Pimecrolimus Cream
NDC Package 68682-110-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Pimecrolimus cream 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 cream delivery system. Marketed by Oceanside Pharmaceuticals, this product is identified by NDC 68682-110 and is authorized under FDA application NDA021302.

Identification & Billing

NDC Package Code
68682-110-01
Package Description
1 TUBE in 1 CARTON / 30 g in 1 TUBE
Product Code
68682-110
11-Digit Billing Format
68682011001
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
30 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Pimecrolimus
Non-Proprietary Name
Pimecrolimus
Substance Name
Pimecrolimus
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
PIMECROLIMUS 10 mg/g
Pharmacologic Class
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
Oceanside Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
NDA021302
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
11-26-2018
Listing Expiration
12-31-2027
Exclude Flag
N
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 68682-110-01 identifies a specific commercial package of 1 tube in 1 carton / 30 g in 1 tube of Pimecrolimus, a human prescription drug labeled by Oceanside Pharmaceuticals. This cream is formulated for topical 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 Oceanside Pharmaceuticals on November 26, 2018. The current certification is valid through December 31, 2027.

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 Oceanside Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68682011001. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 30 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)
68682-110-01
11-Digit CMS (5-4-2)
68682-0110-01

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