Enstilar Aerosol, Foam
NDC Package 50222-302-91

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

Package Information

Enstilar (calcipotriene and betamethasone dipropionate) aerosols is a medication used to treat psoriasis. This formulation utilizes a aerosol, foam delivery system. Marketed by Leo Pharma Inc., this product is identified by NDC 50222-302 and is authorized under FDA application NDA207589.

Identification & Billing

NDC Package Code
50222-302-91
Package Description
1 CAN in 1 CARTON / 60 g in 1 CAN
Product Code
50222-302
11-Digit Billing Format
50222030291
RxNorm Crosswalk
  • RxCUI: 1716094 - calcipotriene 0.005 % / betamethasone propionate 0.064 % Topical Foam
  • RxCUI: 1716094 - betamethasone dipropionate 0.643 MG/ML / calcipotriene 0.05 MG/ML Topical Foam
  • RxCUI: 1716099 - Enstilar 0.005 % / 0.064 % Topical Foam
  • RxCUI: 1716099 - betamethasone dipropionate 0.643 MG/ML / calcipotriene 0.05 MG/ML Topical Foam [Enstilar]
  • RxCUI: 1716099 - Enstilar (calcipotriene 0.005 % / betamethasone dipropionate 0.064 % ) Topical Foam

Clinical Specifications

Proprietary Name
Enstilar
Non-Proprietary Name
Calcipotriene And Betamethasone Dipropionate
Substance Name
Betamethasone Dipropionate; Calcipotriene Monohydrate
Dosage Form
Aerosol, Foam - A dosage form containing one or more active ingredients, surfactants, aqueous or nonaqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged.
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)
Pharmacologic Class
Usage Information
This medication is used to treat psoriasis. It helps to reduce the redness, thickening, and scaling of the skin that occurs with this condition. Healthy skin lowers your risk for infection and protects you against the environment. This product contains 2 drugs. Betamethasone is a very strong corticosteroid drug that works by decreasing swelling, redness, and itching. Calcipotriene is a form of vitamin D. It is also known as calcipotriol in other countries. It works by slowing down the growth of skin cells so that they don't build up into thickened, scaly skin patches. This product should not be used if you have certain types of psoriasis (skin patches with pus-filled blisters, psoriasis over most of your body with intense redness/shedding/oozing). Consult your doctor for more information.

Regulatory & Marketing

Labeler Name
Leo Pharma Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA207589
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-16-2015
Listing Expiration
12-31-2026
Exclude Flag
N
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (50222-302). Click a package code to view its specific billing and regulatory data.

50222-302-60
1 CAN in 1 CARTON / 60 g in 1 CAN
50222-302-66
2 CAN in 1 CARTON / 60 g in 1 CAN

* 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 50222-302-91 identifies a specific commercial package of 1 can in 1 carton / 60 g in 1 can of Enstilar, a human prescription drug labeled by Leo Pharma Inc.. This aerosol, foam is formulated for topical use and contains betamethasone dipropionate; calcipotriene monohydrate 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 Leo Pharma Inc. on October 16, 2015. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat psoriasis. It helps to reduce the redness, thickening, and scaling of the skin that occurs with this condition. Healthy skin lowers your risk for infection and protects you against the environment. This product contains 2 drugs. Betamethasone is a very strong corticosteroid drug that works by decreasing swelling, redness, and itching. Calcipotriene is a form of vitamin D. It is also known as calcipotriol in other countries. It works by slowing down the growth of skin cells so that they don't build up into thickened, scaly skin patches. This product should not be used if you have certain types of psoriasis (skin patches with pus-filled blisters, psoriasis over most of your body with intense redness/shedding/oozing). Consult your doctor for more information.

How is this Leo Pharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50222030291. 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)
50222-302-91
11-Digit CMS (5-4-2)
50222-0302-91

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