olmesartan medoxomil-hydrochlorothiazide

Generic: olmesartan medoxomil-hydrochlorothiazide

Labeler: novadoz pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olmesartan medoxomil-hydrochlorothiazide
Generic Name olmesartan medoxomil-hydrochlorothiazide
Labeler novadoz pharmaceuticals llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-148
Product ID 72205-148_c8197eea-e990-4c0e-bc2d-f080bac8de17
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217398
Listing Expiration 2026-12-31
Marketing Start 2025-09-26

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 72205148
Hyphenated Format 72205-148

Supplemental Identifiers

RxCUI
403853 403854 403855
UPC
0372205148307 0372205147300 0372205147904 0372205148994 0372205149304 0372205148901 0372205147997 0372205149991 0372205149908
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-hydrochlorothiazide (source: ndc)
Generic Name olmesartan medoxomil-hydrochlorothiazide (source: ndc)
Application Number ANDA217398 (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 (72205-148-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (72205-148-90)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (72205-148-99)
source: ndc

Packages (3)

72205-148-30 30 TABLET, FILM COATED in 1 BOTTLE (72205-148-30) 72205-148-90 90 TABLET, FILM COATED in 1 BOTTLE (72205-148-90) 72205-148-99 1000 TABLET, FILM COATED in 1 BOTTLE (72205-148-99)

Ingredients (2)

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

Linked Drug Pages (1)

olmesartan medoxomil-hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c8197eea-e990-4c0e-bc2d-f080bac8de17", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0372205148307", "0372205147300", "0372205147904", "0372205148994", "0372205149304", "0372205148901", "0372205147997", "0372205149991", "0372205149908"], "unii": ["0J48LPH2TH", "6M97XTV3HD"], "rxcui": ["403853", "403854", "403855"], "spl_set_id": ["c8197eea-e990-4c0e-bc2d-f080bac8de17"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72205-148-30)", "package_ndc": "72205-148-30", "marketing_start_date": "20250930"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (72205-148-90)", "package_ndc": "72205-148-90", "marketing_start_date": "20250930"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (72205-148-99)", "package_ndc": "72205-148-99", "marketing_start_date": "20250930"}], "brand_name": "olmesartan medoxomil-hydrochlorothiazide", "product_id": "72205-148_c8197eea-e990-4c0e-bc2d-f080bac8de17", "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": "72205-148", "generic_name": "olmesartan medoxomil-hydrochlorothiazide", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "olmesartan medoxomil-hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "OLMESARTAN MEDOXOMIL", "strength": "40 mg/1"}], "application_number": "ANDA217398", "marketing_category": "ANDA", "marketing_start_date": "20250926", "listing_expiration_date": "20261231"}