irbesartan

Generic: irbesartan

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

Drug Facts

Product Profile

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

irbesartan 75 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-439
Product ID 46708-439_2efa4733-b806-42ee-b587-cae816493fa7
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 46708439
Hyphenated Format 46708-439

Supplemental Identifiers

RxCUI
200094 200095 200096
UPC
0346708439309 0346708441302 0346708440305
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 (46708-439-30)
  • 100 TABLET in 1 BOTTLE (46708-439-31)
  • 500 TABLET in 1 BOTTLE (46708-439-71)
  • 90 TABLET in 1 BOTTLE (46708-439-90)
  • 1000 TABLET in 1 BOTTLE (46708-439-91)
source: ndc

Packages (5)

46708-439-30 30 TABLET in 1 BOTTLE (46708-439-30) 46708-439-31 100 TABLET in 1 BOTTLE (46708-439-31) 46708-439-71 500 TABLET in 1 BOTTLE (46708-439-71) 46708-439-90 90 TABLET in 1 BOTTLE (46708-439-90) 46708-439-91 1000 TABLET in 1 BOTTLE (46708-439-91)

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": "2efa4733-b806-42ee-b587-cae816493fa7", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0346708439309", "0346708441302", "0346708440305"], "unii": ["J0E2756Z7N"], "rxcui": ["200094", "200095", "200096"], "spl_set_id": ["0898f423-0aa9-409c-8d4e-1349b59141d1"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (46708-439-30)", "package_ndc": "46708-439-30", "marketing_start_date": "20160701"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (46708-439-31)", "package_ndc": "46708-439-31", "marketing_start_date": "20160701"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (46708-439-71)", "package_ndc": "46708-439-71", "marketing_start_date": "20160701"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (46708-439-90)", "package_ndc": "46708-439-90", "marketing_start_date": "20160701"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (46708-439-91)", "package_ndc": "46708-439-91", "marketing_start_date": "20160701"}], "brand_name": "IRBESARTAN", "product_id": "46708-439_2efa4733-b806-42ee-b587-cae816493fa7", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "46708-439", "generic_name": "IRBESARTAN", "labeler_name": "Alembic Pharmaceuticals Limited", "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"}