AMIODARONE HYDROCHLORIDE

Product NDC: 0404-9772
11-digit product format: 004049772
Labeler code: 0404
Product ID: 0404-9772_17458257-a90d-43d1-891f-56ebf2fe73b8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amiodarone hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Henry Schein, Inc.
Application: ANDA077234
Marketing category: ANDA
Marketing start: 2025-10-29
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 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A077234-001	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP		2008-02-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077234-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077234-001	AMIODARONE HYDROCHLORIDE	50MG/ML	INJECTABLE / INJECTION	AP	2008-02-25	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077234-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077234-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077234-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077234-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077234-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077234-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077234-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077234-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077234-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077234-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077234-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077234-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077234-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077234-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077234-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077234-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077234-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077234-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077234-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077234-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077234-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077234-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077234-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077234-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077234-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077234-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077234-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077234-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077234-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077234-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077234-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077234-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077234-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077234-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077234-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077234-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077234-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077234-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077234-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077234-001	AP	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: AMIODARONE HYDROCHLORIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMIODARONE HYDROCHLORIDE	50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
976728SY6Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1663224	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
0c9ee15a-5741-4aaa-8d80-c7bd2e45822e	Available on FDA.report

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
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
a0ee8fe5-e56a-6ca2-24dc-111ec6d188e4	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0404-9772-03	AMIODARONE HYDROCHLORIDE	3 mL in 1 VIAL	INJECTION, SOLUTION	3		1
0404-9772-03	AMIODARONE HYDROCHLORIDE	1 in 1 BAG	INJECTION, SOLUTION	1		1

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	REMEDYREPACK INC.	e9151c1b-b70c-477b-868a-fffdc5c51830	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077234 application number: ANDA077234
AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	Henry Schein, Inc.	0c9ee15a-5741-4aaa-8d80-c7bd2e45822e	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077234 application number: ANDA077234 ndc (product): 0404-9772
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	51772745-9ea9-42cd-97e6-7266f41ae3ca	2024-04-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077234 application number: ANDA077234
AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	7639dfe4-933c-2916-e053-2a91aa0a3fe7	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077234 application number: ANDA077234
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	66700f8b-3f76-3749-e053-2a91aa0adfdb	2023-04-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077234 application number: ANDA077234

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	0c9ee15a-5741-4aaa-8d80-c7bd2e45822e	1
1663224	3 ML amiodarone hydrochloride 50 MG/ML Injection	SCD	0c9ee15a-5741-4aaa-8d80-c7bd2e45822e	1
1663224	amiodarone HCl 150 MG per 3 ML Injection	SY	0c9ee15a-5741-4aaa-8d80-c7bd2e45822e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0404-9772-03	00404977203	1 VIAL in 1 BAG (0404-9772-03) / 3 mL in 1 VIAL	1 vial	2025-10-29	No	No	Current