olmesartan medoxomil and hydrochlorothiazide

Generic: olmesartan medoxomil and hydrochlorothiazide

Labeler: aurobindo pharma 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 aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-780
Product ID 65862-780_c29037bc-5702-437f-9da3-aa902291dc57
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205391
Listing Expiration 2026-12-31
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 65862780
Hyphenated Format 65862-780

Supplemental Identifiers

RxCUI
403853 403854 403855
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 ANDA205391 (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 (65862-780-30)
  • 10 BLISTER PACK in 1 CARTON (65862-780-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-780-10)
  • 90 TABLET, FILM COATED in 1 BOTTLE (65862-780-90)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65862-780-99)
source: ndc

Packages (4)

65862-780-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-780-30) 65862-780-78 10 BLISTER PACK in 1 CARTON (65862-780-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-780-10) 65862-780-90 90 TABLET, FILM COATED in 1 BOTTLE (65862-780-90) 65862-780-99 1000 TABLET, FILM COATED in 1 BOTTLE (65862-780-99)

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": "c29037bc-5702-437f-9da3-aa902291dc57", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "unii": ["0J48LPH2TH", "6M97XTV3HD"], "rxcui": ["403853", "403854", "403855"], "spl_set_id": ["744c1785-42b2-46a5-b0f4-2887a9ec2051"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-780-30)", "package_ndc": "65862-780-30", "marketing_start_date": "20170424"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-780-78)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-780-10)", "package_ndc": "65862-780-78", "marketing_start_date": "20170424"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65862-780-90)", "package_ndc": "65862-780-90", "marketing_start_date": "20170424"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-780-99)", "package_ndc": "65862-780-99", "marketing_start_date": "20170424"}], "brand_name": "Olmesartan Medoxomil and Hydrochlorothiazide", "product_id": "65862-780_c29037bc-5702-437f-9da3-aa902291dc57", "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": "65862-780", "generic_name": "Olmesartan Medoxomil and Hydrochlorothiazide", "labeler_name": "Aurobindo Pharma 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": "ANDA205391", "marketing_category": "ANDA", "marketing_start_date": "20170424", "listing_expiration_date": "20261231"}