irbesartan and hydrochlorothiazide (0093-8238)

Drug Facts

Product Profile

Brand Name irbesartan and hydrochlorothiazide

Generic Name irbesartan and hydrochlorothiazide

Labeler teva pharmaceuticals usa, inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

hydrochlorothiazide 12.5 mg/1, irbesartan 150 mg/1

Manufacturer

Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-8238

Product ID 0093-8238_af80b0d1-ba9d-4d3c-849c-6c7c1a7cfade

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA077369

Listing Expiration 2027-12-31

Marketing Start 2013-01-24

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 00938238

Hyphenated Format 0093-8238

Supplemental Identifiers

RxCUI

310792 310793

UPC

0300938238569

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 ANDA077369 (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 (0093-8238-56)
90 TABLET, FILM COATED in 1 BOTTLE (0093-8238-98)

source: ndc

Packages (2)

0093-8238-56 30 TABLET, FILM COATED in 1 BOTTLE (0093-8238-56) 0093-8238-98 90 TABLET, FILM COATED in 1 BOTTLE (0093-8238-98)

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": "af80b0d1-ba9d-4d3c-849c-6c7c1a7cfade", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "upc": ["0300938238569"], "unii": ["0J48LPH2TH", "J0E2756Z7N"], "rxcui": ["310792", "310793"], "spl_set_id": ["83f4acc1-697a-4770-b554-1b9a8fb5de74"], "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": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0093-8238-56)", "package_ndc": "0093-8238-56", "marketing_start_date": "20130124"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (0093-8238-98)", "package_ndc": "0093-8238-98", "marketing_start_date": "20130220"}], "brand_name": "Irbesartan and Hydrochlorothiazide", "product_id": "0093-8238_af80b0d1-ba9d-4d3c-849c-6c7c1a7cfade", "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": "0093-8238", "generic_name": "Irbesartan and Hydrochlorothiazide", "labeler_name": "Teva 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": "ANDA077369", "marketing_category": "ANDA", "marketing_start_date": "20130124", "listing_expiration_date": "20271231"}