tribenzor

Generic: olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide

Labeler: cosette pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tribenzor
Generic Name olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Labeler cosette pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amlodipine besylate 10 mg/1, hydrochlorothiazide 25 mg/1, olmesartan medoxomil 40 mg/1

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0878
Product ID 0713-0878_004953ba-fe11-03eb-e063-6394a90a638c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA200175
Listing Expiration 2026-12-31
Marketing Start 2022-09-01

Pharmacologic Class

Established (EPC)
thiazide diuretic [epc]
Chemical Structure
thiazides [cs]
Physiologic Effect
increased diuresis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07130878
Hyphenated Format 0713-0878

Supplemental Identifiers

RxCUI
999967 999971 999986 999990 999991 999995 999996 1000000 1000001 1000005
UPC
0307130876308 0307130874304 0307130877305 0307130878302 0307130875301
UNII
0J48LPH2TH 864V2Q084H 6M97XTV3HD
NUI
N0000175359 N0000175419 M0471776

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tribenzor (source: ndc)
Generic Name olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide (source: ndc)
Application Number NDA200175 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
  • 25 mg/1
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0713-0878-30)
source: ndc

Packages (1)

Ingredients (3)

amlodipine besylate (10 mg/1) hydrochlorothiazide (25 mg/1) olmesartan medoxomil (40 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "004953ba-fe11-03eb-e063-6394a90a638c", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0307130876308", "0307130874304", "0307130877305", "0307130878302", "0307130875301"], "unii": ["0J48LPH2TH", "864V2Q084H", "6M97XTV3HD"], "rxcui": ["999967", "999971", "999986", "999990", "999991", "999995", "999996", "1000000", "1000001", "1000005"], "spl_set_id": ["2f56d0bc-236b-41a0-9fc0-21cdfea8d890"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0713-0878-30)", "package_ndc": "0713-0878-30", "marketing_start_date": "20220901"}], "brand_name": "Tribenzor", "product_id": "0713-0878_004953ba-fe11-03eb-e063-6394a90a638c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["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]"], "product_ndc": "0713-0878", "generic_name": "olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tribenzor", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "10 mg/1"}, {"name": "HYDROCHLOROTHIAZIDE", "strength": "25 mg/1"}, {"name": "OLMESARTAN MEDOXOMIL", "strength": "40 mg/1"}], "application_number": "NDA200175", "marketing_category": "NDA", "marketing_start_date": "20220901", "listing_expiration_date": "20261231"}