Pamidronate Disodium Pentahydrate Powder
NDC Package 62675-0718-1

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Pamidronate Disodium Pentahydrate powders 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 powder delivery system. Marketed by Laboratorium Ofichem Bv, this product is identified by NDC 62675-0718.

Identification & Billing

NDC Package Code
62675-0718-1
Package Description
5 kg in 1 CONTAINER
Product Code
62675-0718
11-Digit Billing Format
62675071801

Clinical Specifications

Proprietary Name
Pamidronate Disodium Pentahydrate
Non-Proprietary Name
Pamidronate Disodium Pentahydrate
Substance Name
Pamidronate Disodium
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
PAMIDRONATE DISODIUM 1 kg/kg
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
Laboratorium Ofichem Bv
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
07-02-2018
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 62675-0718-1 identifies a specific commercial package of 5 kg in 1 container of Pamidronate Disodium Pentahydrate (UNFINISHED drug), a bulk ingredient labeled by Laboratorium Ofichem Bv. This powder is formulated for 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 Laboratorium Ofichem Bv on July 02, 2018. The current certification is valid through December 31, 2026.

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 Laboratorium Ofichem Bv product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62675071801. 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 (5-4-1)
62675-0718-1
11-Digit CMS (5-4-2)
62675-0718-01

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