avapro

Generic: irbesartan

Labeler: sanofi-aventis u.s. llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name avapro
Generic Name irbesartan
Labeler sanofi-aventis u.s. llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

irbesartan 300 mg/1

Manufacturer
Sanofi-Aventis U.S. LLC

Identifiers & Regulatory

Product NDC 0024-5852
Product ID 0024-5852_b36c9035-33ad-4c8f-b47f-030436e0ef4d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020757
Listing Expiration 2027-12-31
Marketing Start 2013-01-01

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 00245852
Hyphenated Format 0024-5852

Supplemental Identifiers

RxCUI
153666 153667 200095 200096
UPC
0300245852304 0300245851307
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 avapro (source: ndc)
Generic Name irbesartan (source: ndc)
Application Number NDA020757 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0024-5852-30)
source: ndc

Packages (1)

0024-5852-30 30 TABLET, FILM COATED in 1 BOTTLE (0024-5852-30)

Ingredients (1)

irbesartan (300 mg/1)

Linked Drug Pages (1)

Avapro ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b36c9035-33ad-4c8f-b47f-030436e0ef4d", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0300245852304", "0300245851307"], "unii": ["J0E2756Z7N"], "rxcui": ["153666", "153667", "200095", "200096"], "spl_set_id": ["7885b2a8-be4e-48ab-8113-4e6ab791eb98"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Sanofi-Aventis U.S. LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0024-5852-30)", "package_ndc": "0024-5852-30", "marketing_start_date": "20130101"}], "brand_name": "Avapro", "product_id": "0024-5852_b36c9035-33ad-4c8f-b47f-030436e0ef4d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "0024-5852", "generic_name": "irbesartan", "labeler_name": "Sanofi-Aventis U.S. LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Avapro", "active_ingredients": [{"name": "IRBESARTAN", "strength": "300 mg/1"}], "application_number": "NDA020757", "marketing_category": "NDA", "marketing_start_date": "20130101", "listing_expiration_date": "20271231"}