Adapalene Cream
NDC Package 45802-453-84

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

Package Information

Adapalene cream is a medication used to treat acne. This formulation utilizes a cream delivery system. Marketed by Padagis Israel Pharmaceuticals Ltd, this product is identified by NDC 45802-453 and is authorized under FDA application NDA020748.

Identification & Billing

NDC Package Code
45802-453-84
Package Description
1 TUBE in 1 CARTON / 45 g in 1 TUBE
Product Code
45802-453
11-Digit Billing Format
45802045384
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
45 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Adapalene
Non-Proprietary Name
Adapalene
Substance Name
Adapalene
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)
ADAPALENE .1 g/100g
Pharmacologic Class
Usage Information
This medication is used to treat acne. It may decrease the number and severity of acne pimples and promote quick healing of pimples that do develop. Adapalene belongs to a class of medications called retinoids. It works by affecting the growth of cells and decreasing swelling and inflammation.

Regulatory & Marketing

Labeler Name
Padagis Israel Pharmaceuticals Ltd
Product Type
Human Prescription Drug
FDA Application #
NDA020748
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
10-26-2010
Listing Expiration
12-31-2026
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 45802-453-84 identifies a specific commercial package of 1 tube in 1 carton / 45 g in 1 tube of Adapalene, a human prescription drug labeled by Padagis Israel Pharmaceuticals Ltd. This cream is formulated for topical use and contains adapalene 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 Padagis Israel Pharmaceuticals Ltd on October 26, 2010. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat acne. It may decrease the number and severity of acne pimples and promote quick healing of pimples that do develop. Adapalene belongs to a class of medications called retinoids. It works by affecting the growth of cells and decreasing swelling and inflammation.

How is this Padagis Israel Pharmaceuticals Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45802045384. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 45 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)
45802-453-84
11-Digit CMS (5-4-2)
45802-0453-84

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