olmesartan medoxomil amlodipine and hydrochlorothiazide

Generic: olmesartan medoxomil amlodipine and hydrochlorothiazide

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olmesartan medoxomil amlodipine and hydrochlorothiazide
Generic Name olmesartan medoxomil amlodipine and hydrochlorothiazide
Labeler macleods pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amlodipine besylate 5 mg/1, hydrochlorothiazide 12.5 mg/1, olmesartan medoxomil 20 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-243
Product ID 33342-243_52c013e1-8c31-4bed-9241-e7845873ebe8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207088
Listing Expiration 2026-12-31
Marketing Start 2025-07-18

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 33342243
Hyphenated Format 33342-243

Supplemental Identifiers

RxCUI
999967 999986 999991 999996 1000001
UPC
0333342247070 0333342245076
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 olmesartan medoxomil amlodipine and hydrochlorothiazide (source: ndc)
Generic Name olmesartan medoxomil amlodipine and hydrochlorothiazide (source: ndc)
Application Number ANDA207088 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 12.5 mg/1
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (33342-243-07)
  • 90 TABLET, FILM COATED in 1 BOTTLE (33342-243-10)
source: ndc

Packages (2)

33342-243-07 30 TABLET, FILM COATED in 1 BOTTLE (33342-243-07) 33342-243-10 90 TABLET, FILM COATED in 1 BOTTLE (33342-243-10)

Ingredients (3)

amlodipine besylate (5 mg/1) hydrochlorothiazide (12.5 mg/1) olmesartan medoxomil (20 mg/1)

Linked Drug Pages (1)

Olmesartan medoxomil Amlodipine and Hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "52c013e1-8c31-4bed-9241-e7845873ebe8", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0333342247070", "0333342245076"], "unii": ["0J48LPH2TH", "864V2Q084H", "6M97XTV3HD"], "rxcui": ["999967", "999986", "999991", "999996", "1000001"], "spl_set_id": ["52c013e1-8c31-4bed-9241-e7845873ebe8"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (33342-243-07)", "package_ndc": "33342-243-07", "marketing_start_date": "20250718"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (33342-243-10)", "package_ndc": "33342-243-10", "marketing_start_date": "20250718"}], "brand_name": "Olmesartan medoxomil Amlodipine and Hydrochlorothiazide", "product_id": "33342-243_52c013e1-8c31-4bed-9241-e7845873ebe8", "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": "33342-243", "generic_name": "Olmesartan medoxomil Amlodipine and Hydrochlorothiazide", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olmesartan medoxomil Amlodipine and Hydrochlorothiazide", "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": "ANDA207088", "marketing_category": "ANDA", "marketing_start_date": "20250718", "listing_expiration_date": "20261231"}