Zoledronic Acid
NDC Package 67457-920-05

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

Package Information

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

Zoledronic Acid is a medication used to treat high blood calcium levels (hypercalcemia) that may occur with cancer. Marketed by Mylan Institutional Llc, this product is identified by NDC 67457-920 and is authorized under FDA application ANDA202650.

Identification & Billing

NDC Package Code
67457-920-05
Package Description
1 VIAL in 1 CARTON / 5 mL in 1 VIAL
Product Code
67457-920
11-Digit Billing Format
67457092005

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
Mylan Institutional Llc
FDA Application #
ANDA202650
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-12-2020
End Marketing Date
05-31-2021
Listing Expiration
05-31-2021
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J3489
Source: PDAC
INJECTION, ZOLEDRONIC ACID, 1 MG
HCPCS Dosage 1 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 67457-920-05 identifies a specific commercial package of 1 vial in 1 carton / 5 ml in 1 vial of Zoledronic Acid, labeled by Mylan Institutional Llc. 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 Mylan Institutional Llc on October 12, 2020. The current certification is valid through May 31, 2021.

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 Mylan Institutional Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67457092005. 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)
67457-920-05
11-Digit CMS (5-4-2)
67457-0920-05

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