irbesartan and hydrochlorothiazide

Generic: irbesartan and hydrochlorothiazide

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

hydrochlorothiazide 25 mg/1, irbesartan 300 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-631
Product ID 65862-631_6f7c3d7b-9b7c-447e-8763-f68a55ce4b91
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203630
Listing Expiration 2026-12-31
Marketing Start 2016-03-31

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 65862631
Hyphenated Format 65862-631

Supplemental Identifiers

RxCUI
310792 310793 485471
UPC
0365862630308 0365862629302 0365862631305
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 ANDA203630 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 300 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (65862-631-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-631-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (65862-631-90)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65862-631-99)
source: ndc

Packages (4)

65862-631-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-631-05) 65862-631-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-631-30) 65862-631-90 90 TABLET, FILM COATED in 1 BOTTLE (65862-631-90) 65862-631-99 1000 TABLET, FILM COATED in 1 BOTTLE (65862-631-99)

Ingredients (2)

hydrochlorothiazide (25 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": "6f7c3d7b-9b7c-447e-8763-f68a55ce4b91", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "upc": ["0365862630308", "0365862629302", "0365862631305"], "unii": ["0J48LPH2TH", "J0E2756Z7N"], "rxcui": ["310792", "310793", "485471"], "spl_set_id": ["466dd0d2-9815-4c3e-b66b-d0732b3ba8e9"], "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": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-631-05)", "package_ndc": "65862-631-05", "marketing_start_date": "20160331"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-631-30)", "package_ndc": "65862-631-30", "marketing_start_date": "20160331"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65862-631-90)", "package_ndc": "65862-631-90", "marketing_start_date": "20160331"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-631-99)", "package_ndc": "65862-631-99", "marketing_start_date": "20160331"}], "brand_name": "Irbesartan and Hydrochlorothiazide", "product_id": "65862-631_6f7c3d7b-9b7c-447e-8763-f68a55ce4b91", "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": "65862-631", "generic_name": "Irbesartan and Hydrochlorothiazide", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Irbesartan and Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "25 mg/1"}, {"name": "IRBESARTAN", "strength": "300 mg/1"}], "application_number": "ANDA203630", "marketing_category": "ANDA", "marketing_start_date": "20160331", "listing_expiration_date": "20261231"}