olmesartan medoxomil and hydrochlorothiazide (43547-393)

Drug Facts

Product Profile

Brand Name olmesartan medoxomil and hydrochlorothiazide

Generic Name olmesartan medoxomil and hydrochlorothiazide

Labeler solco healthcare us, llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

hydrochlorothiazide 25 mg/1, olmesartan medoxomil 40 mg/1

Manufacturer

Solco Healthcare US, LLC

Identifiers & Regulatory

Product NDC 43547-393

Product ID 43547-393_23c860d3-1b9a-4113-bab4-b803492bf7d7

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207804

Listing Expiration 2027-12-31

Marketing Start 2017-04-24

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 43547393

Hyphenated Format 43547-393

Supplemental Identifiers

RxCUI

403853 403854 403855

UPC

0343547392093 0343547391096 0343547393090

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 ANDA207804 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

25 mg/1
40 mg/1

source: ndc

Packaging

30 TABLET in 1 BOTTLE (43547-393-03)
90 TABLET in 1 BOTTLE (43547-393-09)
1000 TABLET in 1 BOTTLE (43547-393-11)

source: ndc

Packages (3)

43547-393-03 30 TABLET in 1 BOTTLE (43547-393-03) 43547-393-09 90 TABLET in 1 BOTTLE (43547-393-09) 43547-393-11 1000 TABLET in 1 BOTTLE (43547-393-11)

Ingredients (2)

hydrochlorothiazide (25 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": "23c860d3-1b9a-4113-bab4-b803492bf7d7", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0343547392093", "0343547391096", "0343547393090"], "unii": ["0J48LPH2TH", "6M97XTV3HD"], "rxcui": ["403853", "403854", "403855"], "spl_set_id": ["bdca31d3-60b1-4659-aef7-56530b4f9039"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Solco Healthcare US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (43547-393-03)", "package_ndc": "43547-393-03", "marketing_start_date": "20170424"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (43547-393-09)", "package_ndc": "43547-393-09", "marketing_start_date": "20170424"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (43547-393-11)", "package_ndc": "43547-393-11", "marketing_start_date": "20170424"}], "brand_name": "OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE", "product_id": "43547-393_23c860d3-1b9a-4113-bab4-b803492bf7d7", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "43547-393", "generic_name": "olmesartan medoxomil and hydrochlorothiazide", "labeler_name": "Solco Healthcare US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "25 mg/1"}, {"name": "OLMESARTAN MEDOXOMIL", "strength": "40 mg/1"}], "application_number": "ANDA207804", "marketing_category": "ANDA", "marketing_start_date": "20170424", "listing_expiration_date": "20271231"}