Ibandronate Sodium
NDC Package 23155-162-31

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 discontinued by the firm.

Ibandronate Sodium is ibandronate is used to prevent and treat certain types of bone loss (osteoporosis). Marketed by Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc., this product is identified by NDC 23155-162 and is authorized under FDA application ANDA203987.

Identification & Billing

NDC Package Code
23155-162-31
Package Description
3 mL in 1 VIAL, GLASS
Product Code
23155-162
11-Digit Billing Format
23155016231

Clinical Specifications

Proprietary Name
Ibandronate Sodium
Dosage Form
-
Usage Information
Ibandronate is used to prevent and treat certain types of bone loss (osteoporosis). Osteoporosis causes bones to become thinner and break more easily. Your chance of developing osteoporosis increases after menopause, as you age, or if you take corticosteroid medications (such as prednisone) for long periods. This medication works by slowing bone loss to help maintain strong bones and reduce the risk of broken bones (fractures). Ibandronate belongs to a class of medications called bisphosphonates.

Regulatory & Marketing

Labeler Name
Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.
FDA Application #
ANDA203987
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-04-2014
End Marketing Date
11-03-2014
Listing Expiration
11-03-2014
Exclude Flag
D
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 23155-162-31 identifies a specific commercial package of 3 ml in 1 vial, glass of Ibandronate Sodium, labeled by Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals 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 Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc. on September 04, 2014. The current certification is valid through November 03, 2014.

What are the primary indications for this medication?

Ibandronate is used to prevent and treat certain types of bone loss (osteoporosis). Osteoporosis causes bones to become thinner and break more easily. Your chance of developing osteoporosis increases after menopause, as you age, or if you take corticosteroid medications (such as prednisone) for long periods. This medication works by slowing bone loss to help maintain strong bones and reduce the risk of broken bones (fractures). Ibandronate belongs to a class of medications called bisphosphonates.

How is this Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 23155016231. 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)
23155-162-31
11-Digit CMS (5-4-2)
23155-0162-31

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