irbesartan

Generic: irbesartan

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

irbesartan 150 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-441
Product ID 50268-441_3c1c8771-3bbc-7b5a-e063-6394a90a192c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202910
Listing Expiration 2026-12-31
Marketing Start 2023-08-08

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 50268441
Hyphenated Format 50268-441

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
  • 150 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-441-15) / 1 TABLET in 1 BLISTER PACK (50268-441-11)
source: ndc

Packages (1)

50268-441-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-441-15) / 1 TABLET in 1 BLISTER PACK (50268-441-11)

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": "3c1c8771-3bbc-7b5a-e063-6394a90a192c", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["J0E2756Z7N"], "rxcui": ["200094", "200095", "200096"], "spl_set_id": ["61b60f94-35e6-b90b-08ce-fbb2fe011f34"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-441-15)  / 1 TABLET in 1 BLISTER PACK (50268-441-11)", "package_ndc": "50268-441-15", "marketing_start_date": "20230808"}], "brand_name": "Irbesartan", "product_id": "50268-441_3c1c8771-3bbc-7b5a-e063-6394a90a192c", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "50268-441", "generic_name": "Irbesartan", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Irbesartan", "active_ingredients": [{"name": "IRBESARTAN", "strength": "150 mg/1"}], "application_number": "ANDA202910", "marketing_category": "ANDA", "marketing_start_date": "20230808", "listing_expiration_date": "20261231"}