irbesartan

Generic: irbesartan

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

Drug Facts

Product Profile

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

irbesartan 300 mg/1

Manufacturer
ScieGen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50228-162
Product ID 50228-162_ba124fb5-fa8b-be15-e053-2a95a90ab560
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204774
Listing Expiration 2026-12-31
Marketing Start 2015-12-07

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 50228162
Hyphenated Format 50228-162

Supplemental Identifiers

RxCUI
200094 200095 200096
UPC
0350228160308 0350228160056 0350228161305 0350228162302 0350228161107
UNII
J0E2756Z7N
NUI
N0000000070 N0000175561

Packaging Origin

Original Packager
true

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 ANDA204774 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (50228-162-05)
  • 30 TABLET in 1 BOTTLE (50228-162-30)
source: ndc

Packages (2)

50228-162-05 500 TABLET in 1 BOTTLE (50228-162-05) 50228-162-30 30 TABLET in 1 BOTTLE (50228-162-30)

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": "ba124fb5-fa8b-be15-e053-2a95a90ab560", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0350228160308", "0350228160056", "0350228161305", "0350228162302", "0350228161107"], "unii": ["J0E2756Z7N"], "rxcui": ["200094", "200095", "200096"], "spl_set_id": ["ddca7d7c-07fe-4df6-83ae-a9c05048b66e"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["ScieGen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (50228-162-05)", "package_ndc": "50228-162-05", "marketing_start_date": "20151207"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (50228-162-30)", "package_ndc": "50228-162-30", "marketing_start_date": "20151207"}], "brand_name": "Irbesartan", "product_id": "50228-162_ba124fb5-fa8b-be15-e053-2a95a90ab560", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "50228-162", "generic_name": "Irbesartan", "labeler_name": "ScieGen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Irbesartan", "active_ingredients": [{"name": "IRBESARTAN", "strength": "300 mg/1"}], "application_number": "ANDA204774", "marketing_category": "ANDA", "marketing_start_date": "20151207", "listing_expiration_date": "20261231"}