Amiodarone Hydrochloride

Product NDC: 55648-739
11-digit product format: 556480739
Labeler code: 55648
Product ID: 55648-739_e11649f1-cacd-4246-ba5c-c45407d16c93
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amiodarone Hydrochloride
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Wockhardt Limited
Application: ANDA077610
Marketing category: ANDA
Marketing start: 2008-10-30
Marketing end: 0000-00-00
Substance: AMIODARONE HYDROCHLORIDE
Active strength: 50 mg/mL
Pharmacologic classes: Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
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	Source date
excluded product	product	55648-739		I	Inactivated by FDA	2026-10-05
excluded package	package	55648-739	55648-739-01	I	Inactivated by FDA	2026-10-05
excluded package	package	55648-739	55648-739-02	I	Inactivated by FDA	2026-10-05
excluded package	package	55648-739	55648-739-04	I	Inactivated by FDA	2026-10-05

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 · 84 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 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55648-739-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55648-739-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55648-739-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55648-739-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55648-739-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55648-739-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55648-739-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55648-739-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55648-739-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55648-739-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55648-739-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55648-739-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55648-739-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55648-739-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55648-739-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55648-739-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55648-739-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55648-739-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55648-739-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55648-739-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55648-739-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55648-739-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55648-739-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55648-739-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55648-739-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55648-739-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55648-739-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55648-739-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55648-739-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55648-739-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55648-739-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55648-739-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55648-739-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55648-739-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55648-739-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55648-739-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55648-739-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55648-739-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55648-739-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55648-739-04	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55648-739-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55648-739-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55648-739-04	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55648-739-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55648-739-01	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077610-001	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2008-10-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A077610-001	AP

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077610-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-10-30	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077610-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077610-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077610-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077610-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077610-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077610-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077610-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077610-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077610-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077610-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077610-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077610-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077610-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077610-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077610-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077610-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077610-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077610-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077610-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077610-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077610-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077610-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077610-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077610-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077610-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077610-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077610-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077610-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077610-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077610-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077610-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077610-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077610-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077610-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077610-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077610-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077610-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077610-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077610-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077610-001	AP	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
555d5389-223f-1ce8-3064-82307acfdb0d	Product name	4	20250325
b88d5283-0ee6-f0b3-21f1-5522444ef3df	Product name	3	20210204
555d5389-223f-1ce8-3064-82307acfdb0d	Product name	3	20171213
1f5577c0-bdff-03f7-f803-d1d3f05329c2	Product name	1	20140508
a0ee8fe5-e56a-6ca2-24dc-111ec6d188e4	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55648-739-01	2020-01-31	C162847	48780-1	9d75b9d0-beff-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use amiodarone safely and effectively. See full prescribing information for amiodarone injection. Amiodarone HCl Injection for intravenous use Initial U.S. Approval: 1985
55648-739-02	2020-01-31	C162847	48780-1	9d75b9d0-beff-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use amiodarone safely and effectively. See full prescribing information for amiodarone injection. Amiodarone HCl Injection for intravenous use Initial U.S. Approval: 1985
55648-739-04	2020-01-31	C162847	48780-1	9d75b9d0-beff-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use amiodarone safely and effectively. See full prescribing information for amiodarone injection. Amiodarone HCl Injection for intravenous use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55648-739-01	Amiodarone Hydrochloride	1 in 1 CARTON	INJECTION	1	1
55648-739-01	Amiodarone Hydrochloride	3 mL in 1 VIAL	INJECTION	3	1
55648-739-02	Amiodarone Hydrochloride	10 in 1 CARTON	INJECTION	10	1
55648-739-02	Amiodarone Hydrochloride	3 mL in 1 VIAL	INJECTION	3	1
55648-739-04	Amiodarone Hydrochloride	3 mL in 1 VIAL	INJECTION	3	1
55648-739-04	Amiodarone Hydrochloride	5 in 1 CARTON	INJECTION	5	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMIODARONE HYDROCHLORIDE	ACTIVE INGREDIENT	976728SY6Z	AMIODARONE HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]	1
AMIODARONE	ACTIVE MOIETY	N3RQ532IUT	AMIODARONE HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	AMIODARONE HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	AMIODARONE HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	AMIODARONE HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55648-739	AMIODARONE HYDROCHLORIDE INJECTION [WOCKHARDT LIMITED]	1	Legacy NDC, 6 package rows	20121128_b0eb6c22-7553-4e3f-a06d-20a186ced99a.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
976728SY6Z	AMIODARONE HYDROCHLORIDE	19774-82-4	AMIODARONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1663224	amiodarone HCl 150 MG in 3 ML Injection	PSN	b0eb6c22-7553-4e3f-a06d-20a186ced99a	1
833532	amiodarone HCl 50 MG/ML Injectable Solution	PSN	b0eb6c22-7553-4e3f-a06d-20a186ced99a	1
1663224	3 ML amiodarone hydrochloride 50 MG/ML Injection	SCD	b0eb6c22-7553-4e3f-a06d-20a186ced99a	1
833532	amiodarone hydrochloride 50 MG/ML Injectable Solution	SCD	b0eb6c22-7553-4e3f-a06d-20a186ced99a	1
1663224	amiodarone HCl 150 MG per 3 ML Injection	SY	b0eb6c22-7553-4e3f-a06d-20a186ced99a	1
833532	amiodarone hydrochloride 450 MG per 9 ML Injectable Solution	SY	b0eb6c22-7553-4e3f-a06d-20a186ced99a	1
833532	amiodarone hydrochloride 900 MG per 18 ML Injectable Solution	SY	b0eb6c22-7553-4e3f-a06d-20a186ced99a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
55648-739-01	55648073901	1 in 1 CARTON		Historical
55648-739-02	55648073902	10 in 1 CARTON		Historical
55648-739-04	55648073904	3 mL in 1 VIAL	3 ml	Historical