irbesartan

Generic: irbesartan

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

Drug Facts

Product Profile

Brand Name irbesartan
Generic Name irbesartan
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

irbesartan 75 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-637
Product ID 65862-637_9e17df53-3757-4012-a76f-d1aa0053fda0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203081
Listing Expiration 2026-12-31
Marketing Start 2012-09-27

Pharmacologic Class

Established (EPC)
angiotensin 2 receptor blocker [epc]
Mechanism of Action
angiotensin 2 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862637
Hyphenated Format 65862-637

Supplemental Identifiers

RxCUI
200094 200095 200096
UPC
0365862637901
UNII
J0E2756Z7N
NUI
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 (source: ndc)
Generic Name irbesartan (source: ndc)
Application Number ANDA203081 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (65862-637-05)
  • 30 TABLET in 1 BOTTLE (65862-637-30)
  • 10 BLISTER PACK in 1 CARTON (65862-637-78) / 10 TABLET in 1 BLISTER PACK (65862-637-10)
  • 90 TABLET in 1 BOTTLE (65862-637-90)
source: ndc

Packages (4)

65862-637-05 500 TABLET in 1 BOTTLE (65862-637-05) 65862-637-30 30 TABLET in 1 BOTTLE (65862-637-30) 65862-637-78 10 BLISTER PACK in 1 CARTON (65862-637-78) / 10 TABLET in 1 BLISTER PACK (65862-637-10) 65862-637-90 90 TABLET in 1 BOTTLE (65862-637-90)

Ingredients (1)

irbesartan (75 mg/1)

Linked Drug Pages (1)

Irbesartan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9e17df53-3757-4012-a76f-d1aa0053fda0", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0365862637901"], "unii": ["J0E2756Z7N"], "rxcui": ["200094", "200095", "200096"], "spl_set_id": ["2113a901-2612-4557-b86d-3afc006fb8bb"], "pharm_class_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 in 1 BOTTLE (65862-637-05)", "package_ndc": "65862-637-05", "marketing_start_date": "20120927"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (65862-637-30)", "package_ndc": "65862-637-30", "marketing_start_date": "20120927"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-637-78)  / 10 TABLET in 1 BLISTER PACK (65862-637-10)", "package_ndc": "65862-637-78", "marketing_start_date": "20140922"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (65862-637-90)", "package_ndc": "65862-637-90", "marketing_start_date": "20120927"}], "brand_name": "Irbesartan", "product_id": "65862-637_9e17df53-3757-4012-a76f-d1aa0053fda0", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "65862-637", "generic_name": "Irbesartan", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Irbesartan", "active_ingredients": [{"name": "IRBESARTAN", "strength": "75 mg/1"}], "application_number": "ANDA203081", "marketing_category": "ANDA", "marketing_start_date": "20120927", "listing_expiration_date": "20261231"}