Irbesartan
NDC Package 42291-357-30

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Irbesartan is used to treat high blood pressure (hypertension) and to help protect the kidneys from damage due to diabetes. Marketed by Avkare, Inc., this product is identified by NDC 42291-357 and is authorized under FDA application ANDA204774.

Identification & Billing

NDC Package Code
42291-357-30
Package Description
30 TABLET in 1 BOTTLE
Product Code
42291-357
11-Digit Billing Format
42291035730

Clinical Specifications

Proprietary Name
Irbesartan
Dosage Form
-
Usage Information
Irbesartan is used to treat high blood pressure (hypertension) and to help protect the kidneys from damage due to diabetes. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Irbesartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). It works by relaxing blood vessels so that blood can flow more easily.

Regulatory & Marketing

Labeler Name
Avkare, Inc.
FDA Application #
ANDA204774
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-06-2016
End Marketing Date
08-22-2017
Listing Expiration
08-22-2017
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (42291-357). Click a package code to view its specific billing and regulatory data.

42291-357-90
90 TABLET in 1 BOTTLE

* 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 42291-357-30 identifies a specific commercial package of 30 tablet in 1 bottle of Irbesartan, labeled by Avkare, 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 Avkare, Inc. on October 06, 2016. The current certification is valid through August 22, 2017.

What are the primary indications for this medication?

Irbesartan is used to treat high blood pressure (hypertension) and to help protect the kidneys from damage due to diabetes. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Irbesartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). It works by relaxing blood vessels so that blood can flow more easily.

How is this Avkare, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42291035730. 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)
42291-357-30
11-Digit CMS (5-4-2)
42291-0357-30

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