Amiodarone Hydrochloride

Product NDC: 70518-2792
Requested package NDC: 70518-2792-1
11-digit product format: 705182792
Labeler code: 70518
Product ID: 70518-2792_e5314c67-69c7-d494-e053-2995a90acf00
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AMIODARONE HYDROCHLORIDE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: REMEDYREPACK INC.
Application: ANDA075761
Marketing category: ANDA
Marketing start: 2020-06-19
Marketing end: 0000-00-00
Substance: AMIODARONE HYDROCHLORIDE
Active strength: 50 mg/mL
Pharmacologic classes: Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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
excluded package	package	70518-2792	70518-2792-1	D	Discontinued by firm		2026-08-11

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 · 11 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 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

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
A075761-001	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075761-001	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 · 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	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075761-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	RS	2002-10-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075761-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075761-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075761-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075761-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075761-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075761-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075761-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075761-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075761-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075761-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075761-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075761-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075761-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075761-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075761-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075761-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075761-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075761-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075761-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075761-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075761-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075761-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075761-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075761-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075761-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075761-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075761-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075761-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075761-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075761-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075761-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075761-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075761-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075761-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075761-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075761-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075761-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075761-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075761-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075761-001	AP	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-2792-1	2022-02-02	C162847	48780-1	d6a99b39-aea6-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use AMIODARONE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for AMIODARONE HYDROCHLORIDE INJECTION. AMIODARONE HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1985
70518-2792-1	2022-01-28	C162847	48780-1	d6a99b39-aea6-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use AMIODARONE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for AMIODARONE HYDROCHLORIDE INJECTION. AMIODARONE HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1985

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70518-2792-0	ML - Milliliter	70518-2792	ad936dab-c612-447a-b9a5-d97b33cfc397	1	2023-01-09
70518-2792-1	ML - Milliliter	70518-2792	7926176e-3121-46de-9b1f-6cf52f1fdef7	1	2023-01-09

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Fresenius Kabi USA, LLC	d8d04647-8e25-4127-8ecf-360ce1991c2f	2025-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075761 application number: ANDA075761
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Fresenius Kabi USA, LLC	9772ab48-2ef1-4b9f-9a27-794f3e7e5c7a	2025-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075761 application number: ANDA075761
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	d889c00c-e27e-4e27-e053-2995a90ad4e1	2023-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075761 application number: ANDA075761
AMIODARONE HCI	AMIODARONE HCI	HF Acquisition Co LLC, DBA HealthFirst	993b2557-6774-bb7a-e053-2995a90a0503	2022-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075761 application number: ANDA075761

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2792-1	70518279201	25 VIAL, SINGLE-DOSE in 1 TRAY (70518-2792-1) > 3 mL in 1 VIAL, SINGLE-DOSE (70518-2792-0)	2020-06-19	0000-00-00	No	No	Current