irbesartan and hydrochlorothiazide (46708-443)

Drug Facts

Product Profile

Brand Name irbesartan and hydrochlorothiazide

Generic Name irbesartan and hydrochlorothiazide

Labeler alembic pharmaceuticals limited

Dosage Form TABLET

Routes

ORAL

Active Ingredients

hydrochlorothiazide 12.5 mg/1, irbesartan 300 mg/1

Manufacturer

Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-443

Product ID 46708-443_bbfa2906-f126-40a2-a5c4-8cbe19388fcc

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA091370

Listing Expiration 2026-12-31

Marketing Start 2016-05-23

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 46708443

Hyphenated Format 46708-443

Supplemental Identifiers

RxCUI

310792 310793 485471

UPC

0346708442309 0346708444303 0346708443306

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 ANDA091370 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

12.5 mg/1
300 mg/1

source: ndc

Packaging

10 TABLET in 1 BLISTER PACK (46708-443-10)
30 TABLET in 1 BOTTLE (46708-443-30)
90 TABLET in 1 BOTTLE (46708-443-90)
1000 TABLET in 1 BOTTLE (46708-443-91)

source: ndc

Packages (4)

46708-443-10 10 TABLET in 1 BLISTER PACK (46708-443-10) 46708-443-30 30 TABLET in 1 BOTTLE (46708-443-30) 46708-443-90 90 TABLET in 1 BOTTLE (46708-443-90) 46708-443-91 1000 TABLET in 1 BOTTLE (46708-443-91)

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": "bbfa2906-f126-40a2-a5c4-8cbe19388fcc", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "upc": ["0346708442309", "0346708444303", "0346708443306"], "unii": ["0J48LPH2TH", "J0E2756Z7N"], "rxcui": ["310792", "310793", "485471"], "spl_set_id": ["9492a1cd-c012-4b43-931d-235220065e1e"], "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": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BLISTER PACK (46708-443-10)", "package_ndc": "46708-443-10", "marketing_start_date": "20160523"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (46708-443-30)", "package_ndc": "46708-443-30", "marketing_start_date": "20160523"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (46708-443-90)", "package_ndc": "46708-443-90", "marketing_start_date": "20160523"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (46708-443-91)", "package_ndc": "46708-443-91", "marketing_start_date": "20160523"}], "brand_name": "Irbesartan and Hydrochlorothiazide", "product_id": "46708-443_bbfa2906-f126-40a2-a5c4-8cbe19388fcc", "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": "46708-443", "generic_name": "Irbesartan and Hydrochlorothiazide", "labeler_name": "Alembic 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": "ANDA091370", "marketing_category": "ANDA", "marketing_start_date": "20160523", "listing_expiration_date": "20261231"}