Amiodarone Hydrochloride

Product NDC: 71335-1297
Requested package NDC: 71335-1297-4
11-digit product format: 713351297
Labeler code: 71335
Product ID: 71335-1297_21812176-0b2b-418f-8286-9ad756f59219
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amiodarone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA204742
Marketing category: ANDA
Marketing start: 2016-06-03
Marketing end: 0000-00-00
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 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	71335-1297	71335-1297-4	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 · 12 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…`

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
A204742-001	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2016-06-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204742-001	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 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	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204742-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2016-06-03	`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	A204742-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204742-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204742-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204742-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204742-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204742-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204742-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204742-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204742-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204742-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204742-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204742-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204742-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204742-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204742-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204742-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204742-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204742-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204742-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204742-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204742-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204742-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204742-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204742-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204742-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204742-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204742-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204742-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204742-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204742-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204742-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204742-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204742-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204742-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204742-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204742-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204742-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204742-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204742-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204742-001	AB	1	`e64feba35796…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	REMEDYREPACK INC.	51a88e8e-da02-4b97-9e7e-442fbffd908d	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204742 application number: ANDA204742
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Cardinal Health 107, LLC	0caedb97-56fd-4ec0-bfb2-c7683b8f5f1b	2026-04-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204742 application number: ANDA204742
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Aurobindo Pharma Limited	7ae393d1-7469-432a-9f21-f5ebab1207d1	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204742 application number: ANDA204742
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	American Health Packaging	d912a75a-ddac-4e7b-b5c4-321d4252ec05	2025-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204742 application number: ANDA204742
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	d42293e9-07fa-41b4-a08b-2e388f5b1e13	2024-08-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204742 application number: ANDA204742
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	A-S Medication Solutions	bfd14110-4bf8-4fbe-a888-7b23fea6ffaa	2024-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204742 application number: ANDA204742

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
71335-1297-4	71335129704	90 TABLET in 1 BOTTLE (71335-1297-4)	90 tablet	2019-08-09	0000-00-00	No	No	Current