FDA.reportPublic FDA data

Multaq

Product NDC
55154-8104
11-digit product format
551548104
Labeler code
55154
Product ID
55154-8104_913e2175-cc98-4f39-8941-1a46cc80b888
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dronedarone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
NDA022425
Marketing category
NDA
Marketing start
2009-07-01
Substance
DRONEDARONE
Active strength
400 mg/1
Pharmacologic classes
Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Multaq
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DRONEDARONE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJQZ1L091Y2
Rxcui854856, 854859

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ebf2ac4-7e59-43d5-8f9f-dd4f4d40c1b4Product name120250114

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-8104-2Multaq1260 in 1 BOTTLETABLET, FILM COATED126013

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DronedaroneACTIVE INGREDIENTJQZ1L091Y2MULTAQ (DRONEDARONE) TABLET, FILM COATED [CARDINAL HEALTH]3
DronedaroneACTIVE MOIETYJQZ1L091Y2MULTAQ (DRONEDARONE) TABLET, FILM COATED [CARDINAL HEALTH]3
carnauba waxINACTIVE INGREDIENTR12CBM0EIZMULTAQ (DRONEDARONE) TABLET, FILM COATED [CARDINAL HEALTH]3
crospovidoneINACTIVE INGREDIENT68401960MKMULTAQ (DRONEDARONE) TABLET, FILM COATED [CARDINAL HEALTH]3
hypromellosesINACTIVE INGREDIENT3NXW29V3WOMULTAQ (DRONEDARONE) TABLET, FILM COATED [CARDINAL HEALTH]3
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XMULTAQ (DRONEDARONE) TABLET, FILM COATED [CARDINAL HEALTH]3
magnesium stearateINACTIVE INGREDIENT70097M6I30MULTAQ (DRONEDARONE) TABLET, FILM COATED [CARDINAL HEALTH]3
poloxamer 407INACTIVE INGREDIENTTUF2IVW3M2MULTAQ (DRONEDARONE) TABLET, FILM COATED [CARDINAL HEALTH]3
polyethylene glycol 6000INACTIVE INGREDIENT30IQX730WEMULTAQ (DRONEDARONE) TABLET, FILM COATED [CARDINAL HEALTH]3
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4MULTAQ (DRONEDARONE) TABLET, FILM COATED [CARDINAL HEALTH]3
starch, cornINACTIVE INGREDIENTO8232NY3SJMULTAQ (DRONEDARONE) TABLET, FILM COATED [CARDINAL HEALTH]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPMULTAQ (DRONEDARONE) TABLET, FILM COATED [CARDINAL HEALTH]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-8104MULTAQ (DRONEDARONE) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]11Current NDC, Legacy NDC, 1 package rows20241121_3bd4006a-8bad-4909-ac6d-b6d84390155c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854856dronedarone 400 MG Oral TabletPSN3bd4006a-8bad-4909-ac6d-b6d84390155c13
854859MULTAQ 400 MG Oral TabletPSN3bd4006a-8bad-4909-ac6d-b6d84390155c13
854859dronedarone 400 MG Oral Tablet [Multaq]SBD3bd4006a-8bad-4909-ac6d-b6d84390155c13
854856dronedarone 400 MG Oral TabletSCD3bd4006a-8bad-4909-ac6d-b6d84390155c13
854856dronedarone (as dronedarone hydrochloride) 400 MG Oral TabletSY3bd4006a-8bad-4909-ac6d-b6d84390155c13
854859Multaq 400 MG Oral TabletSY3bd4006a-8bad-4909-ac6d-b6d84390155c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55154-8104-2551548104021260 TABLET, FILM COATED in 1 BOTTLE (55154-8104-2) 2009-07-010000-00-00NoNoCurrent