Alendronate Sodium
NDC Package 54868-5860-1

11-digit billing NDC: 54868586001
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 inactivated by the FDA.

Alendronate Sodium is tablets are indicated for:Treatment and prevention of osteoporosis in postmenopausal womenFor the treatment of osteoporosis, alendronate sodium tablets increase bone mass and reduce the incidence of fractures, including those of the hip and spine (vertebral compression fractures). Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5860 and is authorized under FDA application ANDA075710.

Identification & Billing

NDC Package Code
54868-5860-1
Package Description
3 BOX in 1 CONTAINER / 4 BLISTER PACK in 1 BOX / 1 TABLET in 1 BLISTER PACK
Product Code
54868-5860
11-Digit Billing Format
54868586001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Alendronate Sodium
Dosage Form
-
Usage Information
Alendronate sodium tablets are indicated for:Treatment and prevention of osteoporosis in postmenopausal womenFor the treatment of osteoporosis, alendronate sodium tablets increase bone mass and reduce the incidence of fractures, including those of the hip and spine (vertebral compression fractures). Osteoporosis may be confirmed by the finding of low bone mass (for example, at least 2 standard deviations below the premenopausal mean) or by the presence or history of osteoporotic fracture (see CLINICAL PHARMACOLOGY, Pharmacodynamics).For the prevention of osteoporosis, alendronate sodium tablets may be considered in postmenopausal women who are at risk of developing osteoporosis and for whom the desired clinical outcome is to maintain bone mass and to reduce the risk of future fracture. Bone loss is particularly rapid in postmenopausal women younger than age 60. Risk factors often associated with the development of postmenopausal osteoporosis include early menopause; moderately low bone mass (for example, at least 1 standard deviation below the mean for healthy young adult women); thin body build; Caucasian or Asian race; and family history of osteoporosis. The presence of such risk factors may be important when considering the use of alendronate sodium for prevention of osteoporosis. Treatment to increase bone mass in men with osteoporosisTreatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density (see PRECAUTIONS, Glucocorticoid-induced osteoporosis). Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.Treatment of Paget’s disease of bone in men and womenTreatment is indicated in patients with Paget’s disease of bone having alkaline phosphatase at least two times the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease.The safety and effectiveness of alendronate sodium tablets for the treatment of osteoporosis are based on clinical data of four years duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA075710
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-07-2008
Listing Expiration
12-31-2017
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (54868-5860). Click a package code to view its specific billing and regulatory data.

54868-5860-0
4 BLISTER PACK in 1 BOX / 1 TABLET in 1 BLISTER PACK

* 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 54868-5860-1 identifies a specific commercial package of 3 box in 1 container / 4 blister pack in 1 box / 1 tablet in 1 blister pack of Alendronate Sodium, labeled by Physicians Total Care, 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 Physicians Total Care, Inc. on February 07, 2008. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868586001. 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)
54868-5860-1
11-Digit CMS (5-4-2)
54868-5860-01

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