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  5. NDC Package Code: 65597-114-10 Tribenzor

NDC Package 65597-114-10 Tribenzor

Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
65597-114-10
Package Description:
10 BLISTER PACK in 1 BOX / 10 TABLET, FILM COATED in 1 BLISTER PACK
Product Code:
65597-114
Proprietary Name:
Tribenzor
Non-Proprietary Name:
Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide
Substance Name:
Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil
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.
11-Digit NDC Billing Format:
65597011410
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Daiichi Sankyo, Inc.
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • AMLODIPINE BESYLATE 5 mg/1
  • HYDROCHLOROTHIAZIDE 12.5 mg/1
  • OLMESARTAN MEDOXOMIL 20 mg/1
    • Pharmacologic Class(es):
  • Angiotensin 2 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Angiotensin 2 Receptor Blocker - [EPC] (Established Pharmacologic Class)
  • Calcium Channel Antagonists - [MoA] (Mechanism of Action)
  • Calcium Channel Blocker - [EPC] (Established Pharmacologic Class)
  • Cytochrome P450 3A Inhibitors - [MoA] (Mechanism of Action)
  • Dihydropyridine Calcium Channel Blocker - [EPC] (Established Pharmacologic Class)
  • Dihydropyridines - [CS]
  • Increased Diuresis - [PE] (Physiologic Effect)
  • Thiazide Diuretic - [EPC] (Established Pharmacologic Class)
  • Thiazides - [CS]
    • Sample Package:
    No
    FDA Application Number:
    NDA200175
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    07-31-2010
    End Marketing Date:
    08-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    65597-114-077 TABLET, FILM COATED in 1 BOTTLE
    65597-114-3030 TABLET, FILM COATED in 1 BOTTLE
    65597-114-707 TABLET, FILM COATED in 1 BLISTER PACK
    65597-114-9090 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65597-114-10?

    The NDC Packaged Code 65597-114-10 is assigned to a package of 10 blister pack in 1 box / 10 tablet, film coated in 1 blister pack of Tribenzor, a human prescription drug labeled by Daiichi Sankyo, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 65597-114 included in the NDC Directory?

    Yes, Tribenzor with product code 65597-114 is active and included in the NDC Directory. The product was first marketed by Daiichi Sankyo, Inc. on July 31, 2010.

    What is the 11-digit format for NDC 65597-114-10?

    The 11-digit format is 65597011410. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-265597-114-105-4-265597-0114-10