Binosto Tablet, Effervescent
NDC Package 70539-400-04

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

Package Information

Binosto (alendronate sodium) tablets is alendronate is used to prevent and treat certain types of bone loss (osteoporosis) in adults. This formulation utilizes a tablet, effervescent delivery system. Marketed by Radius Health, Inc., this product is identified by NDC 70539-400 and is authorized under FDA application NDA202344.

Identification & Billing

NDC Package Code
70539-400-04
Package Description
4 BLISTER PACK in 1 BOX / 1 TABLET, EFFERVESCENT in 1 BLISTER PACK (70539-400-00)
Product Code
70539-400
11-Digit Billing Format
70539040004
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
4 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Binosto
Non-Proprietary Name
Alendronate Sodium
Substance Name
Alendronate Sodium
Dosage Form
Tablet, Effervescent - A solid dosage form containing mixtures of acids (e.g., citric acid, tartaric acid) and sodium bicarbonate, which release carbon dioxide when dissolved in water; it is intended to be dissolved or dispersed in water before administration.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ALENDRONATE SODIUM 91.37 mg/1
Pharmacologic Class
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
Radius Health, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA202344
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-12-2012
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70539-400). Click a package code to view its specific billing and regulatory data.

70539-400-94
4 BLISTER PACK in 1 BOX / 1 TABLET, EFFERVESCENT in 1 BLISTER PACK (70539-400-00)

* 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 70539-400-04 identifies a specific commercial package of 4 blister pack in 1 box / 1 tablet, effervescent in 1 blister pack (70539-400-00) of Binosto, a human prescription drug labeled by Radius Health, Inc.. This tablet, effervescent is formulated for oral use and contains alendronate sodium 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 Radius Health, Inc. on March 12, 2012. The current certification is valid through December 31, 2027.

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 Radius Health, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70539040004. 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)
70539-400-04
11-Digit CMS (5-4-2)
70539-0400-04

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