FDA.reportPublic FDA data

Multaq

Product NDC
0024-4142
11-digit product format
000244142
Labeler code
0024
Product ID
0024-4142_badf58f9-01fe-4900-be06-784029a72151
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dronedarone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sanofi-Aventis U.S. 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Multaq
Listing expiration
2026-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0024-4142-062024-01-30C16284748780-11030e365-1b63-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MULTAQ safely and effectively. See full prescribing information for MULTAQ. MULTAQ® (dronedarone) tablets, for oral use Initial U.S. Approval: 2009
0024-4142-102024-01-30C16284748780-11030e365-1b63-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MULTAQ safely and effectively. See full prescribing information for MULTAQ. MULTAQ® (dronedarone) tablets, for oral use Initial U.S. Approval: 2009
0024-4142-502024-01-30C16284748780-11030e365-1b63-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MULTAQ safely and effectively. See full prescribing information for MULTAQ. MULTAQ® (dronedarone) tablets, for oral use Initial U.S. Approval: 2009
0024-4142-602024-01-30C16284748780-11030e365-1b63-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MULTAQ safely and effectively. See full prescribing information for MULTAQ. MULTAQ® (dronedarone) tablets, for oral use Initial U.S. Approval: 2009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0024-4142-00Multaq6 in 1 BLISTER PACKTABLET, FILM COATED637
0024-4142-06Multaq8 in 1 BOXTABLET, FILM COATED837
0024-4142-10Multaq10 in 1 BLISTER PACKTABLET, FILM COATED1037
0024-4142-10Multaq10 in 1 BOXTABLET, FILM COATED1037
0024-4142-50Multaq500 in 1 BOTTLETABLET, FILM COATED50037
0024-4142-60Multaq60 in 1 BOTTLETABLET, FILM COATED6037

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0024-4142-10EA - Each0024-41427c134bb2-6e52-4a0e-b506-64bb2eaeecb712012-07-24
0024-4142-18EA - Each0024-4142466da1e2-de71-4365-a2b2-17751642590d12012-07-24
0024-4142-60EA - Each0024-414252f55635-5110-4c6d-9073-889d5145912012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DronedaroneACTIVE INGREDIENTJQZ1L091Y2MULTAQ (DRONEDARONE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]22
DronedaroneACTIVE MOIETYJQZ1L091Y2MULTAQ (DRONEDARONE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]22
carnauba waxINACTIVE INGREDIENTR12CBM0EIZMULTAQ (DRONEDARONE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]22
crospovidoneINACTIVE INGREDIENT68401960MKMULTAQ (DRONEDARONE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]22
hypromellosesINACTIVE INGREDIENT3NXW29V3WOMULTAQ (DRONEDARONE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]22
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XMULTAQ (DRONEDARONE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]22
magnesium stearateINACTIVE INGREDIENT70097M6I30MULTAQ (DRONEDARONE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]22
poloxamer 407INACTIVE INGREDIENTTUF2IVW3M2MULTAQ (DRONEDARONE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]22
polyethylene glycol 6000INACTIVE INGREDIENT30IQX730WEMULTAQ (DRONEDARONE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]22
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4MULTAQ (DRONEDARONE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]22
starch, cornINACTIVE INGREDIENTO8232NY3SJMULTAQ (DRONEDARONE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]22
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPMULTAQ (DRONEDARONE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]22
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
DronedaroneACTIVE INGREDIENTJQZ1L091Y2MULTAQ (DRONEDARONE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
DronedaroneACTIVE MOIETYJQZ1L091Y2MULTAQ (DRONEDARONE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0024-4142MULTAQ (DRONEDARONE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]36Current NDC, Legacy NDC, 6 package rows20240602_7fa41601-7fb5-4155-8e50-2ae903f0d2d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854856dronedarone 400 MG Oral TabletPSN7fa41601-7fb5-4155-8e50-2ae903f0d2d637
854859MULTAQ 400 MG Oral TabletPSN7fa41601-7fb5-4155-8e50-2ae903f0d2d637
854859dronedarone 400 MG Oral Tablet [Multaq]SBD7fa41601-7fb5-4155-8e50-2ae903f0d2d637
854856dronedarone 400 MG Oral TabletSCD7fa41601-7fb5-4155-8e50-2ae903f0d2d637
854856dronedarone (as dronedarone hydrochloride) 400 MG Oral TabletSY7fa41601-7fb5-4155-8e50-2ae903f0d2d637
854859Multaq 400 MG Oral TabletSY7fa41601-7fb5-4155-8e50-2ae903f0d2d637
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
854856dronedarone 400 MG Oral TabletPSN236d4549-f44b-4677-b857-acedd10b99202
854859MULTAQ 400 MG Oral TabletPSN236d4549-f44b-4677-b857-acedd10b99202
854859dronedarone 400 MG Oral Tablet [Multaq]SBD236d4549-f44b-4677-b857-acedd10b99202
854856dronedarone 400 MG Oral TabletSCD236d4549-f44b-4677-b857-acedd10b99202
854856dronedarone (as dronedarone hydrochloride) 400 MG Oral TabletSY236d4549-f44b-4677-b857-acedd10b99202
854859Multaq 400 MG Oral TabletSY236d4549-f44b-4677-b857-acedd10b99202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0024-4142-00000244142006 TABLET, FILM COATED in 1 BLISTER PACK (0024-4142-00) 2024-06-01YesNoCurrent
0024-4142-06000244142068 BLISTER PACK in 1 BOX (0024-4142-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK (0024-4142-00) 8 blister pack2009-07-010000-00-00YesNoCurrent
0024-4142-100002441421010 BLISTER PACK in 1 BOX (0024-4142-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2009-07-012021-09-30NoNoCurrent
0024-4142-5000024414250500 in 1 BOTTLEHistorical
0024-4142-600002441426060 TABLET, FILM COATED in 1 BOTTLE (0024-4142-60) 2009-07-010000-00-00NoNoCurrent