Etidronate Disodium
NDC Package 55567-094-06

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Etidronate Disodium is etidronate is used to treat a certain type of bone disease called Paget's disease. Marketed by Genpharm Ulc, this product is identified by NDC 55567-094 and is authorized under FDA application ANDA075800.

Identification & Billing

NDC Package Code
55567-094-06
Package Description
100 TABLET in 1 BLISTER PACK
Product Code
55567-094
11-Digit Billing Format
55567009406

Clinical Specifications

Proprietary Name
Etidronate Disodium
Dosage Form
-
Usage Information
Etidronate is used to treat a certain type of bone disease called Paget's disease. This disease weakens and deforms bones. Etidronate works by slowing bone loss, helping to keep your bones strong and less likely to break. It also helps reduce bone pain from this disease. This medication belongs to a class of drugs called bisphosphonates. Etidronate is also used to prevent or treat bone problems that may occur after hip replacement surgery or spinal cord injury.

Regulatory & Marketing

Labeler Name
Genpharm Ulc
FDA Application #
ANDA075800
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-01-2015
End Marketing Date
11-24-2015
Listing Expiration
11-24-2015
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (55567-094). Click a package code to view its specific billing and regulatory data.

55567-094-16
60 TABLET in 1 BOTTLE, PLASTIC
55567-094-25
500 TABLET in 1 BOTTLE, PLASTIC

* 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 55567-094-06 identifies a specific commercial package of 100 tablet in 1 blister pack of Etidronate Disodium, labeled by Genpharm Ulc. 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 Genpharm Ulc on November 01, 2015. The current certification is valid through November 24, 2015.

What are the primary indications for this medication?

Etidronate is used to treat a certain type of bone disease called Paget's disease. This disease weakens and deforms bones. Etidronate works by slowing bone loss, helping to keep your bones strong and less likely to break. It also helps reduce bone pain from this disease. This medication belongs to a class of drugs called bisphosphonates. Etidronate is also used to prevent or treat bone problems that may occur after hip replacement surgery or spinal cord injury.

How is this Genpharm Ulc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55567009406. 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)
55567-094-06
11-Digit CMS (5-4-2)
55567-0094-06

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