Alendronate Sodium
NDC Package 55695-012-00

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 inactivated by the FDA.

Alendronate Sodium is alendronate is used to prevent and treat certain types of bone loss (osteoporosis) in adults. Marketed by Department Of State Health Services, Pharmacy Branch, this product is identified by NDC 55695-012 and is authorized under FDA application ANDA076984.

Identification & Billing

NDC Package Code
55695-012-00
Package Description
1 BLISTER PACK in 1 BOX, UNIT-DOSE / 4 TABLET in 1 BLISTER PACK
Product Code
55695-012
11-Digit Billing Format
55695001200
RxNorm Crosswalk

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
Department Of State Health Services, Pharmacy Branch
FDA Application #
ANDA076984
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-04-2008
Listing Expiration
12-31-2019
Exclude Flag
I
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 55695-012-00 identifies a specific commercial package of 1 blister pack in 1 box, unit-dose / 4 tablet in 1 blister pack of Alendronate Sodium, labeled by Department Of State Health Services, Pharmacy Branch. 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 Department Of State Health Services, Pharmacy Branch on August 04, 2008. The current certification is valid through December 31, 2019.

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 Department Of State Health Services, Pharmacy Branch product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55695001200. 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)
55695-012-00
11-Digit CMS (5-4-2)
55695-0012-00

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