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 ID: 55154-8104_4a0c1e4c-981d-4f0b-afe9-8d97b90c5220
• NDC: 55154-8104
• Product Type: Human Prescription Drug
• Proprietary Name: Multaq
• Generic Name: Dronedarone
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2009-07-01
• Marketing Category: NDA / NDA
• Application Number: NDA022425
• Labeler Name: Cardinal Health 107, LLC
• Substance Name: DRONEDARONE
• Active Ingredient Strength: 400 mg/1
• Pharm Classes: Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2024-12-31

Packaging

NDC 55154-8104-2

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

• Marketing Start Date: 2009-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55154-8104-2 [55154810402]

Multaq TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022425
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-07-01

NDC 55154-8104-8 [55154810408]

Multaq TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022425
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-07-01
• Marketing End Date: 2017-12-31

Drug Details

Active Ingredients

Ingredient	Strength
DRONEDARONE	400 mg/1

OpenFDA Data

• SPL SET ID: 3bd4006a-8bad-4909-ac6d-b6d84390155c
• Manufacturer:
  • Cardinal Health
• UNII:
  • JQZ1L091Y2
• 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"

NDC	Brand Name	Generic Name
0024-4142	Multaq	Dronedarone
53360-4142	Multaq	dronedarone
55154-8104	Multaq	Dronedarone