Pamidronate Disodium Injection
NDC Package 67457-430-10

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

Package Information

Pamidronate Disodium injection is pamidronate is used to treat high blood calcium levels and certain bone problems (bone metastases/lesions) that may occur with some types of cancer. This formulation utilizes a injection delivery system. Marketed by Mylan Institutional Llc, this product is identified by NDC 67457-430 and is authorized under FDA application ANDA078520.

Identification & Billing

NDC Package Code
67457-430-10
Package Description
1 VIAL in 1 CARTON / 10 mL in 1 VIAL
Product Code
67457-430
11-Digit Billing Format
67457043010
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Pamidronate Disodium
Non-Proprietary Name
Pamidronate Disodium
Substance Name
Pamidronate Disodium
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)
PAMIDRONATE DISODIUM 3 mg/mL
Pharmacologic Class
Usage Information
Pamidronate is used to treat high blood calcium levels and certain bone problems (bone metastases/lesions) that may occur with some types of cancer. It is also used to treat a certain type of bone disease (Paget's disease) that causes abnormal and weak bones. Pamidronate belongs to a class of drugs known as bisphosphonates. It works by slowing the release of calcium from bones to lower blood calcium levels, reducing the risk of broken bones (fractures) and reducing bone pain.

Regulatory & Marketing

Labeler Name
Mylan Institutional Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA078520
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-10-2011
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 67457-430-10 identifies a specific commercial package of 1 vial in 1 carton / 10 ml in 1 vial of Pamidronate Disodium, a human prescription drug labeled by Mylan Institutional Llc. This injection is formulated for intravenous use and contains pamidronate disodium 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 Mylan Institutional Llc on May 10, 2011. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Pamidronate is used to treat high blood calcium levels and certain bone problems (bone metastases/lesions) that may occur with some types of cancer. It is also used to treat a certain type of bone disease (Paget's disease) that causes abnormal and weak bones. Pamidronate belongs to a class of drugs known as bisphosphonates. It works by slowing the release of calcium from bones to lower blood calcium levels, reducing the risk of broken bones (fractures) and reducing bone pain.

How is this Mylan Institutional Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67457043010. 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)
67457-430-10
11-Digit CMS (5-4-2)
67457-0430-10

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