Home NDC 53360-4142 Multaq
Product NDC 53360-4142
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 · 4 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 53360-4142 UNFINISHED Active or certified unfinished drug listing 2026-08-12 unfinished product product 53360-4142 UNFINISHED Active or certified unfinished drug listing 2026-08-12 unfinished package package 53360-4142 53360-4142-1 UNFINISHED Active or certified unfinished drug listing 2026-08-12 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 2 · 68 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 53360-4142-1 a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 53360-4142-6 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 53360-4142-1 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 53360-4142-6 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 53360-4142-1 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 53360-4142-6 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 53360-4142-1 e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 53360-4142-6 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 53360-4142-1 bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 53360-4142-6 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 53360-4142-1 f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 53360-4142-6 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 53360-4142-1 f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 53360-4142-6 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 53360-4142-1 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 53360-4142-6 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 53360-4142-1 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 53360-4142-6 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 53360-4142-1 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 53360-4142-6 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 53360-4142-1 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 53360-4142-6 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 53360-4142-1 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 53360-4142-6 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 53360-4142-1 d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 53360-4142-6 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 53360-4142-1 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 53360-4142-6 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 unfinished product product 906f6e251498…bf70b80e44f0…2022-04-09 23:13 UTC · source 2022-04-08 unfinished package package 53360-4142-1 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 unfinished product product 6db9cb8d1e19…3449e1ec5b70…2021-12-27 23:28 UTC · source 2021-12-27 unfinished package package 53360-4142-1 6db9cb8d1e19…3449e1ec5b70…
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 No
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DRONEDARONE 400 mg/1
FDA-Initiated Inactive NDC Indexing# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Status 53360-4142-1 53360414201 50 BLISTER PACK in 1 BOX (53360-4142-1) / 6 TABLET, FILM COATED in 1 BLISTER PACK 50 blister pack 01-JUL-09 Current 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