Paricalcitol Injection, Solution
NDC Package 16729-310-63

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

Paricalcitol injection is paricalcitol is a man-made active form of vitamin D, which is needed for building and keeping strong bones. This formulation utilizes a injection, solution delivery system. Marketed by Accord Healthcare, Inc., this product is identified by NDC 16729-310 and is authorized under FDA application NDA207174.

Identification & Billing

NDC Package Code
16729-310-63
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE
Product Code
16729-310
11-Digit Billing Format
16729031063
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Paricalcitol
Non-Proprietary Name
Paricalcitol
Substance Name
Paricalcitol
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
PARICALCITOL 2 ug/mL
Pharmacologic Class
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
Accord Healthcare, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA207174
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-24-2016
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 (16729-310). Click a package code to view its specific billing and regulatory data.

16729-310-08
25 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE

* 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 16729-310-63 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 1 ml in 1 vial, single-dose of Paricalcitol, a human prescription drug labeled by Accord Healthcare, Inc.. This injection, solution is formulated for intravenous use and contains paricalcitol 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 Accord Healthcare, Inc. on March 24, 2016. The current certification is valid through December 31, 2026.

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 Accord Healthcare, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16729031063. 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 (5-3-2)
16729-310-63
11-Digit CMS (5-4-2)
16729-0310-63

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