Calcitriol Ointment
NDC Package 45802-608-01

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

Package Information

Calcitriol ointment is calcitriol is a man-made active form of vitamin D. This formulation utilizes a ointment delivery system. Marketed by Padagis Israel Pharmaceuticals Ltd, this product is identified by NDC 45802-608 and is authorized under FDA application NDA022087.

Identification & Billing

NDC Package Code
45802-608-01
Package Description
1 TUBE in 1 CARTON / 100 g in 1 TUBE
Product Code
45802-608
11-Digit Billing Format
45802060801
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
100 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Calcitriol
Non-Proprietary Name
Calcitriol
Substance Name
Calcitriol
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)
CALCITRIOL 3 ug/g
Pharmacologic Class
Usage Information
Calcitriol is a man-made active form of vitamin D. Most people get enough vitamin D from exposure to the sun and from fortified food products (e.g., dairy products, vitamins). Vitamin D helps control parathyroid hormone and the levels of certain minerals (e.g., calcium, phosphorus) that are needed for building and keeping strong bones. Before regular vitamin D can be used by the body, it needs to be changed to the active form by the liver and kidneys. Calcitriol is used in patients with kidney disease who can't make enough of the active form of Vitamin D. This medication is also used to prevent and treat certain types of calcium/phosphorus/parathyroid problems that can happen with long-term kidney dialysis or hypoparathyroidism. Calcitriol is usually used along with specific diet recommendations and sometimes other medications.

Regulatory & Marketing

Labeler Name
Padagis Israel Pharmaceuticals Ltd
Product Type
Human Prescription Drug
FDA Application #
NDA022087
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
03-08-2012
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 45802-608-01 identifies a specific commercial package of 1 tube in 1 carton / 100 g in 1 tube of Calcitriol, a human prescription drug labeled by Padagis Israel Pharmaceuticals Ltd. This ointment is formulated for topical use and contains calcitriol 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 March 08, 2012. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Calcitriol is a man-made active form of vitamin D. Most people get enough vitamin D from exposure to the sun and from fortified food products (e.g., dairy products, vitamins). Vitamin D helps control parathyroid hormone and the levels of certain minerals (e.g., calcium, phosphorus) that are needed for building and keeping strong bones. Before regular vitamin D can be used by the body, it needs to be changed to the active form by the liver and kidneys. Calcitriol is used in patients with kidney disease who can't make enough of the active form of Vitamin D. This medication is also used to prevent and treat certain types of calcium/phosphorus/parathyroid problems that can happen with long-term kidney dialysis or hypoparathyroidism. Calcitriol is usually used along with specific diet recommendations and sometimes other medications.

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: 45802060801. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 100 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)
45802-608-01
11-Digit CMS (5-4-2)
45802-0608-01

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