Calcipotriene Solution
NDC Package 0713-0318-53

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

Package Information

Calcipotriene solution is a medication used to treat psoriasis. This formulation utilizes a solution delivery system. Marketed by Cosette Pharmaceuticals, Inc., this product is identified by NDC 0713-0318 and is authorized under FDA application ANDA078468.

Identification & Billing

NDC Package Code
0713-0318-53
Package Description
1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE
Product Code
0713-0318
11-Digit Billing Format
00713031853
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Calcipotriene
Non-Proprietary Name
Calcipotriene
Substance Name
Calcipotriene
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
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)
CALCIPOTRIENE .05 mg/mL
Pharmacologic Class
Usage Information
This medication is used to treat psoriasis. Calcipotriene is a form of vitamin D. It works by slowing down the growth of skin cells.

Regulatory & Marketing

Labeler Name
Cosette Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA078468
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-24-2011
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 0713-0318-53 identifies a specific commercial package of 1 bottle in 1 carton / 60 ml in 1 bottle of Calcipotriene, a human prescription drug labeled by Cosette Pharmaceuticals, Inc.. This solution is formulated for topical use and contains 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 March 24, 2011. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat psoriasis. Calcipotriene is a form of vitamin D. It works by slowing down the growth of skin cells.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00713031853. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
0713-0318-53
11-Digit CMS (5-4-2)
00713-0318-53

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