irbesartan

Generic: irbesartan

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name irbesartan
Generic Name irbesartan
Labeler amneal pharmaceuticals llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

irbesartan 150 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-285
Product ID 65162-285_5d575575-9dee-4d65-962c-ca26b26ff85b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204740
Listing Expiration 2026-12-31
Marketing Start 2018-04-17

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 65162285
Hyphenated Format 65162-285

Supplemental Identifiers

RxCUI
200094 200095 200096
UPC
0365162284034 0365162285031 0365162286038
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 ANDA204740 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (65162-285-03)
  • 90 TABLET in 1 BOTTLE (65162-285-09)
  • 1000 TABLET in 1 BOTTLE (65162-285-11)
  • 500 TABLET in 1 BOTTLE (65162-285-50)
source: ndc

Packages (4)

65162-285-03 30 TABLET in 1 BOTTLE (65162-285-03) 65162-285-09 90 TABLET in 1 BOTTLE (65162-285-09) 65162-285-11 1000 TABLET in 1 BOTTLE (65162-285-11) 65162-285-50 500 TABLET in 1 BOTTLE (65162-285-50)

Ingredients (1)

irbesartan (150 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": "5d575575-9dee-4d65-962c-ca26b26ff85b", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0365162284034", "0365162285031", "0365162286038"], "unii": ["J0E2756Z7N"], "rxcui": ["200094", "200095", "200096"], "spl_set_id": ["8c9bb449-6341-4f24-9d38-6ca952e07122"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (65162-285-03)", "package_ndc": "65162-285-03", "marketing_start_date": "20180417"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (65162-285-09)", "package_ndc": "65162-285-09", "marketing_start_date": "20180417"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65162-285-11)", "package_ndc": "65162-285-11", "marketing_start_date": "20180417"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (65162-285-50)", "package_ndc": "65162-285-50", "marketing_start_date": "20180417"}], "brand_name": "Irbesartan", "product_id": "65162-285_5d575575-9dee-4d65-962c-ca26b26ff85b", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "65162-285", "generic_name": "Irbesartan", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Irbesartan", "active_ingredients": [{"name": "IRBESARTAN", "strength": "150 mg/1"}], "application_number": "ANDA204740", "marketing_category": "ANDA", "marketing_start_date": "20180417", "listing_expiration_date": "20261231"}