Ibandronate Sodium
NDC Package 42291-336-03

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 Avkare, Inc., this product is identified by NDC 42291-336 and is authorized under FDA application ANDA079003.

Identification & Billing

NDC Package Code
42291-336-03
Package Description
3 BLISTER PACK in 1 BOX / 1 TABLET in 1 BLISTER PACK (42291-336-11)
Product Code
42291-336
11-Digit Billing Format
42291033603
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
3 EA

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
Avkare, Inc.
FDA Application #
ANDA079003
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-04-2013
End Marketing Date
09-19-2016
Listing Expiration
09-19-2016
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 42291-336-03 identifies a specific commercial package of 3 blister pack in 1 box / 1 tablet in 1 blister pack (42291-336-11) of Ibandronate Sodium, labeled by Avkare, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 3 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 Avkare, Inc. on December 04, 2013. The current certification is valid through September 19, 2016.

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 Avkare, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42291033603. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 3 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)
42291-336-03
11-Digit CMS (5-4-2)
42291-0336-03

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