Amiodarone Hydrochloride

Product NDC: 50090-3496
Requested package NDC: 50090-3496-2
11-digit product format: 500903496
Labeler code: 50090
Product ID: 50090-3496_0824ef26-73e2-4624-b338-b65b15edc01b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amiodarone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA075424
Marketing category: ANDA
Marketing start: 2001-03-30
Marketing end: 0000-00-00
Substance: AMIODARONE HYDROCHLORIDE
Active strength: 200 mg/1
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: 2021-12-31
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	50090-3496	50090-3496-2	I	Inactivated by FDA		2026-08-17

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 · 15 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…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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

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 · 84 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
2026-08-18 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…`
2022-03-09 01:35 UTC	2022-03	A075424-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2001-03-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075424-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2002-12-18	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	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…`
2022-03-09 01:35 UTC	2022-03	A075424-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075424-002	AB	1	`bb7c543d1eb4…`

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
50090-3496-1	2023-01-30	C162847	48780-1	f386c64a-0525-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use AMIODARONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for AMIODARONE HYDROCHLORIDE TABLETS. AMIODARONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985
50090-3496-2	2023-01-30	C162847	48780-1	f386c64a-0525-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use AMIODARONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for AMIODARONE HYDROCHLORIDE TABLETS. AMIODARONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-3496-1	Amiodarone Hydrochloride	30 in 1 BOTTLE	TABLET	30		3
50090-3496-2	Amiodarone Hydrochloride	90 in 1 BOTTLE	TABLET	90		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3496	AMIODARONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]	3	Legacy NDC, 2 package rows	20200121_01935b03-ce4a-4bb9-a7be-954db4d5fec2.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
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	01935b03-ce4a-4bb9-a7be-954db4d5fec2	3
833528	amiodarone hydrochloride 200 MG Oral Tablet	SCD	01935b03-ce4a-4bb9-a7be-954db4d5fec2	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-3496-2	50090349602	90 TABLET in 1 BOTTLE (50090-3496-2)	90 tablet	2018-06-25	0000-00-00	No	No	Current