proprietary Name
Dermotic
Dosage Form
-
Usage Information
This medication is used to treat eczema of the outer ear (also known as chronic itchy ear). The main symptom is itchiness, but redness, flaking, or oozing may also occur. Fluocinolone reduces these symptoms. This medication is a low- to medium-strength corticosteroid.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA019452
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-16-2010
End Marketing Date
06-30-2013
Listing Expiration
06-30-2013
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 54868-6119-0 identifies a specific commercial package of 1 bottle in 1 carton / 20 ml in 1 bottle of Dermotic, labeled by Physicians Total Care, 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 Physicians Total Care, Inc. on July 16, 2010. The current certification is valid through June 30, 2013.

What are the primary indications for this medication?

This medication is used to treat eczema of the outer ear (also known as chronic itchy ear). The main symptom is itchiness, but redness, flaking, or oozing may also occur. Fluocinolone reduces these symptoms. This medication is a low- to medium-strength corticosteroid.

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: 54868611900. 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)
54868-6119-0
11-Digit CMS (5-4-2)
54868-6119-00

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