Amiodarone Hydrochloride

Product NDC: 55154-3365
Requested package NDC: 55154-3365-0
11-digit product format: 551543365
Labeler code: 55154
Product ID: 55154-3365_7a34d62f-6b9b-44d2-aefa-8af7e388b13d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amiodarone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA075424
Marketing category: ANDA
Marketing start: 2001-03-30
Marketing end: 2027-01-31
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
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075424-001	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30
A075424-002	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A075424-001	AB
A075424-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2001-03-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2001-03-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2001-03-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2001-03-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2001-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A075424-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075424-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075424-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075424-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075424-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075424-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075424-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075424-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075424-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075424-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075424-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075424-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075424-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075424-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075424-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075424-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075424-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075424-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075424-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075424-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075424-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075424-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075424-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075424-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075424-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075424-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075424-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075424-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075424-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075424-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075424-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075424-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075424-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075424-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075424-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075424-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075424-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075424-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075424-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075424-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Amiodarone Hydrochloride

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
7bdc2236-3a1a-4210-a9fb-38f860227aa7	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
55154-3365-0	Amiodarone Hydrochloride	10 in 1 BAG	TABLET	10		9
55154-3365-0	Amiodarone Hydrochloride	1 in 1 BLISTER PACK	TABLET	1		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55154-3365	AMIODARONE HYDROCHLORIDE TABLET [CARDINAL HEALTH 107, LLC]	7	Current NDC, Legacy NDC, 2 package rows	20250406_7bdc2236-3a1a-4210-a9fb-38f860227aa7.zip

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	Bryant Ranch Prepack	f3e631c5-1204-419c-8dbe-fa9b37a77f97	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075424 application number: ANDA075424
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Cardinal Health 107, LLC	7bdc2236-3a1a-4210-a9fb-38f860227aa7	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075424 application number: ANDA075424 ndc (package): 55154-3365-0 ndc (product): 55154-3365 ndc11 (package): 55154336500
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Major Pharmaceuticals	352ed423-fc16-47bb-8e25-98e1c20f9991	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075424 application number: ANDA075424
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	7ccd3733-c3af-4a11-8500-0f99194c1472	2026-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075424 application number: ANDA075424

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	7bdc2236-3a1a-4210-a9fb-38f860227aa7	9
833528	amiodarone hydrochloride 200 MG Oral Tablet	SCD	7bdc2236-3a1a-4210-a9fb-38f860227aa7	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55154-3365-0	55154336500	10 BLISTER PACK in 1 BAG (55154-3365-0) / 1 TABLET in 1 BLISTER PACK	10 blister pack	2020-04-20	2027-01-31	No	No	Current