Zoledronic Acid
NDC Package 47335-962-41

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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 Sun Pharma Global Fze, this product is identified by NDC 47335-962 and is authorized under FDA application ANDA090018.

Identification & Billing

NDC Package Code
47335-962-41
Package Description
1 KIT in 1 CARTON * 5 mL in 1 VIAL, SINGLE-DOSE * 5 mL in 1 AMPULE (47335-247-40)
Product Code
47335-962
11-Digit Billing Format
47335096241
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.

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
Sun Pharma Global Fze
FDA Application #
ANDA090018
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-04-2013
End Marketing Date
12-31-2014
Listing Expiration
12-31-2014
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 47335-962-41 identifies a specific commercial package of 1 kit in 1 carton * 5 ml in 1 vial, single-dose * 5 ml in 1 ampule (47335-247-40) of Zoledronic Acid, labeled by Sun Pharma Global Fze. 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 Sun Pharma Global Fze on March 04, 2013. The current certification is valid through December 31, 2014.

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 Sun Pharma Global Fze product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 47335096241. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
47335-962-41
11-Digit CMS (5-4-2)
47335-0962-41

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