irbesartan

Generic: irbesartan

Labeler: solco healthcare u.s., llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name irbesartan
Generic Name irbesartan
Labeler solco healthcare u.s., llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

irbesartan 300 mg/1

Manufacturer
Solco Healthcare U.S., LLC

Identifiers & Regulatory

Product NDC 43547-376
Product ID 43547-376_9dd3ba36-25b6-45da-906f-316049b9f23b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203071
Listing Expiration 2026-12-31
Marketing Start 2016-06-13

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 43547376
Hyphenated Format 43547-376

Supplemental Identifiers

RxCUI
200094 200095 200096
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 ANDA203071 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (43547-376-03)
  • 90 TABLET in 1 BOTTLE (43547-376-09)
  • 500 TABLET in 1 BOTTLE (43547-376-50)
source: ndc

Packages (3)

43547-376-03 30 TABLET in 1 BOTTLE (43547-376-03) 43547-376-09 90 TABLET in 1 BOTTLE (43547-376-09) 43547-376-50 500 TABLET in 1 BOTTLE (43547-376-50)

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": "9dd3ba36-25b6-45da-906f-316049b9f23b", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["J0E2756Z7N"], "rxcui": ["200094", "200095", "200096"], "spl_set_id": ["6916c617-92d2-44f5-b968-6267517a2ce6"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Solco Healthcare U.S., LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (43547-376-03)", "package_ndc": "43547-376-03", "marketing_start_date": "20160613"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (43547-376-09)", "package_ndc": "43547-376-09", "marketing_start_date": "20160613"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (43547-376-50)", "package_ndc": "43547-376-50", "marketing_start_date": "20160613"}], "brand_name": "Irbesartan", "product_id": "43547-376_9dd3ba36-25b6-45da-906f-316049b9f23b", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "43547-376", "generic_name": "Irbesartan", "labeler_name": "Solco Healthcare U.S., LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Irbesartan", "active_ingredients": [{"name": "IRBESARTAN", "strength": "300 mg/1"}], "application_number": "ANDA203071", "marketing_category": "ANDA", "marketing_start_date": "20160613", "listing_expiration_date": "20261231"}