Zoledronic Acid
NDC Package 17478-327-45

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Zoledronic Acid is a medication used to treat high blood calcium levels (hypercalcemia) that may occur with cancer. Marketed by Akorn, this product is identified by NDC 17478-327 and is authorized under FDA application ANDA202548.

Identification & Billing

NDC Package Code
17478-327-45
Package Description
4 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE
Product Code
17478-327
11-Digit Billing Format
17478032745
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zoledronic Acid
Dosage Form
-
Usage Information
This medication is used to treat high blood calcium levels (hypercalcemia) that may occur with cancer. Zoledronic acid is also used with cancer chemotherapy to treat bone problems that may occur with multiple myeloma and other types of cancer (such as breast, lung) that have spread to the bones. Zoledronic acid belongs to a class of drugs known as bisphosphonates. It lowers high blood calcium levels by reducing the amount of calcium released from your bones into your blood. It also works by slowing the breakdown of your bones by cancer to prevent bone fractures.

Regulatory & Marketing

Labeler Name
Akorn
FDA Application #
ANDA202548
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-22-2014
Listing Expiration
12-31-2023
Exclude Flag
I
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 (17478-327). Click a package code to view its specific billing and regulatory data.

17478-327-05
1 VIAL, SINGLE-DOSE in 1 CARTON / 5 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 17478-327-45 identifies a specific commercial package of 4 vial, single-dose in 1 carton / 5 ml in 1 vial, single-dose of Zoledronic Acid, 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 May 22, 2014. The current certification is valid through December 31, 2023.

What are the primary indications for this medication?

This medication is used to treat high blood calcium levels (hypercalcemia) that may occur with cancer. Zoledronic acid is also used with cancer chemotherapy to treat bone problems that may occur with multiple myeloma and other types of cancer (such as breast, lung) that have spread to the bones. Zoledronic acid belongs to a class of drugs known as bisphosphonates. It lowers high blood calcium levels by reducing the amount of calcium released from your bones into your blood. It also works by slowing the breakdown of your bones by cancer to prevent bone fractures.

How is this Akorn product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17478032745. 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)
17478-327-45
11-Digit CMS (5-4-2)
17478-0327-45

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