Calcipotriene Ointment
NDC Package 68462-310-65

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 ointment is a medication used to treat psoriasis. This formulation utilizes a ointment delivery system. Marketed by Glenmark Pharmaceuticals Inc., Usa, this product is identified by NDC 68462-310 and is authorized under FDA application ANDA090633.

Identification & Billing

NDC Package Code
68462-310-65
Package Description
60 g in 1 TUBE
Product Code
68462-310
11-Digit Billing Format
68462031065
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
60 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Calcipotriene
Non-Proprietary Name
Calcipotriene
Substance Name
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)
CALCIPOTRIENE 50 ug/g
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
Glenmark Pharmaceuticals Inc., Usa
Product Type
Human Prescription Drug
FDA Application #
ANDA090633
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-24-2010
Listing Expiration
12-31-2027
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 (68462-310). Click a package code to view its specific billing and regulatory data.

68462-310-66
1 TUBE in 1 CARTON / 120 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 68462-310-65 identifies a specific commercial package of 60 g in 1 tube of Calcipotriene, a human prescription drug labeled by Glenmark Pharmaceuticals Inc., Usa. This ointment 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 Glenmark Pharmaceuticals Inc., Usa on March 24, 2010. The current certification is valid through December 31, 2027.

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 Glenmark Pharmaceuticals Inc., Usa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68462031065. 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)
68462-310-65
11-Digit CMS (5-4-2)
68462-0310-65

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