irbesartan

Generic: irbesartan

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name irbesartan
Generic Name irbesartan
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

irbesartan 150 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-082
Product ID 71205-082_b40bb16b-4019-4002-8d5e-64c5f887f10b
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 71205082
Hyphenated Format 71205-082

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 ANDA203071 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71205-082-30)
  • 60 TABLET in 1 BOTTLE (71205-082-60)
  • 90 TABLET in 1 BOTTLE (71205-082-90)
source: ndc

Packages (3)

71205-082-30 30 TABLET in 1 BOTTLE (71205-082-30) 71205-082-60 60 TABLET in 1 BOTTLE (71205-082-60) 71205-082-90 90 TABLET in 1 BOTTLE (71205-082-90)

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": "b40bb16b-4019-4002-8d5e-64c5f887f10b", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["J0E2756Z7N"], "rxcui": ["200095"], "spl_set_id": ["b587d89b-8ff9-4180-b31a-bbff5d365a1d"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71205-082-30)", "package_ndc": "71205-082-30", "marketing_start_date": "20180801"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71205-082-60)", "package_ndc": "71205-082-60", "marketing_start_date": "20180801"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71205-082-90)", "package_ndc": "71205-082-90", "marketing_start_date": "20180801"}], "brand_name": "Irbesartan", "product_id": "71205-082_b40bb16b-4019-4002-8d5e-64c5f887f10b", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "71205-082", "generic_name": "Irbesartan", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Irbesartan", "active_ingredients": [{"name": "IRBESARTAN", "strength": "150 mg/1"}], "application_number": "ANDA203071", "marketing_category": "ANDA", "marketing_start_date": "20160613", "listing_expiration_date": "20261231"}