Paricalcitol
NDC Package 17478-033-02

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Paricalcitol is a man-made active form of vitamin D, which is needed for building and keeping strong bones. Marketed by Akorn, this product is identified by NDC 17478-033 and is authorized under FDA application ANDA207692.

Identification & Billing

NDC Package Code
17478-033-02
Package Description
25 VIAL, MULTI-DOSE in 1 CARTON / 2 mL in 1 VIAL, MULTI-DOSE
Product Code
17478-033
11-Digit Billing Format
17478003302

Clinical Specifications

Proprietary Name
Paricalcitol
Dosage Form
-
Usage Information
Paricalcitol is a man-made active form of vitamin D, which is needed for building and keeping strong bones. Paricalcitol is used in patients with long-term kidney disease to treat or prevent high levels of a certain natural substance made by the body (parathyroid hormone). Too much parathyroid hormone can cause serious problems such as bone disorders. Most people get enough vitamin D from exposure to the sun and from fortified food products (e.g., dairy products, vitamins). Before regular vitamin D can be used by the body, it needs to be changed to the active form by the liver and kidneys. People with kidney disease cannot make enough of the active form of vitamin D. 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.

Regulatory & Marketing

Labeler Name
Akorn
FDA Application #
ANDA207692
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-17-2017
End Marketing Date
05-18-2022
Listing Expiration
05-18-2022
Exclude Flag
D
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 17478-033-02 identifies a specific commercial package of 25 vial, multi-dose in 1 carton / 2 ml in 1 vial, multi-dose of Paricalcitol, labeled by Akorn. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Akorn on October 17, 2017. The current certification is valid through May 18, 2022.

What are the primary indications for this medication?

Paricalcitol is a man-made active form of vitamin D, which is needed for building and keeping strong bones. Paricalcitol is used in patients with long-term kidney disease to treat or prevent high levels of a certain natural substance made by the body (parathyroid hormone). Too much parathyroid hormone can cause serious problems such as bone disorders. Most people get enough vitamin D from exposure to the sun and from fortified food products (e.g., dairy products, vitamins). Before regular vitamin D can be used by the body, it needs to be changed to the active form by the liver and kidneys. People with kidney disease cannot make enough of the active form of vitamin D. 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.

How is this Akorn product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17478003302. 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)
17478-033-02
11-Digit CMS (5-4-2)
17478-0033-02

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