irbesartan

Generic: irbesartan

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

Drug Facts

Product Profile

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

irbesartan 300 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-162
Product ID 31722-162_0f3408b4-44be-4a92-a59f-9b5a9716bc9a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204774
Listing Expiration 2026-12-31
Marketing Start 2016-10-06

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 31722162
Hyphenated Format 31722-162

Supplemental Identifiers

RxCUI
200094 200095 200096
UPC
0331722162050 0331722161107
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 (31722-162-05)
source: ndc

Packages (1)

31722-162-05 500 TABLET in 1 BOTTLE (31722-162-05)

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": "0f3408b4-44be-4a92-a59f-9b5a9716bc9a", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0331722162050", "0331722161107"], "unii": ["J0E2756Z7N"], "rxcui": ["200094", "200095", "200096"], "spl_set_id": ["0f3408b4-44be-4a92-a59f-9b5a9716bc9a"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (31722-162-05)", "package_ndc": "31722-162-05", "marketing_start_date": "20161006"}], "brand_name": "Irbesartan", "product_id": "31722-162_0f3408b4-44be-4a92-a59f-9b5a9716bc9a", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "31722-162", "generic_name": "Irbesartan", "labeler_name": "Camber 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": "20161006", "listing_expiration_date": "20261231"}