Alendronate Sodium
NDC Package 0378-3569-99

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.

Alendronate Sodium is alendronate is used to prevent and treat certain types of bone loss (osteoporosis) in adults. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-3569 and is authorized under FDA application ANDA076584.

Identification & Billing

NDC Package Code
0378-3569-99
Package Description
4 TABLET in 1 BOTTLE, PLASTIC
Product Code
0378-3569
11-Digit Billing Format
00378356999
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
4 EA

Clinical Specifications

Proprietary Name
Alendronate Sodium
Dosage Form
-
Usage Information
Alendronate is used to prevent and treat certain types of bone loss (osteoporosis) in adults. Osteoporosis causes bones to become thinner and break more easily. Your chance of developing osteoporosis increases as you age, after menopause, or if you are taking corticosteroid medications (such as prednisone) for a long time. This medication works by slowing bone loss. This effect helps maintain strong bones and reduce the risk of broken bones (fractures). Alendronate belongs to a class of drugs called bisphosphonates.

Regulatory & Marketing

Labeler Name
Mylan Pharmaceuticals Inc.
FDA Application #
ANDA076584
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-25-2011
End Marketing Date
05-09-2018
Listing Expiration
05-09-2018
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 0378-3569-99 identifies a specific commercial package of 4 tablet in 1 bottle, plastic of Alendronate Sodium, labeled by Mylan Pharmaceuticals Inc.. 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 March 25, 2011. The current certification is valid through May 09, 2018.

What are the primary indications for this medication?

Alendronate is used to prevent and treat certain types of bone loss (osteoporosis) in adults. Osteoporosis causes bones to become thinner and break more easily. Your chance of developing osteoporosis increases as you age, after menopause, or if you are taking corticosteroid medications (such as prednisone) for a long time. This medication works by slowing bone loss. This effect helps maintain strong bones and reduce the risk of broken bones (fractures). Alendronate belongs to a class of drugs called bisphosphonates.

How is this Mylan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378356999. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 4 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)
0378-3569-99
11-Digit CMS (5-4-2)
00378-3569-99

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