olmesartan medoxomil and hydrochlorothiazide (16729-367)

Drug Facts

Product Profile

Brand Name olmesartan medoxomil and hydrochlorothiazide

Generic Name olmesartan medoxomil and hydrochlorothiazide

Labeler accord healthcare inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

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

Manufacturer

Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-367

Product ID 16729-367_424dfa88-8ad1-1ec4-e063-6394a90a8dcf

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA209281

Listing Expiration 2026-12-31

Marketing Start 2020-09-03

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 16729367

Hyphenated Format 16729-367

Supplemental Identifiers

RxCUI

403853 403854 403855

UPC

0316729368100 0316729366106 0316729367103

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 ANDA209281 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

12.5 mg/1
40 mg/1

source: ndc

Packaging

90 TABLET, FILM COATED in 1 BOTTLE (16729-367-15)

source: ndc

Packages (1)

16729-367-15 90 TABLET, FILM COATED in 1 BOTTLE (16729-367-15)

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": "424dfa88-8ad1-1ec4-e063-6394a90a8dcf", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0316729368100", "0316729366106", "0316729367103"], "unii": ["0J48LPH2TH", "6M97XTV3HD"], "rxcui": ["403853", "403854", "403855"], "spl_set_id": ["d858a6de-dda5-4bcd-a255-5723d01d896f"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (16729-367-15)", "package_ndc": "16729-367-15", "marketing_start_date": "20200903"}], "brand_name": "OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE", "product_id": "16729-367_424dfa88-8ad1-1ec4-e063-6394a90a8dcf", "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": "16729-367", "generic_name": "OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE", "labeler_name": "Accord Healthcare Inc.", "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": "ANDA209281", "marketing_category": "ANDA", "marketing_start_date": "20200903", "listing_expiration_date": "20261231"}