Tribenzor Tablet, Film Coated
NDC Package 0713-0875-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Tribenzor (olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide) tablets is a medication used to treat high blood pressure (hypertension). This formulation utilizes a tablet, film coated delivery system. Marketed by Cosette Pharmaceuticals, Inc., this product is identified by NDC 0713-0875 and is authorized under FDA application NDA200175.

Identification & Billing

NDC Package Code
0713-0875-30
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
0713-0875
11-Digit Billing Format
00713087530
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 1000000 - TRIBENZOR 40 MG / 5 MG / 12.5 MG Oral Tablet
  • RxCUI: 1000000 - amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]
  • RxCUI: 1000000 - Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]
  • RxCUI: 1000000 - Tribenzor 40/5/12.5 (olmesartan medoxomil / amlodipine (as amlodipine besylate) / HCTZ) Oral Tablet
  • RxCUI: 1000001 - olmesartan medoxomil 40 MG / amLODIPine 5 MG / hydroCHLOROthiazide 25 MG Oral Tablet

Clinical Specifications

Proprietary Name
Tribenzor
Non-Proprietary Name
Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide
Substance Name
Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Cosette Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA200175
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-01-2022
Listing Expiration
12-31-2026
Exclude Flag
N
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 0713-0875-30 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Tribenzor, a human prescription drug labeled by Cosette Pharmaceuticals, Inc.. This tablet, film coated is formulated for oral use and contains amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil 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 Cosette Pharmaceuticals, Inc. on September 01, 2022. The current certification is valid through December 31, 2026.

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 Cosette Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00713087530. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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 (4-4-2)
0713-0875-30
11-Digit CMS (5-4-2)
00713-0875-30

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