Irbesartan Powder
NDC Package 72023-0010-1

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Irbesartan powders is irbesartan is used to treat high blood pressure (hypertension) and to help protect the kidneys from damage due to diabetes. This formulation utilizes a powder delivery system. Marketed by Zhuhai Rundu Pharmaceutical Co., Ltd., this product is identified by NDC 72023-0010.

Identification & Billing

NDC Package Code
72023-0010-1
Package Description
1 BAG in 1 DRUM / 20 kg in 1 BAG
Product Code
72023-0010
11-Digit Billing Format
72023001001

Clinical Specifications

Proprietary Name
Irbesartan
Non-Proprietary Name
Irbesartan
Substance Name
Irbesartan
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
IRBESARTAN 1 kg/kg
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
Zhuhai Rundu Pharmaceutical Co., Ltd.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
10-01-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 72023-0010-1 identifies a specific commercial package of 1 bag in 1 drum / 20 kg in 1 bag of Irbesartan (UNFINISHED drug), a bulk ingredient labeled by Zhuhai Rundu Pharmaceutical Co., Ltd.. This powder is formulated for use and contains irbesartan 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 Zhuhai Rundu Pharmaceutical Co., Ltd. on October 01, 2024. The current certification is valid through December 31, 2026.

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 Zhuhai Rundu Pharmaceutical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72023001001. 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 (5-4-1)
72023-0010-1
11-Digit CMS (5-4-2)
72023-0010-01

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