Amiodarone Hydrochloride

Product NDC: 50090-5062
Requested package NDC: 50090-5062-2
11-digit product format: 500905062
Labeler code: 50090
Product ID: 50090-5062_2aaef59b-6113-4764-8120-0ec936a7a5f5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amiodarone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA075389
Marketing category: ANDA
Marketing start: 2018-08-01
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: 2022-12-31
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	50090-5062	50090-5062-2	D	Discontinued by firm		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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-5062	50090-5062-2	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-5062	50090-5062-2	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A075389-001	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2001-01-25
A075389-002	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-12-28
A075389-003	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2017-12-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075389-001	AB
A075389-002	AB
A075389-003	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 4 · 126 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	A075389-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2001-01-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075389-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-12-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075389-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2017-12-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075389-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2001-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075389-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075389-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2017-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075389-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2001-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075389-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075389-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2017-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075389-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2001-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075389-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075389-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2017-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075389-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2001-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075389-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075389-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2017-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075389-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2001-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075389-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075389-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2017-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075389-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2001-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075389-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075389-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2017-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075389-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2001-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075389-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075389-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2017-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075389-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2001-01-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075389-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075389-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2017-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075389-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2001-01-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075389-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075389-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2017-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075389-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2001-01-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075389-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075389-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2017-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075389-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2001-01-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075389-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075389-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2017-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075389-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2001-01-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075389-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075389-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2017-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075389-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2001-01-25	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A075389-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075389-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075389-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075389-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075389-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075389-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075389-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075389-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075389-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075389-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075389-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075389-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075389-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075389-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075389-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075389-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075389-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075389-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075389-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075389-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075389-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075389-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075389-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075389-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075389-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075389-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075389-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075389-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075389-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075389-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075389-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075389-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075389-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075389-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075389-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075389-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075389-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075389-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075389-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075389-001	AB	1	`1e350fbaab3a…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-5062-1	2023-02-07	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
50090-5062-2	2023-02-07	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
50090-5062-1	2023-01-30	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
50090-5062-2	2023-01-30	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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5062	AMIODARONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]	5	Legacy NDC	20230208_fd556b8d-4b71-4d33-968a-399b8ec8e6ce.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Dr. Reddy's Labratories Inc.	95cef33b-c0e6-b17c-7cbb-f5c066872705	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075389 application number: ANDA075389
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	AvPAK	924c9359-ebc4-62a7-e053-2a95a90a4327	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075389 application number: ANDA075389

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5062-2	50090506202	90 TABLET in 1 BOTTLE (50090-5062-2)	90 tablet	2020-05-27	0000-00-00	No	No	Current