irbesartan

Generic: irbesartan

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

Drug Facts

Product Profile

Brand Name irbesartan
Generic Name irbesartan
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

irbesartan 150 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8670
Product ID 68788-8670_5e43018e-3cff-4c21-beb4-8f93d20781f0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202910
Listing Expiration 2026-12-31
Marketing Start 2024-05-21

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 687888670
Hyphenated Format 68788-8670

Supplemental Identifiers

RxCUI
200095
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
  • 90 TABLET in 1 BOTTLE (68788-8670-9)
source: ndc

Packages (1)

68788-8670-9 90 TABLET in 1 BOTTLE (68788-8670-9)

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": "5e43018e-3cff-4c21-beb4-8f93d20781f0", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["J0E2756Z7N"], "rxcui": ["200095"], "spl_set_id": ["197871da-e0c5-49a9-8dd0-34a8c2685c6b"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-8670-9)", "package_ndc": "68788-8670-9", "marketing_start_date": "20240521"}], "brand_name": "Irbesartan", "product_id": "68788-8670_5e43018e-3cff-4c21-beb4-8f93d20781f0", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "68788-8670", "generic_name": "Irbesartan", "labeler_name": "Preferred Pharmaceuticals Inc.", "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": "20240521", "listing_expiration_date": "20261231"}