irbesartan

Generic: irbesartan

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name irbesartan
Generic Name irbesartan
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

irbesartan 300 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-5241
Product ID 63629-5241_c125c1da-4dbf-404e-9057-131576e823a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202254
Listing Expiration 2026-12-31
Marketing Start 2012-09-27

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 636295241
Hyphenated Format 63629-5241

Supplemental Identifiers

RxCUI
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 ANDA202254 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (63629-5241-1)
  • 90 TABLET in 1 BOTTLE (63629-5241-2)
  • 28 TABLET in 1 BOTTLE (63629-5241-3)
  • 60 TABLET in 1 BOTTLE (63629-5241-4)
source: ndc

Packages (4)

63629-5241-1 30 TABLET in 1 BOTTLE (63629-5241-1) 63629-5241-2 90 TABLET in 1 BOTTLE (63629-5241-2) 63629-5241-3 28 TABLET in 1 BOTTLE (63629-5241-3) 63629-5241-4 60 TABLET in 1 BOTTLE (63629-5241-4)

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": "c125c1da-4dbf-404e-9057-131576e823a6", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["J0E2756Z7N"], "rxcui": ["200096"], "spl_set_id": ["44b72da1-4434-461f-8e3c-264ad46f85df"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (63629-5241-1)", "package_ndc": "63629-5241-1", "marketing_start_date": "20140219"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (63629-5241-2)", "package_ndc": "63629-5241-2", "marketing_start_date": "20140226"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE (63629-5241-3)", "package_ndc": "63629-5241-3", "marketing_start_date": "20211222"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (63629-5241-4)", "package_ndc": "63629-5241-4", "marketing_start_date": "20211222"}], "brand_name": "Irbesartan", "product_id": "63629-5241_c125c1da-4dbf-404e-9057-131576e823a6", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "63629-5241", "generic_name": "Irbesartan", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Irbesartan", "active_ingredients": [{"name": "IRBESARTAN", "strength": "300 mg/1"}], "application_number": "ANDA202254", "marketing_category": "ANDA", "marketing_start_date": "20120927", "listing_expiration_date": "20261231"}