Tribenzor
NDC Package 65597-116-07
Package Information
Tribenzor is a medication used to treat high blood pressure (hypertension). Marketed by Daiichi Sankyo, Inc., this product is identified by NDC 65597-116 and is authorized under FDA application NDA200175.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 65597 - Daiichi Sankyo, Inc.
- 65597-116 - Tribenzor
- 65597-116-07 - 7 TABLET, FILM COATED in 1 BOTTLE
- 65597-116 - Tribenzor
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 (65597-116). Click a package code to view its specific billing and regulatory data.
* 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 65597-116-07 identifies a specific commercial package of 7 tablet, film coated in 1 bottle of Tribenzor, labeled by Daiichi Sankyo, 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 Daiichi Sankyo, Inc. on July 31, 2010. The current certification is valid through June 30, 2024.
What are the primary indications for this medication?
This product is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This product contains 3 medications: olmesartan, amlodipine, and hydrochlorothiazide. Olmesartan is an angiotensin receptor blocker (ARB) and amlodipine is a calcium channel blocker. They both work by relaxing blood vessels so blood can flow more easily. Hydrochlorothiazide is called a "water pill" (diuretic) and causes your body to get rid of extra salt and water by making more urine.
How is this Daiichi Sankyo, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 65597011607. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
