65597-114 NDC - TRIBENZOR (OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE)

Drug Information

Product NDC: 65597-114

Proprietary Name: Tribenzor

Non Proprietary Name: olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide

Active Ingredient(s):
  • 5 mg/1 AMLODIPINE BESYLATE;
  • 12.5 mg/1 HYDROCHLOROTHIAZIDE;
  • 20 mg/1 OLMESARTAN MEDOXOMIL


Administration Route(s): ORAL

Dosage Form(s): TABLET, FILM COATED

Pharmacy Class(es):
  • Angiotensin 2 Receptor Antagonists [MoA];
  • Angiotensin 2 Receptor Blocker [EPC];
  • Calcium Channel Antagonists [MoA];
  • Calcium Channel Blocker [EPC];
  • Cytochrome P450 3A Inhibitors [MoA];
  • Dihydropyridine Calcium Channel Blocker [EPC];
  • Dihydropyridines [CS];
  • Increased Diuresis [PE];
  • Thiazide Diuretic [EPC];
  • Thiazides [CS]

Labeler Information

Labeler Name: Daiichi Sankyo, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA200175
Marketing Category: NDA
Start Marketing Date:7/31/2010
End Marketing Date:8/31/2024

Package Information

No. Package Code Package Description Billing Unit
165597-114-077 TABLET, FILM COATED in 1 BOTTLE (65597-114-07)
265597-114-1010 BLISTER PACK in 1 BOX (65597-114-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
365597-114-3030 TABLET, FILM COATED in 1 BOTTLE (65597-114-30)EA
465597-114-707 TABLET, FILM COATED in 1 BLISTER PACK (65597-114-70)
565597-114-9090 TABLET, FILM COATED in 1 BOTTLE (65597-114-90)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC65597-114The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMETribenzorThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEolmesartan medoxomil / amlodipine besylate / hydrochlorothiazideThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, FILM COATEDThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE7/31/2010This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE8/31/2024This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA200175This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEDaiichi Sankyo, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH5; 12.5; 20 
ACTIVE INGRED UNITmg/1; mg/1; mg/1 
PHARM CLASSESAngiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS] 

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This page was last updated on: 2/1/2023