irbesartan

Generic: irbesartan

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

Drug Facts

Product Profile

Brand Name irbesartan
Generic Name irbesartan
Labeler novadoz pharmaceuticals llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

irbesartan 300 mg/1

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-329
Product ID 72205-329_1f98fd95-e564-45b3-947f-45eba77f2af5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219539
Listing Expiration 2026-12-31
Marketing Start 2025-11-04

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 72205329
Hyphenated Format 72205-329

Supplemental Identifiers

RxCUI
200094 200095 200096
UPC
0372205327993 0372205327115 0372205328303 0372205328051 0372205329997 0372205329904 0372205328990 0372205329300 0372205327900 0372205328105 0372205328907 0372205329119 0372205327054 0372205327306 0372205329058
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 ANDA219539 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (72205-329-05)
  • 10 BLISTER PACK in 1 CARTON (72205-329-06) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (72205-329-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (72205-329-90)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (72205-329-99)
source: ndc

Packages (5)

72205-329-05 500 TABLET, FILM COATED in 1 BOTTLE (72205-329-05) 72205-329-06 10 BLISTER PACK in 1 CARTON (72205-329-06) / 10 TABLET, FILM COATED in 1 BLISTER PACK 72205-329-30 30 TABLET, FILM COATED in 1 BOTTLE (72205-329-30) 72205-329-90 90 TABLET, FILM COATED in 1 BOTTLE (72205-329-90) 72205-329-99 1000 TABLET, FILM COATED in 1 BOTTLE (72205-329-99)

Ingredients (1)

irbesartan (300 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": "1f98fd95-e564-45b3-947f-45eba77f2af5", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0372205327993", "0372205327115", "0372205328303", "0372205328051", "0372205329997", "0372205329904", "0372205328990", "0372205329300", "0372205327900", "0372205328105", "0372205328907", "0372205329119", "0372205327054", "0372205327306", "0372205329058"], "unii": ["J0E2756Z7N"], "rxcui": ["200094", "200095", "200096"], "spl_set_id": ["1f98fd95-e564-45b3-947f-45eba77f2af5"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (72205-329-05)", "package_ndc": "72205-329-05", "marketing_start_date": "20251107"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (72205-329-06)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "72205-329-06", "marketing_start_date": "20251107"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72205-329-30)", "package_ndc": "72205-329-30", "marketing_start_date": "20251107"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (72205-329-90)", "package_ndc": "72205-329-90", "marketing_start_date": "20251107"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (72205-329-99)", "package_ndc": "72205-329-99", "marketing_start_date": "20251107"}], "brand_name": "Irbesartan", "product_id": "72205-329_1f98fd95-e564-45b3-947f-45eba77f2af5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "72205-329", "generic_name": "Irbesartan", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Irbesartan", "active_ingredients": [{"name": "IRBESARTAN", "strength": "300 mg/1"}], "application_number": "ANDA219539", "marketing_category": "ANDA", "marketing_start_date": "20251104", "listing_expiration_date": "20261231"}