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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0024-4142	0024-4142-10	D	Discontinued by firm		2026-08-10
excluded package	package	0024-4142	0024-4142-50	D	Discontinued by firm		2026-08-10

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	0024-4142-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0024-4142-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	0024-4142-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0024-4142-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	0024-4142-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0024-4142-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	0024-4142-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0024-4142-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	0024-4142-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0024-4142-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	0024-4142-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0024-4142-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	0024-4142-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0024-4142-50	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	0024-4142-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	0024-4142-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	0024-4142-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	0024-4142-50	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	0024-4142-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	0024-4142-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	0024-4142-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	0024-4142-50	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	0024-4142-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	0024-4142-50	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Yes
Brand name base: Multaq
Listing expiration: 2026-12-31

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7fa41601-7fb5-4155-8e50-2ae903f0d2d6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5ebf2ac4-7e59-43d5-8f9f-dd4f4d40c1b4	Product name	1	20250114

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
0024-4142-06	These 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
0024-4142-10	These 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
0024-4142-50	These 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
0024-4142-60	These 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 NDC	Product	Description	Form	Quantity	SPL version
0024-4142-00	Multaq	6 in 1 BLISTER PACK	TABLET, FILM COATED	6	37
0024-4142-06	Multaq	8 in 1 BOX	TABLET, FILM COATED	8	37
0024-4142-10	Multaq	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	37
0024-4142-10	Multaq	10 in 1 BOX	TABLET, FILM COATED	10	37
0024-4142-50	Multaq	500 in 1 BOTTLE	TABLET, FILM COATED	500	37
0024-4142-60	Multaq	60 in 1 BOTTLE	TABLET, FILM COATED	60	37

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0024-4142-10	EA - Each	0024-4142	7c134bb2-6e52-4a0e-b506-64bb2eaeecb7	1	2012-07-24
0024-4142-18	EA - Each	0024-4142	466da1e2-de71-4365-a2b2-17751642590d	1	2012-07-24
0024-4142-60	EA - Each	0024-4142	52f55635-5110-4c6d-9073-889d51459120	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Dronedarone	ACTIVE INGREDIENT	JQZ1L091Y2	MULTAQ (DRONEDARONE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	22
Dronedarone	ACTIVE MOIETY	JQZ1L091Y2	MULTAQ (DRONEDARONE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	22
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	MULTAQ (DRONEDARONE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	22
crospovidone	INACTIVE INGREDIENT	68401960MK	MULTAQ (DRONEDARONE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	22
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	MULTAQ (DRONEDARONE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	22
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	MULTAQ (DRONEDARONE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	22
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	MULTAQ (DRONEDARONE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	22
poloxamer 407	INACTIVE INGREDIENT	TUF2IVW3M2	MULTAQ (DRONEDARONE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	22
polyethylene glycol 6000	INACTIVE INGREDIENT	30IQX730WE	MULTAQ (DRONEDARONE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	22
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	MULTAQ (DRONEDARONE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	22
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	MULTAQ (DRONEDARONE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	22
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	MULTAQ (DRONEDARONE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	22
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
Dronedarone	ACTIVE INGREDIENT	JQZ1L091Y2	MULTAQ (DRONEDARONE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
Dronedarone	ACTIVE MOIETY	JQZ1L091Y2	MULTAQ (DRONEDARONE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0024-4142	MULTAQ (DRONEDARONE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]	36	Current NDC, Legacy NDC, 6 package rows	20240602_7fa41601-7fb5-4155-8e50-2ae903f0d2d6.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.

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 ndc (product): 0024-4142

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
854856	dronedarone 400 MG Oral Tablet	PSN	7fa41601-7fb5-4155-8e50-2ae903f0d2d6	37
854859	MULTAQ 400 MG Oral Tablet	PSN	7fa41601-7fb5-4155-8e50-2ae903f0d2d6	37
854859	dronedarone 400 MG Oral Tablet [Multaq]	SBD	7fa41601-7fb5-4155-8e50-2ae903f0d2d6	37
854856	dronedarone 400 MG Oral Tablet	SCD	7fa41601-7fb5-4155-8e50-2ae903f0d2d6	37
854856	dronedarone (as dronedarone hydrochloride) 400 MG Oral Tablet	SY	7fa41601-7fb5-4155-8e50-2ae903f0d2d6	37
854859	Multaq 400 MG Oral Tablet	SY	7fa41601-7fb5-4155-8e50-2ae903f0d2d6	37
854856	dronedarone 400 MG Oral Tablet	PSN	3bd4006a-8bad-4909-ac6d-b6d84390155c	13
854859	MULTAQ 400 MG Oral Tablet	PSN	3bd4006a-8bad-4909-ac6d-b6d84390155c	13
854859	dronedarone 400 MG Oral Tablet [Multaq]	SBD	3bd4006a-8bad-4909-ac6d-b6d84390155c	13
854856	dronedarone 400 MG Oral Tablet	SCD	3bd4006a-8bad-4909-ac6d-b6d84390155c	13
854856	dronedarone (as dronedarone hydrochloride) 400 MG Oral Tablet	SY	3bd4006a-8bad-4909-ac6d-b6d84390155c	13
854859	Multaq 400 MG Oral Tablet	SY	3bd4006a-8bad-4909-ac6d-b6d84390155c	13
854856	dronedarone 400 MG Oral Tablet	PSN	236d4549-f44b-4677-b857-acedd10b9920	2
854859	MULTAQ 400 MG Oral Tablet	PSN	236d4549-f44b-4677-b857-acedd10b9920	2
854859	dronedarone 400 MG Oral Tablet [Multaq]	SBD	236d4549-f44b-4677-b857-acedd10b9920	2
854856	dronedarone 400 MG Oral Tablet	SCD	236d4549-f44b-4677-b857-acedd10b9920	2
854856	dronedarone (as dronedarone hydrochloride) 400 MG Oral Tablet	SY	236d4549-f44b-4677-b857-acedd10b9920	2
854859	Multaq 400 MG Oral Tablet	SY	236d4549-f44b-4677-b857-acedd10b9920	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0024-4142-00	00024414200	6 TABLET, FILM COATED in 1 BLISTER PACK (0024-4142-00)		2024-06-01		Yes	No	Current
0024-4142-06	00024414206	8 BLISTER PACK in 1 BOX (0024-4142-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK (0024-4142-00)	8 blister pack	2009-07-01	0000-00-00	Yes	No	Current
0024-4142-10	00024414210	10 BLISTER PACK in 1 BOX (0024-4142-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2009-07-01	2021-09-30	No	No	Current
0024-4142-50	00024414250	500 in 1 BOTTLE						Historical
0024-4142-60	00024414260	60 TABLET, FILM COATED in 1 BOTTLE (0024-4142-60)		2009-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Multaq	Cardinal Health 107, LLC	2026-01-27	HUMAN PRESCRIPTION DRUG LABEL	13
Multaq	Sanofi-Aventis U.S. LLC \| Sanofi Winthrop Industrie \| Genzyme Corporation	2025-05-29	HUMAN PRESCRIPTION DRUG LABEL	37
Multaq	Physicians Total Care, Inc.	2011-12-28	HUMAN PRESCRIPTION DRUG LABEL	2