avalide

Generic: irbesartan and hydrochlorothiazide

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

Drug Facts

Product Profile

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

hydrochlorothiazide 12.5 mg/1, irbesartan 300 mg/1

Manufacturer
Sanofi-Aventis U.S. LLC

Identifiers & Regulatory

Product NDC 0024-5856
Product ID 0024-5856_5f9089ce-2d9c-4077-8774-acd86b5eff4d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020758
Listing Expiration 2026-12-31
Marketing Start 2013-01-01

Pharmacologic Class

Established (EPC)
thiazide diuretic [epc] angiotensin 2 receptor blocker [epc]
Mechanism of Action
angiotensin 2 receptor antagonists [moa]
Chemical Structure
thiazides [cs]
Physiologic Effect
increased diuresis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00245856
Hyphenated Format 0024-5856

Supplemental Identifiers

RxCUI
310792 310793 823934 823938
UPC
0300245856302 0300245855305
UNII
0J48LPH2TH J0E2756Z7N
NUI
N0000175359 N0000175419 M0471776 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 avalide (source: ndc)
Generic Name irbesartan and hydrochlorothiazide (source: ndc)
Application Number NDA020758 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0024-5856-30)
source: ndc

Packages (1)

0024-5856-30 30 TABLET, FILM COATED in 1 BOTTLE (0024-5856-30)

Ingredients (2)

hydrochlorothiazide (12.5 mg/1) irbesartan (300 mg/1)

Linked Drug Pages (1)

Avalide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5f9089ce-2d9c-4077-8774-acd86b5eff4d", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "upc": ["0300245856302", "0300245855305"], "unii": ["0J48LPH2TH", "J0E2756Z7N"], "rxcui": ["310792", "310793", "823934", "823938"], "spl_set_id": ["0d91895e-c869-4b33-9b83-d55c1ad6317e"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [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 (0024-5856-30)", "package_ndc": "0024-5856-30", "marketing_start_date": "20130101"}], "brand_name": "Avalide", "product_id": "0024-5856_5f9089ce-2d9c-4077-8774-acd86b5eff4d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "0024-5856", "generic_name": "irbesartan and hydrochlorothiazide", "labeler_name": "Sanofi-Aventis U.S. LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Avalide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "IRBESARTAN", "strength": "300 mg/1"}], "application_number": "NDA020758", "marketing_category": "NDA", "marketing_start_date": "20130101", "listing_expiration_date": "20261231"}