Multaq

Product NDC: 53360-4142
Requested package NDC: 53360-4142-6
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	53360-4142	53360-4142-6	UNFINISHED	Active or certified unfinished drug listing		2026-08-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`

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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022425-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022425-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022425-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022425-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022425-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022425-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022425-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022425-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022425-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022425-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022425-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022425-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022425-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022425-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022425-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022425-001	AB	1	`1c564ffb4f44…`

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	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: No
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DRONEDARONE	400 mg/1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53360-4142-0	2020-02-04	C162847	48780-1	9d75b9d0-5d76-f424-e053-dadaa90a57ce	2e4efbe0-82b5-443b-9eac-a9c1e48d5280
53360-4142-0	2020-01-31	C162847	48780-1	9d75b9d0-5d76-f424-e053-dadaa90a57ce	2e4efbe0-82b5-443b-9eac-a9c1e48d5280

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Multaq	DRONEDARONE	Cardinal Health 107, LLC	3bd4006a-8bad-4909-ac6d-b6d84390155c	2026-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022425 application number: NDA022425
Multaq	DRONEDARONE	Sanofi-Aventis U.S. LLC	7fa41601-7fb5-4155-8e50-2ae903f0d2d6	2025-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022425 application number: NDA022425

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JQZ1L091Y2	DRONEDARONE	141626-36-0	DRONEDARONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
53360-4142-6	53360414206	50 BLISTER PACK in 1 BOX (53360-4142-6) / 6 TABLET, FILM COATED in 1 BLISTER PACK	50 blister pack	01-JUL-09	Current