Fosamax Plus D Tablet
NDC Package 78206-137-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Fosamax Plus D (alendronate sodium and cholecalciferol) tablets is a medication used to treat certain types of bone loss (osteoporosis) and to increase bone mass. This formulation utilizes a tablet delivery system. Marketed by Organon Llc, this product is identified by NDC 78206-137 and is authorized under FDA application NDA021762.

Identification & Billing

NDC Package Code
78206-137-01
Package Description
4 TABLET in 1 BLISTER PACK
Product Code
78206-137
11-Digit Billing Format
78206013701
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
4 EA
RxNorm Crosswalk
  • RxCUI: 904462 - alendronate sodium 70 MG / cholecalciferol 5600 UNT Oral Tablet
  • RxCUI: 904462 - alendronic acid 70 MG / cholecalciferol 5600 UNT Oral Tablet
  • RxCUI: 904462 - alendronic acid 70 MG (as alendronate sodium 91.4 MG) / cholecalciferol 5600 UNT Oral Tablet
  • RxCUI: 904462 - alendronic acid 70 MG / vitamin D3 5,600 UNT Oral Tablet
  • RxCUI: 904465 - FOSAMAX PLUS D 70 MG / 5600 UNT Oral Tablet

Clinical Specifications

Proprietary Name
Fosamax Plus D
Non-Proprietary Name
Alendronate Sodium And Cholecalciferol
Substance Name
Alendronate Sodium; Cholecalciferol
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
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
Organon Llc
Product Type
Human Prescription Drug
FDA Application #
NDA021762
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-01-2021
Listing Expiration
12-31-2027
Exclude Flag
N
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 78206-137-01 identifies a specific commercial package of 4 tablet in 1 blister pack of Fosamax Plus D, a human prescription drug labeled by Organon Llc. This tablet is formulated for oral use and contains alendronate sodium; cholecalciferol as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Organon Llc on June 01, 2021. The current certification is valid through December 31, 2027.

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 Organon Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78206013701. 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 (5-3-2)
78206-137-01
11-Digit CMS (5-4-2)
78206-0137-01

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