irbesartan

Generic: irbesartan

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name irbesartan
Generic Name irbesartan
Labeler avkare
Dosage Form TABLET
Routes
ORAL
Active Ingredients

irbesartan 75 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-940
Product ID 42291-940_3e89b142-2fd6-d340-e063-6294a90a5208
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203534
Listing Expiration 2026-12-31
Marketing Start 2025-02-06

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 42291940
Hyphenated Format 42291-940

Supplemental Identifiers

RxCUI
200094 200095 200096
UPC
0342291941908 0342291940901 0342291942905
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 ANDA203534 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (42291-940-90)
source: ndc

Packages (1)

42291-940-90 90 TABLET in 1 BOTTLE (42291-940-90)

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": "3e89b142-2fd6-d340-e063-6294a90a5208", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0342291941908", "0342291940901", "0342291942905"], "unii": ["J0E2756Z7N"], "rxcui": ["200094", "200095", "200096"], "spl_set_id": ["2d80abcb-c995-82bc-e063-6294a90aa530"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["AvKARE"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (42291-940-90)", "package_ndc": "42291-940-90", "marketing_start_date": "20250206"}], "brand_name": "IRBESARTAN", "product_id": "42291-940_3e89b142-2fd6-d340-e063-6294a90a5208", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "42291-940", "generic_name": "IRBESARTAN", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IRBESARTAN", "active_ingredients": [{"name": "IRBESARTAN", "strength": "75 mg/1"}], "application_number": "ANDA203534", "marketing_category": "ANDA", "marketing_start_date": "20250206", "listing_expiration_date": "20261231"}