Fosamax Plus D
NDC Package 54868-5480-0

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.

Fosamax Plus D is a medication used to treat certain types of bone loss (osteoporosis) and to increase bone mass. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5480 and is authorized under FDA application NDA021762.

Identification & Billing

NDC Package Code
54868-5480-0
Package Description
1 BLISTER PACK in 1 CARTON / 4 TABLET in 1 BLISTER PACK
Product Code
54868-5480
11-Digit Billing Format
54868548000
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 904492 - alendronate sodium 70 MG / cholecalciferol 2800 UNT Oral Tablet
  • RxCUI: 904492 - alendronic acid 70 MG / cholecalciferol 2800 UNT Oral Tablet
  • RxCUI: 904492 - alendronic acid 70 MG (as alendronate sodium 91.4 MG) / cholecalciferol 2800 UNT Oral Tablet
  • RxCUI: 904492 - alendronic acid 70 MG / vitamin D3 2800 UNT Oral Tablet
  • RxCUI: 904495 - FOSAMAX PLUS D 70 MG / 2800 UNT Oral Tablet

Clinical Specifications

Proprietary Name
Fosamax Plus D
Dosage Form
-
Usage Information
This medication is used to treat certain types of bone loss (osteoporosis) and to increase bone mass. 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 product is a combination of two medicines: alendronate and cholecalciferol (vitamin D3). Alendronate works by slowing bone loss to help maintain strong bones and reduce the risk of broken bones (fractures). It belongs to a class of medications called bisphosphonates. Vitamin D3 helps your body absorb calcium and is necessary for building healthy bones.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA021762
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-30-2005
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 54868-5480-0 identifies a specific commercial package of 1 blister pack in 1 carton / 4 tablet in 1 blister pack of Fosamax Plus D, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 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 Physicians Total Care, Inc. on November 30, 2005. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

This medication is used to treat certain types of bone loss (osteoporosis) and to increase bone mass. 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 product is a combination of two medicines: alendronate and cholecalciferol (vitamin D3). Alendronate works by slowing bone loss to help maintain strong bones and reduce the risk of broken bones (fractures). It belongs to a class of medications called bisphosphonates. Vitamin D3 helps your body absorb calcium and is necessary for building healthy bones.

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: 54868548000. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (5-4-1)
54868-5480-0
11-Digit CMS (5-4-2)
54868-5480-00

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