Etidronate Disodium
NDC Package 0378-3286-91

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.

Etidronate Disodium is etidronate is used to treat a certain type of bone disease called Paget's disease. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-3286 and is authorized under FDA application ANDA075800.

Identification & Billing

NDC Package Code
0378-3286-91
Package Description
60 TABLET in 1 BOTTLE, PLASTIC
Product Code
0378-3286
11-Digit Billing Format
00378328691
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA

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
Mylan Pharmaceuticals Inc.
FDA Application #
ANDA075800
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-02-2008
End Marketing Date
11-30-2019
Listing Expiration
11-30-2019
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 0378-3286-91 identifies a specific commercial package of 60 tablet in 1 bottle, plastic of Etidronate Disodium, labeled by Mylan Pharmaceuticals Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 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 Mylan Pharmaceuticals Inc. on January 02, 2008. The current certification is valid through November 30, 2019.

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 Mylan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378328691. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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 (4-4-2)
0378-3286-91
11-Digit CMS (5-4-2)
00378-3286-91

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