Elidel
NDC Package 0187-5103-04

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.

Elidel 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). Marketed by Bausch Health Us, Llc, this product is identified by NDC 0187-5103 and is authorized under FDA application NDA021302.

Identification & Billing

NDC Package Code
0187-5103-04
Package Description
1 TUBE in 1 CARTON / 5 g in 1 TUBE
Product Code
0187-5103
11-Digit Billing Format
00187510304

Clinical Specifications

Proprietary Name
Elidel
Dosage Form
-
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
Bausch Health Us, Llc
FDA Application #
NDA021302
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-02-2001
End Marketing Date
05-31-2025
Listing Expiration
05-31-2025
Exclude Flag
D
Sample Package
Yes

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 0187-5103-04 identifies a specific commercial package of 1 tube in 1 carton / 5 g in 1 tube of Elidel, labeled by Bausch Health Us, Llc. 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 Bausch Health Us, Llc on December 02, 2001. The current certification is valid through May 31, 2025.

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 Bausch Health Us, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00187510304. 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 (4-4-2)
0187-5103-04
11-Digit CMS (5-4-2)
00187-5103-04

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