olmesartan medoxomil and hydrochlorothiazide (67877-452)

Drug Facts

Product Profile

Brand Name olmesartan medoxomil and hydrochlorothiazide

Generic Name olmesartan medoxomil and hydrochlorothiazide

Labeler ascend laboratories, llc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

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

Manufacturer

Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-452

Product ID 67877-452_e6461d60-f7cc-454e-b54e-2bcbcb64e631

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207037

Listing Expiration 2026-12-31

Marketing Start 2025-05-01

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 67877452

Hyphenated Format 67877-452

Supplemental Identifiers

RxCUI

403853 403854 403855

UPC

0367877453903 0367877452906 0367877451305

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 ANDA207037 (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 (67877-452-30)
90 TABLET, FILM COATED in 1 BOTTLE (67877-452-90)

source: ndc

Packages (2)

67877-452-30 30 TABLET, FILM COATED in 1 BOTTLE (67877-452-30) 67877-452-90 90 TABLET, FILM COATED in 1 BOTTLE (67877-452-90)

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": "e6461d60-f7cc-454e-b54e-2bcbcb64e631", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0367877453903", "0367877452906", "0367877451305"], "unii": ["0J48LPH2TH", "6M97XTV3HD"], "rxcui": ["403853", "403854", "403855"], "spl_set_id": ["798fee33-51ad-45d0-82f3-09289304139f"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (67877-452-30)", "package_ndc": "67877-452-30", "marketing_start_date": "20250501"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (67877-452-90)", "package_ndc": "67877-452-90", "marketing_start_date": "20250501"}], "brand_name": "OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE", "product_id": "67877-452_e6461d60-f7cc-454e-b54e-2bcbcb64e631", "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": "67877-452", "generic_name": "OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE", "labeler_name": "Ascend Laboratories, LLC", "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": "ANDA207037", "marketing_category": "ANDA", "marketing_start_date": "20250501", "listing_expiration_date": "20261231"}