Calcipotriene And Betamethasone Dipropionate Ointment
NDC Package 45802-816-96

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

Calcipotriene And Betamethasone Dipropionate (calcipotriene, betamethasone dipropionate) ointment is calcipotriene and Betamethasone Dipropionate Ointment is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. This formulation utilizes a ointment delivery system. Marketed by Padagis Israel Pharmaceuticals Ltd, this product is identified by NDC 45802-816 and is authorized under FDA application ANDA200174.

Identification & Billing

NDC Package Code
45802-816-96
Package Description
1 TUBE in 1 CARTON / 60 g in 1 TUBE
Product Code
45802-816
11-Digit Billing Format
45802081696
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
60 GM
RxNorm Crosswalk
  • RxCUI: 388525 - calcipotriene 0.005 % / betamethasone dipropionate 0.064 % Topical Ointment
  • RxCUI: 388525 - betamethasone 0.0005 MG/MG / calcipotriene 0.00005 MG/MG Topical Ointment
  • RxCUI: 388525 - betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) / calcipotriene 0.005 % Topical Ointment
  • RxCUI: 388525 - betamethasone 0.05 % / calcipotriene 0.005 % Topical Ointment
  • RxCUI: 388525 - betamethasone 0.5 MG (betamethasone dipropionate 0.64 MG) / calcipotriene 0.05 MG per GM Topical Ointment

Clinical Specifications

Proprietary Name
Calcipotriene And Betamethasone Dipropionate
Non-Proprietary Name
Calcipotriene, Betamethasone Dipropionate
Substance Name
Betamethasone Dipropionate; Calcipotriene
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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)
Pharmacologic Class
Usage Information
Calcipotriene and Betamethasone Dipropionate Ointment is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.

Regulatory & Marketing

Labeler Name
Padagis Israel Pharmaceuticals Ltd
Product Type
Human Prescription Drug
FDA Application #
ANDA200174
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-30-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (45802-816). Click a package code to view its specific billing and regulatory data.

45802-816-01
1 TUBE in 1 CARTON / 100 g in 1 TUBE

* 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 45802-816-96 identifies a specific commercial package of 1 tube in 1 carton / 60 g in 1 tube of Calcipotriene And Betamethasone Dipropionate, a human prescription drug labeled by Padagis Israel Pharmaceuticals Ltd. This ointment is formulated for topical use and contains betamethasone dipropionate; calcipotriene 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 January 30, 2020. The current certification is valid through December 31, 2026.

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: 45802081696. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 60 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)
45802-816-96
11-Digit CMS (5-4-2)
45802-0816-96

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