irbesartan

Generic: irbesartan

Labeler: direct rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

irbesartan 300 mg/1

Manufacturer
direct rx

Identifiers & Regulatory

Product NDC 72189-270
Product ID 72189-270_2c290c08-d35e-21b4-e063-6394a90a73b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202910
Listing Expiration 2026-12-31
Marketing Start 2021-09-16

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 72189270
Hyphenated Format 72189-270

Supplemental Identifiers

RxCUI
200094 200095 200096
UNII
J0E2756Z7N
NUI
N0000000070 N0000175561

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 ANDA202910 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (72189-270-90)
source: ndc

Packages (1)

72189-270-90 90 TABLET in 1 BOTTLE (72189-270-90)

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": "2c290c08-d35e-21b4-e063-6394a90a73b9", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["J0E2756Z7N"], "rxcui": ["200094", "200095", "200096"], "spl_set_id": ["bfdf76ae-fedf-630c-e053-2995a90a9868"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["direct rx"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (72189-270-90)", "package_ndc": "72189-270-90", "marketing_start_date": "20210916"}], "brand_name": "IRBESARTAN", "product_id": "72189-270_2c290c08-d35e-21b4-e063-6394a90a73b9", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "72189-270", "generic_name": "IRBESARTAN", "labeler_name": "direct rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IRBESARTAN", "active_ingredients": [{"name": "IRBESARTAN", "strength": "300 mg/1"}], "application_number": "ANDA202910", "marketing_category": "ANDA", "marketing_start_date": "20210916", "listing_expiration_date": "20261231"}