Amiodarone Hydrochloride

Product NDC: 0904-7576
11-digit product format: 009047576
Labeler code: 0904
Product ID: 0904-7576_b8bf4aa2-abea-403d-a6d9-395caf5f87f0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amiodarone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA078578
Marketing category: ANDA
Marketing start: 2026-05-12
Substance: AMIODARONE HYDROCHLORIDE
Active strength: 200 mg/1
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: 2027-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078578-001	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06
A078578-002	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-26
A078578-003	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2021-02-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078578-001	AB
A078578-002	AB
A078578-003	AB

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 3 · 112 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	A078578-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078578-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078578-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2021-02-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078578-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078578-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078578-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2021-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078578-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078578-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078578-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2021-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078578-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078578-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078578-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2021-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078578-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078578-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078578-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2021-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078578-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078578-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078578-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2021-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078578-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078578-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078578-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2021-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078578-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078578-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078578-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2021-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078578-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078578-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078578-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2021-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078578-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078578-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078578-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2021-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078578-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078578-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078578-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2021-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078578-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078578-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078578-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2021-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078578-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078578-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078578-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2021-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078578-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-11-06	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 112 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	A078578-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078578-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078578-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078578-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078578-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078578-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078578-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078578-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078578-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078578-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078578-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078578-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078578-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078578-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078578-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078578-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078578-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078578-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078578-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078578-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078578-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078578-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078578-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078578-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078578-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078578-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078578-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078578-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078578-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078578-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078578-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078578-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078578-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078578-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078578-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078578-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078578-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078578-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078578-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078578-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Amiodarone Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMIODARONE HYDROCHLORIDE	200 mg/1

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
833528	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
b8bf4aa2-abea-403d-a6d9-395caf5f87f0	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
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
0904-7576-61	Amiodarone Hydrochloride	1 in 1 BLISTER PACK	TABLET	1		1
0904-7576-61	Amiodarone Hydrochloride	100 in 1 CARTON	TABLET	100		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	Bryant Ranch Prepack	f4532f12-3b7a-42ab-9a6c-36fd2a3f192c	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078578 application number: ANDA078578
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Major Pharmaceuticals	b8bf4aa2-abea-403d-a6d9-395caf5f87f0	2026-05-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078578 application number: ANDA078578 ndc (product): 0904-7576
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	REMEDYREPACK INC.	337c5695-e3f8-41c6-a088-a492d5c60215	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078578 application number: ANDA078578
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	28cd0224-3569-4308-bd40-480bc4230503	2025-12-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078578 application number: ANDA078578
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Advagen Pharma Limited	d911b4cf-eec4-43f8-aa64-cc60cfc901b9	2025-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078578 application number: ANDA078578

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
833528	amiodarone HCl 200 MG Oral Tablet	PSN	b8bf4aa2-abea-403d-a6d9-395caf5f87f0	1
833528	amiodarone hydrochloride 200 MG Oral Tablet	SCD	b8bf4aa2-abea-403d-a6d9-395caf5f87f0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0904-7576-61	00904757661	100 BLISTER PACK in 1 CARTON (0904-7576-61) / 1 TABLET in 1 BLISTER PACK	100 blister pack	2026-05-12	No	No	Current