irbesartan

Generic: irbesartan

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

Drug Facts

Product Profile

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

irbesartan 300 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-049
Product ID 33342-049_6838a6ad-aea4-4f3b-a3f8-466c76b41e75
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202254
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 33342049
Hyphenated Format 33342-049

Supplemental Identifiers

RxCUI
200094 200095 200096
UPC
0333342049100 0333342047106 0333342048103
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 ANDA202254 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (33342-049-07)
  • 90 TABLET in 1 BOTTLE (33342-049-10)
  • 500 TABLET in 1 BOTTLE (33342-049-15)
  • 9 BLISTER PACK in 1 CARTON (33342-049-39) / 10 TABLET in 1 BLISTER PACK
  • 3400 TABLET in 1 POUCH (33342-049-76)
source: ndc

Packages (5)

33342-049-07 30 TABLET in 1 BOTTLE (33342-049-07) 33342-049-10 90 TABLET in 1 BOTTLE (33342-049-10) 33342-049-15 500 TABLET in 1 BOTTLE (33342-049-15) 33342-049-39 9 BLISTER PACK in 1 CARTON (33342-049-39) / 10 TABLET in 1 BLISTER PACK 33342-049-76 3400 TABLET in 1 POUCH (33342-049-76)

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": "6838a6ad-aea4-4f3b-a3f8-466c76b41e75", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0333342049100", "0333342047106", "0333342048103"], "unii": ["J0E2756Z7N"], "rxcui": ["200094", "200095", "200096"], "spl_set_id": ["e8635a1c-ae06-4e23-99f7-e704f91d6f43"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (33342-049-07)", "package_ndc": "33342-049-07", "marketing_start_date": "20120927"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (33342-049-10)", "package_ndc": "33342-049-10", "marketing_start_date": "20130311"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (33342-049-15)", "package_ndc": "33342-049-15", "marketing_start_date": "20120927"}, {"sample": false, "description": "9 BLISTER PACK in 1 CARTON (33342-049-39)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "33342-049-39", "marketing_start_date": "20120927"}, {"sample": false, "description": "3400 TABLET in 1 POUCH (33342-049-76)", "package_ndc": "33342-049-76", "marketing_start_date": "20190226"}], "brand_name": "Irbesartan", "product_id": "33342-049_6838a6ad-aea4-4f3b-a3f8-466c76b41e75", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "33342-049", "generic_name": "Irbesartan", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Irbesartan", "active_ingredients": [{"name": "IRBESARTAN", "strength": "300 mg/1"}], "application_number": "ANDA202254", "marketing_category": "ANDA", "marketing_start_date": "20120927", "listing_expiration_date": "20261231"}