Zoledronic Acid Injection
NDC Package 68083-256-01

11-digit billing NDC: 68083025601
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Zoledronic Acid injection is contraindicated in patients with the following conditions: • Hypocalcemia [see Warnings and Precautions (5.2)] • Creatinine clearance less than 35 mL/min and in those with evidence of acute renal impairment due to an increased risk of renal failure [see Warnings and Precautions (5.3)]. This formulation utilizes a injection delivery system. Marketed by Gland Pharma Limited, this product is identified by NDC 68083-256 and is authorized under FDA application ANDA209578.

Identification & Billing

NDC Package Code
68083-256-01
Package Description
1 BAG in 1 CARTON / 100 mL in 1 BAG
Product Code
68083-256
11-Digit Billing Format
68083025601
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 5 mg/100mL
Pharmacologic Class
Usage Information
Zoledronic acid injection is contraindicated in patients with the following conditions: • Hypocalcemia [see Warnings and Precautions (5.2)] • Creatinine clearance less than 35 mL/min and in those with evidence of acute renal impairment due to an increased risk of renal failure [see Warnings and Precautions (5.3)]. • Known hypersensitivity to zoledronic acid or any components of zoledronic acid injection. Hypersensitivity reactions, including urticaria, angioedema, and anaphylactic reaction/shock have been reported [see Adverse Reactions (6.2)].

Regulatory & Marketing

Labeler Name
Gland Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA209578
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-13-2017
Listing Expiration
12-31-2027
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 68083-256-01 identifies a specific commercial package of 1 bag in 1 carton / 100 ml in 1 bag of Zoledronic Acid, a human prescription drug labeled by Gland Pharma Limited. 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 Gland Pharma Limited on March 13, 2017. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083025601. 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)
68083-256-01
11-Digit CMS (5-4-2)
68083-0256-01

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