Calcipotriene And Betamethasone Dipropionate Suspension
NDC Package 0713-0848-92

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 suspension is calcipotriene and betamethasone dipropionate topical suspension is indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older.Additional pediatric use information is approved for LEO Pharma A/S’s Taclonex® (calcipotriene and betamethasone dipropionate) Topical Suspension. This formulation utilizes a suspension delivery system. Marketed by Cosette Pharmaceuticals, Inc., this product is identified by NDC 0713-0848 and is authorized under FDA application ANDA210765.

Identification & Billing

NDC Package Code
0713-0848-92
Package Description
2 BOTTLE in 1 CARTON / 60 g in 1 BOTTLE
Product Code
0713-0848
11-Digit Billing Format
00713084892
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: 833461 - calcipotriene 0.005 % / betamethasone dipropionate 0.064 % Topical Suspension
  • RxCUI: 833461 - betamethasone 0.5 MG/ML / calcipotriene 0.05 MG/ML Topical Lotion
  • RxCUI: 833461 - betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) / calcipotriene 0.005 % Topical Suspension

Clinical Specifications

Proprietary Name
Calcipotriene And Betamethasone Dipropionate
Non-Proprietary Name
Calcipotriene And Betamethasone Dipropionate
Substance Name
Betamethasone Dipropionate; Calcipotriene
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
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 topical suspension is indicated for the topical treatment of plaque psoriasis of the scalp in patients 12 years and older and plaque psoriasis of the scalp and body in patients 18 years and older.Additional pediatric use information is approved for LEO Pharma A/S’s Taclonex® (calcipotriene and betamethasone dipropionate) Topical Suspension. However, due to LEO Pharma A/S’s marketing exclusivity rights, this drug product is not labeled with that information.

Regulatory & Marketing

Labeler Name
Cosette Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA210765
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-02-2024
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 (0713-0848). Click a package code to view its specific billing and regulatory data.

0713-0848-60
1 BOTTLE in 1 CARTON / 60 g in 1 BOTTLE

* 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 0713-0848-92 identifies a specific commercial package of 2 bottle in 1 carton / 60 g in 1 bottle of Calcipotriene And Betamethasone Dipropionate, a human prescription drug labeled by Cosette Pharmaceuticals, Inc.. This suspension 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 Cosette Pharmaceuticals, Inc. on August 02, 2024. The current certification is valid through December 31, 2026.

How is this Cosette Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00713084892. 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 (4-4-2)
0713-0848-92
11-Digit CMS (5-4-2)
00713-0848-92

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