FDA.reportPublic FDA data

Multaq

Product NDC
53360-4142
11-digit product format
533604142
Labeler code
53360
Product ID
53360-4142_fecbdf4d-7761-4945-a23c-5edcc2ed0e4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dronedarone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sanofi Winthrop Industries
Application
NDA022425
Marketing category
NDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
DRONEDARONE
Active strength
400 mg/1
Pharmacologic 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
Current FDA listing
Historical FDA.report record

Additional Listing Data#

Finished product
No
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DRONEDARONE400 mg/1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53360-4142-02020-02-04C16284748780-19d75b9d0-5d76-f424-e053-dadaa90a57ce2e4efbe0-82b5-443b-9eac-a9c1e48d5280
53360-4142-02020-01-31C16284748780-19d75b9d0-5d76-f424-e053-dadaa90a57ce2e4efbe0-82b5-443b-9eac-a9c1e48d5280