irbesartan

Generic: irbesartan

Labeler: hisun pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name irbesartan
Generic Name irbesartan
Labeler hisun pharmaceuticals usa inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

irbesartan 75 mg/1

Manufacturer
Hisun Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 42658-121
Product ID 42658-121_422e87bf-8271-64d5-e063-6294a90a63ce
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206194
Listing Expiration 2026-12-31
Marketing Start 2017-04-15

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 42658121
Hyphenated Format 42658-121

Supplemental Identifiers

RxCUI
200094 200095 200096
UPC
0342658122018 0342658121011 0342658123015
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 ANDA206194 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (42658-121-01)
  • 90 TABLET, FILM COATED in 1 BOTTLE (42658-121-04)
source: ndc

Packages (2)

42658-121-01 30 TABLET, FILM COATED in 1 BOTTLE (42658-121-01) 42658-121-04 90 TABLET, FILM COATED in 1 BOTTLE (42658-121-04)

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": "422e87bf-8271-64d5-e063-6294a90a63ce", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0342658122018", "0342658121011", "0342658123015"], "unii": ["J0E2756Z7N"], "rxcui": ["200094", "200095", "200096"], "spl_set_id": ["61ab1b6e-c849-49ca-a3f0-150774db649d"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Hisun Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (42658-121-01)", "package_ndc": "42658-121-01", "marketing_start_date": "20170415"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (42658-121-04)", "package_ndc": "42658-121-04", "marketing_start_date": "20170415"}], "brand_name": "IRBESARTAN", "product_id": "42658-121_422e87bf-8271-64d5-e063-6294a90a63ce", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "42658-121", "generic_name": "IRBESARTAN", "labeler_name": "Hisun Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IRBESARTAN", "active_ingredients": [{"name": "IRBESARTAN", "strength": "75 mg/1"}], "application_number": "ANDA206194", "marketing_category": "ANDA", "marketing_start_date": "20170415", "listing_expiration_date": "20261231"}