NDC 53360-4142

Multaq

Dronedarone

Multaq is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sanofi Winthrop Industries. The primary component is Dronedarone.

• Product ID: 53360-4142_fecbdf4d-7761-4945-a23c-5edcc2ed0e4d
• NDC: 53360-4142
• 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: Sanofi Winthrop Industries
• Substance Name: DRONEDARONE
• Active Ingredient Strength: 400 mg/1
• Pharm Classes: Antiarrhythmic [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 53360-4142-0

22750 TABLET, FILM COATED in 1 DRUM (53360-4142-0)

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

Drug Details

Active Ingredients

Ingredient	Strength
DRONEDARONE	400 mg/1

OpenFDA Data

• SPL SET ID: 2e4efbe0-82b5-443b-9eac-a9c1e48d5280
• Manufacturer:
  • Sanofi Winthrop Industries
• UNII:
  • JQZ1L091Y2
• PHarm Class EPC:
  • Antiarrhythmic [EPC]
• 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