Zoledronic Acid Injection
NDC Package 68001-611-33

11-digit billing NDC: 68001061133 · Billing unit: ML · 100 ML per package
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. 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 Bluepoint Laboratories, this product is identified by NDC 68001-611 and is authorized under FDA application ANDA209578.

Identification & Billing

NDC Package Code
68001-611-33
Package Description
1 BAG in 1 CARTON / 100 mL in 1 BAG
Product Code
68001-611
11-Digit Billing Format
68001061133
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
100 ML
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
Bluepoint Laboratories
Product Type
Human Prescription Drug
FDA Application #
ANDA209578
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-08-2024
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.

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: ASP
Zoledronic acid 1mg
HCPCS Dosage 1 MG
Units / Pkg 5

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 68001-611-33 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 Bluepoint Laboratories. This product is billed per "ML" milliliter and contains an estimated amount of 100 billable units per package. 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 Bluepoint Laboratories on March 08, 2024. The current certification is valid through December 31, 2027.

How is this Bluepoint Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68001061133. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 100 total billable units per package. 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)
68001-611-33
11-Digit CMS (5-4-2)
68001-0611-33

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