irbesartan

Generic: irbesartan

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name irbesartan
Generic Name irbesartan
Labeler a-s medication solutions
Dosage Form TABLET
Routes
ORAL
Active Ingredients

irbesartan 300 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7622
Product ID 50090-7622_e9f7cb79-bbeb-405c-8010-44f2ac707691
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 500907622
Hyphenated Format 50090-7622

Supplemental Identifiers

RxCUI
200096
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
  • 300 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (50090-7622-0)
source: ndc

Packages (1)

50090-7622-0 90 TABLET in 1 BOTTLE (50090-7622-0)

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": "e9f7cb79-bbeb-405c-8010-44f2ac707691", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["J0E2756Z7N"], "rxcui": ["200096"], "spl_set_id": ["6babdb48-8384-49ce-a759-d380d79a4010"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (50090-7622-0)", "package_ndc": "50090-7622-0", "marketing_start_date": "20250806"}], "brand_name": "Irbesartan", "product_id": "50090-7622_e9f7cb79-bbeb-405c-8010-44f2ac707691", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "50090-7622", "generic_name": "Irbesartan", "labeler_name": "A-S Medication Solutions", "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"}