Irbesartan
NDC Package 64220-430-03

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 Zhejiang Huahai Pharmaceutical Co., Ltd., this product is identified by NDC 64220-430 and is authorized under FDA application ANDA203071.

Identification & Billing

NDC Package Code
64220-430-03
Package Description
500 TABLET in 1 BOTTLE
Product Code
64220-430
11-Digit Billing Format
64220043003

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
Zhejiang Huahai Pharmaceutical Co., Ltd.
FDA Application #
ANDA203071
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-27-2012
End Marketing Date
01-01-2015
Listing Expiration
01-01-2015
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 (64220-430). Click a package code to view its specific billing and regulatory data.

64220-430-01
30 TABLET in 1 BOTTLE
64220-430-02
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 64220-430-03 identifies a specific commercial package of 500 tablet in 1 bottle of Irbesartan, labeled by Zhejiang Huahai Pharmaceutical Co., Ltd.. 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 Zhejiang Huahai Pharmaceutical Co., Ltd. on September 27, 2012. The current certification is valid through January 01, 2015.

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 Zhejiang Huahai Pharmaceutical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64220043003. 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)
64220-430-03
11-Digit CMS (5-4-2)
64220-0430-03

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