irbesartan and hydrochlorothiazide (43547-331)

Drug Facts

Product Profile

Brand Name irbesartan and hydrochlorothiazide

Generic Name irbesartan and hydrochlorothiazide

Labeler solco healthcare us, llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

hydrochlorothiazide 12.5 mg/1, irbesartan 300 mg/1

Manufacturer

Solco Healthcare US, LLC

Identifiers & Regulatory

Product NDC 43547-331

Product ID 43547-331_3e6f512c-8ff3-40b0-bcd3-9bf9bf26a112

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA203072

Listing Expiration 2027-12-31

Marketing Start 2014-03-01

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 43547331

Hyphenated Format 43547-331

Supplemental Identifiers

RxCUI

310792 310793

UPC

0343547331030 0343547330033

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 ANDA203072 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

12.5 mg/1
300 mg/1

source: ndc

Packaging

30 TABLET in 1 BOTTLE (43547-331-03)
90 TABLET in 1 BOTTLE (43547-331-09)
500 TABLET in 1 BOTTLE (43547-331-50)

source: ndc

Packages (3)

43547-331-03 30 TABLET in 1 BOTTLE (43547-331-03) 43547-331-09 90 TABLET in 1 BOTTLE (43547-331-09) 43547-331-50 500 TABLET in 1 BOTTLE (43547-331-50)

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": "3e6f512c-8ff3-40b0-bcd3-9bf9bf26a112", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "upc": ["0343547331030", "0343547330033"], "unii": ["0J48LPH2TH", "J0E2756Z7N"], "rxcui": ["310792", "310793"], "spl_set_id": ["72fa8cd4-bc2a-4a7d-8feb-2d60e077d801"], "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": ["Solco Healthcare US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (43547-331-03)", "package_ndc": "43547-331-03", "marketing_start_date": "20140301"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (43547-331-09)", "package_ndc": "43547-331-09", "marketing_start_date": "20140301"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (43547-331-50)", "package_ndc": "43547-331-50", "marketing_start_date": "20140301"}], "brand_name": "Irbesartan and Hydrochlorothiazide", "product_id": "43547-331_3e6f512c-8ff3-40b0-bcd3-9bf9bf26a112", "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": "43547-331", "generic_name": "Irbesartan and Hydrochlorothiazide", "labeler_name": "Solco Healthcare US, LLC", "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": "ANDA203072", "marketing_category": "ANDA", "marketing_start_date": "20140301", "listing_expiration_date": "20271231"}