Pamidronate Disodium
NDC Package 55390-159-01

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.

Pamidronate Disodium 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. Marketed by Bedford Laboratories, this product is identified by NDC 55390-159 and is authorized under FDA application ANDA075290.

Identification & Billing

NDC Package Code
55390-159-01
Package Description
1 VIAL in 1 BOX, UNIT-DOSE / 10 mL in 1 VIAL
Product Code
55390-159
11-Digit Billing Format
55390015901
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Pamidronate Disodium
Dosage Form
-
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
Bedford Laboratories
FDA Application #
ANDA075290
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-12-2002
End Marketing Date
08-31-2012
Listing Expiration
08-31-2012
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 55390-159-01 identifies a specific commercial package of 1 vial in 1 box, unit-dose / 10 ml in 1 vial of Pamidronate Disodium, labeled by Bedford Laboratories. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. 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 Bedford Laboratories on June 12, 2002. The current certification is valid through August 31, 2012.

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 Bedford Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55390015901. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
55390-159-01
11-Digit CMS (5-4-2)
55390-0159-01

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