irbesartan

Generic: irbesartan

Labeler: quality care products, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name irbesartan
Generic Name irbesartan
Labeler quality care products, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

irbesartan 75 mg/1

Manufacturer
Quality Care Products, LLC

Identifiers & Regulatory

Product NDC 83008-085
Product ID 83008-085_e5af9766-e94f-4240-b3ff-2565a89ba702
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202910
Marketing Start 2024-08-28
Marketing End 2027-02-28

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 83008085
Hyphenated Format 83008-085

Supplemental Identifiers

RxCUI
200094 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
  • 75 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (83008-085-30)
source: ndc

Packages (1)

83008-085-30 30 TABLET in 1 BOTTLE (83008-085-30)

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": "e5af9766-e94f-4240-b3ff-2565a89ba702", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["J0E2756Z7N"], "rxcui": ["200094", "200095"], "spl_set_id": ["9b8581c1-d052-4fe2-a9fc-cf7adf0f9061"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Quality Care Products, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (83008-085-30)", "package_ndc": "83008-085-30", "marketing_end_date": "20270228", "marketing_start_date": "20240828"}], "brand_name": "Irbesartan", "product_id": "83008-085_e5af9766-e94f-4240-b3ff-2565a89ba702", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "83008-085", "generic_name": "Irbesartan", "labeler_name": "Quality Care Products, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Irbesartan", "active_ingredients": [{"name": "IRBESARTAN", "strength": "75 mg/1"}], "application_number": "ANDA202910", "marketing_category": "ANDA", "marketing_end_date": "20270228", "marketing_start_date": "20240828"}