irbesartan

Generic: irbesartan

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

Drug Facts

Product Profile

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

irbesartan 150 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-411
Product ID 68180-411_22c8bdba-6c34-485a-af89-3aafd7fd8605
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201531
Listing Expiration 2026-12-31
Marketing Start 2012-10-23

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 68180411
Hyphenated Format 68180-411

Supplemental Identifiers

RxCUI
200094 200095 200096
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 ANDA201531 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING Irbesartan Tablets USP are available as white to off-white, oval shaped, uncoated tablets, debossed with a LU on one side and a code on the other (see Table below). Unit-of-use bottles contain 30 or 90 or 500 tablets as follows: 75 mg 150 mg 300 mg Debossing M11 M12 M13 Bottle of 30 68180-410-06 68180-411-06 68180-412-06 Bottle of 90 68180-410-09 68180-411-09 68180-412-09 Bottle of 500 - 68180-411-02 68180-412-02 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Irbesartan Tablets Rx Only 75 mg NDC 68180-410-06 30's Tablets Irbesartan Tablets Rx Only 150 mg NDC 68180-411-06 30's Tablets Irbesartan Tablets Rx Only 300 mg NDC 68180-412-06 30's Tablets image 4 Image 5 Image 6
source: label

Packages (0)

No package records.

Ingredients (1)

irbesartan (150 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": "22c8bdba-6c34-485a-af89-3aafd7fd8605", "openfda": {"nui": ["N0000000070", "N0000175561"], "unii": ["J0E2756Z7N"], "rxcui": ["200094", "200095", "200096"], "spl_set_id": ["a7c093c2-3eef-4956-8a14-c36aada0304f"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Irbesartan", "product_id": "68180-411_22c8bdba-6c34-485a-af89-3aafd7fd8605", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "68180-411", "generic_name": "Irbesartan", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Irbesartan", "active_ingredients": [{"name": "IRBESARTAN", "strength": "150 mg/1"}], "application_number": "ANDA201531", "marketing_category": "ANDA", "marketing_start_date": "20121023", "listing_expiration_date": "20261231"}