irbesartan and hydrochlorothiazide

Generic: irbesartan and hydrochlorothiazide

Labeler: hisun pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name irbesartan and hydrochlorothiazide
Generic Name irbesartan and hydrochlorothiazide
Labeler hisun pharmaceuticals usa inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydrochlorothiazide 12.5 mg/1, irbesartan 150 mg/1

Manufacturer
Hisun Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 42658-141
Product ID 42658-141_2ca630bf-9b77-9da8-e063-6294a90a87b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207896
Listing Expiration 2026-12-31
Marketing Start 2025-01-01

Pharmacologic Class

Established (EPC)
thiazide diuretic [epc] angiotensin 2 receptor blocker [epc]
Mechanism of Action
angiotensin 2 receptor antagonists [moa]
Chemical Structure
thiazides [cs]
Physiologic Effect
increased diuresis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42658141
Hyphenated Format 42658-141

Supplemental Identifiers

RxCUI
310792 310793
UPC
0342658142016 0342658141019
UNII
0J48LPH2TH J0E2756Z7N
NUI
N0000175359 N0000175419 M0471776 N0000000070 N0000175561

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 irbesartan and hydrochlorothiazide (source: ndc)
Generic Name irbesartan and hydrochlorothiazide (source: ndc)
Application Number ANDA207896 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
  • 150 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (42658-141-01)
  • 90 TABLET, FILM COATED in 1 BOTTLE (42658-141-04)
  • 500 TABLET, FILM COATED in 1 BOTTLE (42658-141-07)
source: ndc

Packages (3)

42658-141-01 30 TABLET, FILM COATED in 1 BOTTLE (42658-141-01) 42658-141-04 90 TABLET, FILM COATED in 1 BOTTLE (42658-141-04) 42658-141-07 500 TABLET, FILM COATED in 1 BOTTLE (42658-141-07)

Ingredients (2)

hydrochlorothiazide (12.5 mg/1) irbesartan (150 mg/1)

Linked Drug Pages (1)

IRBESARTAN AND HYDROCHLOROTHIAZIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2ca630bf-9b77-9da8-e063-6294a90a87b9", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "upc": ["0342658142016", "0342658141019"], "unii": ["0J48LPH2TH", "J0E2756Z7N"], "rxcui": ["310792", "310793"], "spl_set_id": ["e6d11cd6-7204-4031-a6c5-8f6a33568ab4"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]", "Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Hisun Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (42658-141-01)", "package_ndc": "42658-141-01", "marketing_start_date": "20250101"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (42658-141-04)", "package_ndc": "42658-141-04", "marketing_start_date": "20250101"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (42658-141-07)", "package_ndc": "42658-141-07", "marketing_start_date": "20250101"}], "brand_name": "IRBESARTAN AND HYDROCHLOROTHIAZIDE", "product_id": "42658-141_2ca630bf-9b77-9da8-e063-6294a90a87b9", "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": "42658-141", "generic_name": "irbesartan and hydrochlorothiazide", "labeler_name": "Hisun Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IRBESARTAN AND HYDROCHLOROTHIAZIDE", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "IRBESARTAN", "strength": "150 mg/1"}], "application_number": "ANDA207896", "marketing_category": "ANDA", "marketing_start_date": "20250101", "listing_expiration_date": "20261231"}