Amiodarone Hydrochloride

Product NDC: 0615-8258
11-digit product format: 006158258
Labeler code: 0615
Product ID: 0615-8258_faf8768b-1bab-4a7d-87c2-b13ee31b1853
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amiodarone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: NCS HealthCare of KY, LLC dba Vangard Labs
Application: ANDA204742
Marketing category: ANDA
Marketing start: 2016-06-03
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: 2026-12-31
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 · 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Amiodarone Hydrochloride
Listing expiration: 2026-12-31

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
d42293e9-07fa-41b4-a08b-2e388f5b1e13	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
0615-8258-05	Amiodarone Hydrochloride	15 in 1 BLISTER PACK	TABLET	15		4
0615-8258-39	Amiodarone Hydrochloride	30 in 1 BLISTER PACK	TABLET	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0615-8258	AMIODARONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]	4	Current NDC, Legacy NDC, 2 package rows	20240815_d42293e9-07fa-41b4-a08b-2e388f5b1e13.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 · 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 ndc (product): 0615-8258
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
833528	amiodarone HCl 200 MG Oral Tablet	PSN	d42293e9-07fa-41b4-a08b-2e388f5b1e13	4
833528	amiodarone hydrochloride 200 MG Oral Tablet	SCD	d42293e9-07fa-41b4-a08b-2e388f5b1e13	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0615-8258-05	00615825805	15 TABLET in 1 BLISTER PACK (0615-8258-05)	15 tablet	2019-03-05	0000-00-00	No	No	Current
0615-8258-39	00615825839	30 TABLET in 1 BLISTER PACK (0615-8258-39)	30 tablet	2019-03-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amiodarone Hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	2024-08-09	HUMAN PRESCRIPTION DRUG LABEL	4