NDC 55154-8104

Multaq

Dronedarone

Multaq is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Cardinal Health 107, Llc. The primary component is Dronedarone.

Product ID55154-8104_4a0c1e4c-981d-4f0b-afe9-8d97b90c5220
NDC55154-8104
Product TypeHuman Prescription Drug
Proprietary NameMultaq
Generic NameDronedarone
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2009-07-01
Marketing CategoryNDA / NDA
Application NumberNDA022425
Labeler NameCardinal Health 107, LLC
Substance NameDRONEDARONE
Active Ingredient Strength400 mg/1
Pharm ClassesAntiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2024-12-31

Packaging

NDC 55154-8104-2

1260 TABLET, FILM COATED in 1 BOTTLE (55154-8104-2)
Marketing Start Date2009-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55154-8104-2 [55154810402]

Multaq TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022425
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-07-01

NDC 55154-8104-8 [55154810408]

Multaq TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022425
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-07-01
Marketing End Date2017-12-31

Drug Details

Active Ingredients

IngredientStrength
DRONEDARONE400 mg/1

OpenFDA Data

SPL SET ID:3bd4006a-8bad-4909-ac6d-b6d84390155c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 854856
  • 854859
  • PHarm Class EPC
  • Antiarrhythmic [EPC]
  • UPC Code
  • 0355154810426
  • 0355154810488
  • NUI Code
  • N0000175426
  • Pharmacological Class

    • Antiarrhythmic [EPC]
    • Cytochrome P450 3A Inhibitors [MoA]
    • Cytochrome P450 2D6 Inhibitors [MoA]
    • P-Glycoprotein Inhibitors [MoA]

    NDC Crossover Matching brand name "Multaq" or generic name "Dronedarone"

    NDCBrand NameGeneric Name
    0024-4142MultaqDronedarone
    53360-4142Multaqdronedarone
    55154-8104MultaqDronedarone

    Trademark Results [Multaq]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MULTAQ
    MULTAQ
    78692788 3214919 Live/Registered
    SANOFI
    2005-08-15
    MULTAQ
    MULTAQ
    78688826 3214903 Live/Registered
    SANOFI
    2005-08-09
    MULTAQ
    MULTAQ
    78513802 not registered Dead/Abandoned
    Aventis Pharma S.A.
    2004-11-09
    MULTAQ
    MULTAQ
    78139449 2794635 Dead/Cancelled
    SANOFI
    2002-06-27
    MULTAQ
    MULTAQ
    75427934 2230622 Dead/Cancelled
    RHONE-POULENC RORER S.A.
    1998-02-03

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