Home NDC 55154-8104 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022425-001 MULTAQ DRONEDARONE HYDROCHLORIDE EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022425-001 8410167 2029-04-16 U-1387 2013-04-30 N022425-001 8410167 2029-04-16 U-1388 2013-04-30 N022425-001 9107900 2029-04-16 U-1726 2015-08-21 N022425-001 9107900 2029-04-16 U-1728 2015-08-21 N022425-001 8602215 2031-06-30 U-1473 2014-01-08
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL AB RLD, RS 2009-07-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022425-001 MULTAQ EQ 400MG BASE TABLET / ORAL RLD, RS 2009-07-01 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 6 · 205 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022425-001 8410167 2029-04-16 U-1387 2013-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022425-001 8410167 2029-04-16 U-1388 2013-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022425-001 9107900 2029-04-16 U-1728 2015-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022425-001 9107900 2029-04-16 U-1726 2015-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022425-001 8602215 2031-06-30 U-1473 2014-01-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022425-001 8410167 2029-04-16 U-1387 2013-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022425-001 8410167 2029-04-16 U-1388 2013-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022425-001 9107900 2029-04-16 U-1728 2015-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022425-001 9107900 2029-04-16 U-1726 2015-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022425-001 8602215 2031-06-30 U-1473 2014-01-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022425-001 8410167 2029-04-16 U-1387 2013-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022425-001 8410167 2029-04-16 U-1388 2013-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022425-001 9107900 2029-04-16 U-1728 2015-08-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022425-001 9107900 2029-04-16 U-1726 2015-08-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022425-001 8602215 2031-06-30 U-1473 2014-01-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022425-001 8410167 2029-04-16 U-1387 2013-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022425-001 8410167 2029-04-16 U-1388 2013-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022425-001 9107900 2029-04-16 U-1728 2015-08-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022425-001 9107900 2029-04-16 U-1726 2015-08-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022425-001 8602215 2031-06-30 U-1473 2014-01-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022425-001 8410167 2029-04-16 U-1387 2013-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022425-001 8410167 2029-04-16 U-1388 2013-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022425-001 9107900 2029-04-16 U-1728 2015-08-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022425-001 9107900 2029-04-16 U-1726 2015-08-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022425-001 8602215 2031-06-30 U-1473 2014-01-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022425-001 8410167 2029-04-16 U-1387 2013-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022425-001 8410167 2029-04-16 U-1388 2013-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022425-001 9107900 2029-04-16 U-1728 2015-08-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022425-001 9107900 2029-04-16 U-1726 2015-08-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022425-001 8602215 2031-06-30 U-1473 2014-01-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022425-001 8410167 2029-04-16 U-1387 2013-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022425-001 8410167 2029-04-16 U-1388 2013-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022425-001 9107900 2029-04-16 U-1728 2015-08-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022425-001 9107900 2029-04-16 U-1726 2015-08-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022425-001 8602215 2031-06-30 U-1473 2014-01-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022425-001 8410167 2029-04-16 U-1387 2013-04-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022425-001 8410167 2029-04-16 U-1388 2013-04-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022425-001 9107900 2029-04-16 U-1728 2015-08-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022425-001 9107900 2029-04-16 U-1726 2015-08-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022425-001 8602215 2031-06-30 U-1473 2014-01-08 5bbf6a4d5a75…
Additional Listing Data#
Finished product Yes
Brand name base Multaq
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DRONEDARONE 400 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JQZ1L091Y2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 854856 Internal RxNorm lookup 854859 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55154-8104-2 Multaq 1260 in 1 BOTTLE TABLET, FILM COATED 1260 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Dronedarone ACTIVE INGREDIENT JQZ1L091Y2 MULTAQ (DRONEDARONE) TABLET, FILM COATED [CARDINAL HEALTH] 3 Dronedarone ACTIVE MOIETY JQZ1L091Y2 MULTAQ (DRONEDARONE) TABLET, FILM COATED [CARDINAL HEALTH] 3 carnauba wax INACTIVE INGREDIENT R12CBM0EIZ MULTAQ (DRONEDARONE) TABLET, FILM COATED [CARDINAL HEALTH] 3 crospovidone INACTIVE INGREDIENT 68401960MK MULTAQ (DRONEDARONE) TABLET, FILM COATED [CARDINAL HEALTH] 3 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO MULTAQ (DRONEDARONE) TABLET, FILM COATED [CARDINAL HEALTH] 3 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X MULTAQ (DRONEDARONE) TABLET, FILM COATED [CARDINAL HEALTH] 3 magnesium stearate INACTIVE INGREDIENT 70097M6I30 MULTAQ (DRONEDARONE) TABLET, FILM COATED [CARDINAL HEALTH] 3 poloxamer 407 INACTIVE INGREDIENT TUF2IVW3M2 MULTAQ (DRONEDARONE) TABLET, FILM COATED [CARDINAL HEALTH] 3 polyethylene glycol 6000 INACTIVE INGREDIENT 30IQX730WE MULTAQ (DRONEDARONE) TABLET, FILM COATED [CARDINAL HEALTH] 3 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 MULTAQ (DRONEDARONE) TABLET, FILM COATED [CARDINAL HEALTH] 3 starch, corn INACTIVE INGREDIENT O8232NY3SJ MULTAQ (DRONEDARONE) TABLET, FILM COATED [CARDINAL HEALTH] 3 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP MULTAQ (DRONEDARONE) TABLET, FILM COATED [CARDINAL HEALTH] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-8104 MULTAQ (DRONEDARONE) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] 11 Current NDC, Legacy NDC, 1 package rows 20241121_3bd4006a-8bad-4909-ac6d-b6d84390155c.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55154-8104-2 55154810402 1260 TABLET, FILM COATED in 1 BOTTLE (55154-8104-2) 2009-07-01 0000-00-00 No No Current