Doxercalciferol Injection, Solution
NDC Package 68083-359-50

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

Package Information

Doxercalciferol injection is a medication used to treat people with serious kidney disease on dialysis who have high levels of a certain substance (parathyroid hormone-PTH), which your body normally makes. This formulation utilizes a injection, solution delivery system. Marketed by Gland Pharma Limited, this product is identified by NDC 68083-359 and is authorized under FDA application ANDA210452.

Identification & Billing

NDC Package Code
68083-359-50
Package Description
50 VIAL, MULTI-DOSE in 1 CARTON / 2 mL in 1 VIAL, MULTI-DOSE (68083-359-01)
Product Code
68083-359
11-Digit Billing Format
68083035950
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Doxercalciferol
Non-Proprietary Name
Doxercalciferol
Substance Name
Doxercalciferol
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)
DOXERCALCIFEROL 4 ug/2mL
Pharmacologic Class
Usage Information
This medication is used to treat people with serious kidney disease on dialysis who have high levels of a certain substance (parathyroid hormone-PTH), which your body normally makes. High PTH levels affect the balance of other minerals in your body (calcium and phosphorus) and may cause weak bones. Doxercalciferol is a form of vitamin D. It works by decreasing PTH levels and increasing calcium/phosphorus levels in the body.

Regulatory & Marketing

Labeler Name
Gland Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA210452
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-26-2019
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 68083-359-50 identifies a specific commercial package of 50 vial, multi-dose in 1 carton / 2 ml in 1 vial, multi-dose (68083-359-01) of Doxercalciferol, a human prescription drug labeled by Gland Pharma Limited. This injection, solution is formulated for intravenous use and contains doxercalciferol 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 Gland Pharma Limited on September 26, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat people with serious kidney disease on dialysis who have high levels of a certain substance (parathyroid hormone-PTH), which your body normally makes. High PTH levels affect the balance of other minerals in your body (calcium and phosphorus) and may cause weak bones. Doxercalciferol is a form of vitamin D. It works by decreasing PTH levels and increasing calcium/phosphorus levels in the body.

How is this Gland Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083035950. 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)
68083-359-50
11-Digit CMS (5-4-2)
68083-0359-50

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