olmesartan medoxomil and hydrochlorothiazide

Generic: olmesartan medoxomil and hydrochlorothiazide

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

Drug Facts

Product Profile

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

hydrochlorothiazide 12.5 mg/1, olmesartan medoxomil 40 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-174
Product ID 33342-174_79da177b-5eeb-4d95-b949-251b7e8c948b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204801
Listing Expiration 2026-12-31
Marketing Start 2023-06-02

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 33342174
Hyphenated Format 33342-174

Supplemental Identifiers

RxCUI
403853 403854 403855
UPC
0333342175076 0333342173102 0333342173447 0333342175441 0333342174079 0333342174109 0333342173072 0333342175106 0333342174444
UNII
0J48LPH2TH 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 and hydrochlorothiazide (source: ndc)
Generic Name olmesartan medoxomil and hydrochlorothiazide (source: ndc)
Application Number ANDA204801 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (33342-174-07)
  • 90 TABLET, FILM COATED in 1 BOTTLE (33342-174-10)
  • 10 BLISTER PACK in 1 CARTON (33342-174-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 1000 TABLET, FILM COATED in 1 BOTTLE (33342-174-44)
source: ndc

Packages (4)

33342-174-07 30 TABLET, FILM COATED in 1 BOTTLE (33342-174-07) 33342-174-10 90 TABLET, FILM COATED in 1 BOTTLE (33342-174-10) 33342-174-12 10 BLISTER PACK in 1 CARTON (33342-174-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK 33342-174-44 1000 TABLET, FILM COATED in 1 BOTTLE (33342-174-44)

Ingredients (2)

hydrochlorothiazide (12.5 mg/1) olmesartan medoxomil (40 mg/1)

Linked Drug Pages (1)

OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "79da177b-5eeb-4d95-b949-251b7e8c948b", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0333342175076", "0333342173102", "0333342173447", "0333342175441", "0333342174079", "0333342174109", "0333342173072", "0333342175106", "0333342174444"], "unii": ["0J48LPH2TH", "6M97XTV3HD"], "rxcui": ["403853", "403854", "403855"], "spl_set_id": ["03ff0f7e-6aa1-4c38-8c9a-5f1c6a56c747"], "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 (33342-174-07)", "package_ndc": "33342-174-07", "marketing_start_date": "20230602"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (33342-174-10)", "package_ndc": "33342-174-10", "marketing_start_date": "20230602"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-174-12)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "33342-174-12", "marketing_start_date": "20230602"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (33342-174-44)", "package_ndc": "33342-174-44", "marketing_start_date": "20230602"}], "brand_name": "OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE", "product_id": "33342-174_79da177b-5eeb-4d95-b949-251b7e8c948b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "33342-174", "generic_name": "OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "OLMESARTAN MEDOXOMIL", "strength": "40 mg/1"}], "application_number": "ANDA204801", "marketing_category": "ANDA", "marketing_start_date": "20230602", "listing_expiration_date": "20261231"}