multaq

Generic: dronedarone

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

Drug Facts

Product Profile

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

dronedarone 400 mg/1

Manufacturer
Sanofi-Aventis U.S. LLC

Identifiers & Regulatory

Product NDC 0024-4142
Product ID 0024-4142_badf58f9-01fe-4900-be06-784029a72151
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022425
Listing Expiration 2026-12-31
Marketing Start 2009-07-01

Pharmacologic Class

Established (EPC)
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00244142
Hyphenated Format 0024-4142

Supplemental Identifiers

RxCUI
854856 854859
UNII
JQZ1L091Y2
NUI
N0000175426

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 multaq (source: ndc)
Generic Name dronedarone (source: ndc)
Application Number NDA022425 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 6 TABLET, FILM COATED in 1 BLISTER PACK (0024-4142-00)
  • 8 BLISTER PACK in 1 BOX (0024-4142-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK (0024-4142-00)
  • 60 TABLET, FILM COATED in 1 BOTTLE (0024-4142-60)
source: ndc

Packages (3)

0024-4142-00 6 TABLET, FILM COATED in 1 BLISTER PACK (0024-4142-00) 0024-4142-06 8 BLISTER PACK in 1 BOX (0024-4142-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK (0024-4142-00) 0024-4142-60 60 TABLET, FILM COATED in 1 BOTTLE (0024-4142-60)

Ingredients (1)

dronedarone (400 mg/1)

Linked Drug Pages (1)

Multaq ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "badf58f9-01fe-4900-be06-784029a72151", "openfda": {"nui": ["N0000175426"], "unii": ["JQZ1L091Y2"], "rxcui": ["854856", "854859"], "spl_set_id": ["7fa41601-7fb5-4155-8e50-2ae903f0d2d6"], "pharm_class_epc": ["Antiarrhythmic [EPC]"], "manufacturer_name": ["Sanofi-Aventis U.S. LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "6 TABLET, FILM COATED in 1 BLISTER PACK (0024-4142-00)", "package_ndc": "0024-4142-00", "marketing_start_date": "20240601"}, {"sample": true, "description": "8 BLISTER PACK in 1 BOX (0024-4142-06)  / 6 TABLET, FILM COATED in 1 BLISTER PACK (0024-4142-00)", "package_ndc": "0024-4142-06", "marketing_start_date": "20090701"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (0024-4142-60)", "package_ndc": "0024-4142-60", "marketing_start_date": "20090701"}], "brand_name": "Multaq", "product_id": "0024-4142_badf58f9-01fe-4900-be06-784029a72151", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antiarrhythmic [EPC]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "0024-4142", "generic_name": "Dronedarone", "labeler_name": "Sanofi-Aventis U.S. LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Multaq", "active_ingredients": [{"name": "DRONEDARONE", "strength": "400 mg/1"}], "application_number": "NDA022425", "marketing_category": "NDA", "marketing_start_date": "20090701", "listing_expiration_date": "20261231"}