Calcipotriene And Betamethasone Dipropionate Suspension
NDC Package 51672-1402-4

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 Sun Pharmaceutical Industries, Inc., this product is identified by NDC 51672-1402 and is authorized under FDA application ANDA213269.

Identification & Billing

NDC Package Code
51672-1402-4
Package Description
1 BOTTLE in 1 CARTON / 60 g in 1 BOTTLE
Product Code
51672-1402
11-Digit Billing Format
51672140204

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
Sun Pharmaceutical Industries, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA213269
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-02-2020
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 (51672-1402). Click a package code to view its specific billing and regulatory data.

51672-1402-8
2 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 51672-1402-4 identifies a specific commercial package of 1 bottle in 1 carton / 60 g in 1 bottle of Calcipotriene And Betamethasone Dipropionate, a human prescription drug labeled by Sun Pharmaceutical Industries, 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 Sun Pharmaceutical Industries, Inc. on September 02, 2020. The current certification is valid through December 31, 2026.

How is this Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51672140204. 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 (5-4-1)
51672-1402-4
11-Digit CMS (5-4-2)
51672-1402-04

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