tribenzor
Generic: olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Labeler: cosette pharmaceuticals, inc.Drug Facts
Product Profile
Brand Name
tribenzor
Generic Name
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Labeler
cosette pharmaceuticals, inc.
Dosage Form
TABLET, FILM COATED
Routes
Active Ingredients
amlodipine besylate 5 mg/1, hydrochlorothiazide 12.5 mg/1, olmesartan medoxomil 20 mg/1
Manufacturer
Identifiers & Regulatory
Product NDC
0713-0874
Product ID
0713-0874_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)
Chemical Structure
Physiologic Effect
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
07130874
Hyphenated Format
0713-0874
Supplemental Identifiers
RxCUI
UPC
UNII
NUI
Packaging Origin
Original Packager
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
source: ndc
Resolved Composition
Strengths
- 5 mg/1
- 12.5 mg/1
- 20 mg/1
Packaging
- 30 TABLET, FILM COATED in 1 BOTTLE (0713-0874-30)
Packages (1)
Ingredients (3)
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 (0713-0874-30)", "package_ndc": "0713-0874-30", "marketing_start_date": "20220901"}], "brand_name": "Tribenzor", "product_id": "0713-0874_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": "0713-0874", "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": "5 mg/1"}, {"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "OLMESARTAN MEDOXOMIL", "strength": "20 mg/1"}], "application_number": "NDA200175", "marketing_category": "NDA", "marketing_start_date": "20220901", "listing_expiration_date": "20261231"}