benicar hct

Generic: olmesartan medoxomil-hydrochlorothiazide

Labeler: cosette pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name benicar hct
Generic Name olmesartan medoxomil-hydrochlorothiazide
Labeler cosette pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0864
Product ID 0713-0864_004953ba-fde0-03eb-e063-6394a90a638c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021532
Listing Expiration 2026-12-31
Marketing Start 2022-09-01

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 07130864
Hyphenated Format 0713-0864

Supplemental Identifiers

RxCUI
403853 403854 403855 847042 847055 847060
UPC
0307130863308 0307130865302 0307130864305
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 benicar hct (source: ndc)
Generic Name olmesartan medoxomil-hydrochlorothiazide (source: ndc)
Application Number NDA021532 (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, PLASTIC (0713-0864-30)
source: ndc

Packages (1)

0713-0864-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0864-30)

Ingredients (2)

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

Linked Drug Pages (1)

Benicar HCT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "004953ba-fde0-03eb-e063-6394a90a638c", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0307130863308", "0307130865302", "0307130864305"], "unii": ["0J48LPH2TH", "6M97XTV3HD"], "rxcui": ["403853", "403854", "403855", "847042", "847055", "847060"], "spl_set_id": ["881a1c32-c209-4038-9c5e-c5e46c6e0546"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0864-30)", "package_ndc": "0713-0864-30", "marketing_start_date": "20220901"}], "brand_name": "Benicar HCT", "product_id": "0713-0864_004953ba-fde0-03eb-e063-6394a90a638c", "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": "0713-0864", "generic_name": "olmesartan medoxomil-hydrochlorothiazide", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Benicar HCT", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "OLMESARTAN MEDOXOMIL", "strength": "40 mg/1"}], "application_number": "NDA021532", "marketing_category": "NDA", "marketing_start_date": "20220901", "listing_expiration_date": "20261231"}