irbesartan and hydrochlorothiazide

Generic: irbesartan and hydrochlorothiazide

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name irbesartan and hydrochlorothiazide
Generic Name irbesartan and hydrochlorothiazide
Labeler macleods pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydrochlorothiazide 12.5 mg/1, irbesartan 300 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-058
Product ID 33342-058_f2ef667a-4871-4f28-a0b3-3f79fbbe180c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202414
Listing Expiration 2026-12-31
Marketing Start 2012-09-27

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 33342058
Hyphenated Format 33342-058

Supplemental Identifiers

RxCUI
310792 310793
UPC
0333342058102
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 ANDA202414 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
  • 300 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (33342-058-06) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (33342-058-07)
  • 90 TABLET, FILM COATED in 1 BOTTLE (33342-058-10)
  • 500 TABLET, FILM COATED in 1 BOTTLE (33342-058-15)
  • 9 BLISTER PACK in 1 CARTON (33342-058-39) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (5)

33342-058-06 3 BLISTER PACK in 1 CARTON (33342-058-06) / 10 TABLET, FILM COATED in 1 BLISTER PACK 33342-058-07 30 TABLET, FILM COATED in 1 BOTTLE (33342-058-07) 33342-058-10 90 TABLET, FILM COATED in 1 BOTTLE (33342-058-10) 33342-058-15 500 TABLET, FILM COATED in 1 BOTTLE (33342-058-15) 33342-058-39 9 BLISTER PACK in 1 CARTON (33342-058-39) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (2)

hydrochlorothiazide (12.5 mg/1) irbesartan (300 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": "f2ef667a-4871-4f28-a0b3-3f79fbbe180c", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "upc": ["0333342058102"], "unii": ["0J48LPH2TH", "J0E2756Z7N"], "rxcui": ["310792", "310793"], "spl_set_id": ["1898f438-4571-4aab-ae06-9bf1aabf0486"], "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": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (33342-058-06)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "33342-058-06", "marketing_start_date": "20120927"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (33342-058-07)", "package_ndc": "33342-058-07", "marketing_start_date": "20120927"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (33342-058-10)", "package_ndc": "33342-058-10", "marketing_start_date": "20120927"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (33342-058-15)", "package_ndc": "33342-058-15", "marketing_start_date": "20120927"}, {"sample": false, "description": "9 BLISTER PACK in 1 CARTON (33342-058-39)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "33342-058-39", "marketing_start_date": "20120927"}], "brand_name": "Irbesartan and Hydrochlorothiazide", "product_id": "33342-058_f2ef667a-4871-4f28-a0b3-3f79fbbe180c", "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": "33342-058", "generic_name": "Irbesartan and Hydrochlorothiazide", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Irbesartan and Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "IRBESARTAN", "strength": "300 mg/1"}], "application_number": "ANDA202414", "marketing_category": "ANDA", "marketing_start_date": "20120927", "listing_expiration_date": "20261231"}