Zoledronic Acid Injection
NDC Package 69367-190-50

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

Zoledronic Acid injection is a medication used to treat high blood calcium levels (hypercalcemia) that may occur with cancer. This formulation utilizes a injection delivery system. Marketed by Westminster Pharmaceuticals, Llc, this product is identified by NDC 69367-190 and is authorized under FDA application ANDA202923.

Identification & Billing

NDC Package Code
69367-190-50
Package Description
1 VIAL in 1 CARTON / 5 mL in 1 VIAL
Product Code
69367-190
11-Digit Billing Format
69367019050
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
Non-Proprietary Name
Zoledronic Acid
Substance Name
Zoledronic Acid
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
ZOLEDRONIC ACID 4 mg/5mL
Pharmacologic Class
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
Westminster Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA202923
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-02-2023
End Marketing Date
12-01-2026
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.

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 69367-190-50 identifies a specific commercial package of 1 vial in 1 carton / 5 ml in 1 vial of Zoledronic Acid, a human prescription drug labeled by Westminster Pharmaceuticals, Llc. This injection is formulated for intravenous use and contains zoledronic acid 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 Westminster Pharmaceuticals, Llc on February 02, 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 Westminster Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69367019050. 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)
69367-190-50
11-Digit CMS (5-4-2)
69367-0190-50

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