irbesartan

Generic: irbesartan

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

Drug Facts

Product Profile

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

irbesartan 75 mg/1

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-041
Product ID 62332-041_e21c14f4-6c8c-4676-b479-dff181ec3fa1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091236
Listing Expiration 2026-12-31
Marketing Start 2016-07-01

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 62332041
Hyphenated Format 62332-041

Supplemental Identifiers

RxCUI
200094 200095 200096
UPC
0362332042302 0362332041305 0362332043309
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 ANDA091236 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (62332-041-30)
  • 100 TABLET in 1 BOTTLE (62332-041-31)
  • 500 TABLET in 1 BOTTLE (62332-041-71)
  • 90 TABLET in 1 BOTTLE (62332-041-90)
  • 1000 TABLET in 1 BOTTLE (62332-041-91)
source: ndc

Packages (5)

62332-041-30 30 TABLET in 1 BOTTLE (62332-041-30) 62332-041-31 100 TABLET in 1 BOTTLE (62332-041-31) 62332-041-71 500 TABLET in 1 BOTTLE (62332-041-71) 62332-041-90 90 TABLET in 1 BOTTLE (62332-041-90) 62332-041-91 1000 TABLET in 1 BOTTLE (62332-041-91)

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": "e21c14f4-6c8c-4676-b479-dff181ec3fa1", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0362332042302", "0362332041305", "0362332043309"], "unii": ["J0E2756Z7N"], "rxcui": ["200094", "200095", "200096"], "spl_set_id": ["83f5d5c8-27c0-4208-a291-0c4aa55a1ff5"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (62332-041-30)", "package_ndc": "62332-041-30", "marketing_start_date": "20160701"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (62332-041-31)", "package_ndc": "62332-041-31", "marketing_start_date": "20160701"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (62332-041-71)", "package_ndc": "62332-041-71", "marketing_start_date": "20160701"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (62332-041-90)", "package_ndc": "62332-041-90", "marketing_start_date": "20160701"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (62332-041-91)", "package_ndc": "62332-041-91", "marketing_start_date": "20160701"}], "brand_name": "IRBESARTAN", "product_id": "62332-041_e21c14f4-6c8c-4676-b479-dff181ec3fa1", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "62332-041", "generic_name": "IRBESARTAN", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IRBESARTAN", "active_ingredients": [{"name": "IRBESARTAN", "strength": "75 mg/1"}], "application_number": "ANDA091236", "marketing_category": "ANDA", "marketing_start_date": "20160701", "listing_expiration_date": "20261231"}