Protopic
NDC Package 50222-211-60

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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 Leo Pharma Inc, this product is identified by NDC 50222-211 and is authorized under FDA application NDA050777.

Identification & Billing

NDC Package Code
50222-211-60
Package Description
1 TUBE in 1 CARTON / 60 g in 1 TUBE
Product Code
11-Digit Billing Format
50222021160
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
60 GM

Clinical Specifications

Proprietary Name
Protopic
Dosage Form
-
Usage Information
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).

Regulatory & Marketing

Labeler Name
Leo Pharma Inc
FDA Application #
NDA050777
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-08-2000
End Marketing Date
12-31-2024
Listing Expiration
12-31-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (50222-211). Click a package code to view its specific billing and regulatory data.

1 TUBE in 1 CARTON / 100 g in 1 TUBE
1 TUBE in 1 CARTON / 30 g in 1 TUBE

* 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 50222-211-60 identifies a specific commercial package of 1 tube in 1 carton / 60 g in 1 tube of Protopic, labeled by Leo Pharma 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 Leo Pharma Inc on December 08, 2000. The current certification is valid through December 31, 2024.

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 Leo Pharma Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50222021160. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 60 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)
50222-211-60
11-Digit CMS (5-4-2)
50222-0211-60

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