multaq

Generic: dronedarone

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name multaq
Generic Name dronedarone
Labeler cardinal health 107, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

dronedarone 400 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-8104
Product ID 55154-8104_913e2175-cc98-4f39-8941-1a46cc80b888
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022425
Listing Expiration 2027-12-31
Marketing Start 2009-07-01

Pharmacologic Class

Established (EPC)
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 551548104
Hyphenated Format 55154-8104

Supplemental Identifiers

RxCUI
854856 854859
UNII
JQZ1L091Y2
NUI
N0000175426

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
  • 1260 TABLET, FILM COATED in 1 BOTTLE (55154-8104-2)
source: ndc

Packages (1)

55154-8104-2 1260 TABLET, FILM COATED in 1 BOTTLE (55154-8104-2)

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": "913e2175-cc98-4f39-8941-1a46cc80b888", "openfda": {"nui": ["N0000175426"], "unii": ["JQZ1L091Y2"], "rxcui": ["854856", "854859"], "spl_set_id": ["3bd4006a-8bad-4909-ac6d-b6d84390155c"], "pharm_class_epc": ["Antiarrhythmic [EPC]"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1260 TABLET, FILM COATED in 1 BOTTLE (55154-8104-2)", "package_ndc": "55154-8104-2", "marketing_start_date": "20090701"}], "brand_name": "Multaq", "product_id": "55154-8104_913e2175-cc98-4f39-8941-1a46cc80b888", "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": "55154-8104", "generic_name": "Dronedarone", "labeler_name": "Cardinal Health 107, 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": "20271231"}