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 50090-6938
Product ID 50090-6938_2d81e9fd-c78c-42e1-94fe-1c357d72d969
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202910
Listing Expiration 2026-12-31
Marketing Start 2012-09-27

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 500906938
Hyphenated Format 50090-6938

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 ANDA202910 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (50090-6938-0)
source: ndc

Packages (1)

50090-6938-0 90 TABLET in 1 BOTTLE (50090-6938-0)

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": "2d81e9fd-c78c-42e1-94fe-1c357d72d969", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["J0E2756Z7N"], "rxcui": ["200096"], "spl_set_id": ["9644fa38-dd28-4888-9d55-80967c4fc8d7"], "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 (50090-6938-0)", "package_ndc": "50090-6938-0", "marketing_start_date": "20231215"}], "brand_name": "Irbesartan", "product_id": "50090-6938_2d81e9fd-c78c-42e1-94fe-1c357d72d969", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "50090-6938", "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": "ANDA202910", "marketing_category": "ANDA", "marketing_start_date": "20120927", "listing_expiration_date": "20261231"}