Pimecrolimus Powder
NDC Package 62227-024-01

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Pimecrolimus powders is pimecrolimus is used to treat certain skin conditions such as eczema (atopic dermatitis) in people who should not use or have not responded to other eczema medications (e.g., topical steroids). This formulation utilizes a powder delivery system. Marketed by Brightgene Bio-medical Technology Co., Ltd., this product is identified by NDC 62227-024.

Identification & Billing

NDC Package Code
62227-024-01
Package Description
3.4 kg in 1 BAG
Product Code
62227-024
11-Digit Billing Format
62227002401

Clinical Specifications

Proprietary Name
Pimecrolimus
Non-Proprietary Name
Pimecrolimus
Substance Name
Pimecrolimus
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
PIMECROLIMUS 1 kg/kg
Usage Information
Pimecrolimus is used to treat certain skin conditions such as eczema (atopic dermatitis) in people who should not use or have not responded to other eczema medications (e.g., topical steroids). Eczema is an allergic-type condition that causes red, irritated, and itchy skin. This drug works by changing the skin's defense (immune) system, thereby decreasing the allergic reaction that causes eczema. Pimecrolimus 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 (e.g., following an organ transplant).

Regulatory & Marketing

Labeler Name
Brightgene Bio-medical Technology Co., Ltd.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
08-18-2022
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 62227-024-01 identifies a specific commercial package of 3.4 kg in 1 bag of Pimecrolimus (UNFINISHED drug), a bulk ingredient labeled by Brightgene Bio-medical Technology Co., Ltd.. This powder is formulated for use and contains pimecrolimus 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 Brightgene Bio-medical Technology Co., Ltd. on August 18, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Pimecrolimus is used to treat certain skin conditions such as eczema (atopic dermatitis) in people who should not use or have not responded to other eczema medications (e.g., topical steroids). Eczema is an allergic-type condition that causes red, irritated, and itchy skin. This drug works by changing the skin's defense (immune) system, thereby decreasing the allergic reaction that causes eczema. Pimecrolimus 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 (e.g., following an organ transplant).

How is this Brightgene Bio-medical Technology Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62227002401. 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)
62227-024-01
11-Digit CMS (5-4-2)
62227-0024-01

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