Protopic
NDC Package 54868-5233-0
Package Information
Protopic is this form of tacrolimus is used on the skin to treat a skin condition called eczema (atopic dermatitis) in patients who have not responded well to (or should not use) other eczema medications. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5233 and is authorized under FDA application NDA050777.
Identification & Billing
- RxCUI: 284520 - Protopic 0.1 % Topical Ointment
- RxCUI: 284520 - tacrolimus 0.001 MG/MG Topical Ointment [Protopic]
- RxCUI: 284520 - Protopic 0.001 MG/MG Topical Ointment
- RxCUI: 314266 - tacrolimus 0.1 % Topical Ointment
- RxCUI: 314266 - tacrolimus 0.001 MG/MG Topical Ointment
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 54868 - Physicians Total Care, Inc.
- 54868-5233 - Protopic
- 54868-5233-0 - 100 g in 1 TUBE
- 54868-5233 - Protopic
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.
Other Available Packages
The following commercial packages are registered under the same Product NDC (54868-5233). Click a package code to view its specific billing and regulatory data.
* 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 54868-5233-0 identifies a specific commercial package of 100 g in 1 tube of Protopic, labeled by Physicians Total Care, Inc.. This product is billed per "GM" gram and contains an estimated amount of 100 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 08, 2008. The current certification is valid through December 31, 2017.
What are the primary indications for this medication?
This form of tacrolimus is used on the skin to treat a skin condition called eczema (atopic dermatitis) in patients who have not responded well to (or should not use) other eczema medications. Eczema is an allergic-type condition that causes red, irritated, and itchy skin. This drug works by weakening the skin's defense (immune) system, thereby decreasing the allergic reaction and relieving the eczema. Tacrolimus belongs to a class of drugs known as topical calcineurin inhibitors (TCIs). This medication is not recommended if you have a history of a certain rare genetic disorder (Netherton's syndrome). Also, this medication should not be used by anyone who has a weakened immune system (for example, following an organ transplant).
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: 54868523300. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 100 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.
