irbesartan and hydrochlorothiazide (0054-0255)

Drug Facts

Product Profile

Brand Name irbesartan and hydrochlorothiazide

Generic Name irbesartan and hydrochlorothiazide

Labeler hikma pharmaceuticals usa inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

hydrochlorothiazide 12.5 mg/1, irbesartan 300 mg/1

Manufacturer

Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0255

Product ID 0054-0255_73e2946e-057a-4748-ac8c-13d48bb36599

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA090351

Listing Expiration 2026-12-31

Marketing Start 2012-10-15

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 00540255

Hyphenated Format 0054-0255

Supplemental Identifiers

RxCUI

310792 310793 485471

UPC

0300540255138 0300540255220 0300540254131

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 ANDA090351 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

12.5 mg/1
300 mg/1

source: ndc

Packaging

30 TABLET in 1 BOTTLE (0054-0255-13)
90 TABLET in 1 BOTTLE (0054-0255-22)

source: ndc

Packages (2)

0054-0255-13 30 TABLET in 1 BOTTLE (0054-0255-13) 0054-0255-22 90 TABLET in 1 BOTTLE (0054-0255-22)

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": "73e2946e-057a-4748-ac8c-13d48bb36599", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "upc": ["0300540255138", "0300540255220", "0300540254131"], "unii": ["0J48LPH2TH", "J0E2756Z7N"], "rxcui": ["310792", "310793", "485471"], "spl_set_id": ["17561aae-f0bc-4ffc-a007-985b17e9baf0"], "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": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (0054-0255-13)", "package_ndc": "0054-0255-13", "marketing_start_date": "20121015"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (0054-0255-22)", "package_ndc": "0054-0255-22", "marketing_start_date": "20121015"}], "brand_name": "Irbesartan and Hydrochlorothiazide", "product_id": "0054-0255_73e2946e-057a-4748-ac8c-13d48bb36599", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "0054-0255", "generic_name": "Irbesartan and Hydrochlorothiazide", "labeler_name": "Hikma 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": "300 mg/1"}], "application_number": "ANDA090351", "marketing_category": "ANDA", "marketing_start_date": "20121015", "listing_expiration_date": "20261231"}