Amiodarone Hydrochloride

Product NDC: 67296-2296
11-digit product format: 672962296
Labeler code: 67296
Product ID: 67296-2296_57f7f2ec-3e5b-4ccf-e063-6294a90a5cf1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amiodarone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Redpharm Drug
Application: ANDA213446
Marketing category: ANDA
Marketing start: 2020-09-01
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: 2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213446-001	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2020-07-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213446-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213446-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2020-07-21	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A213446-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213446-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213446-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213446-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213446-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213446-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213446-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213446-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213446-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213446-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213446-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213446-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213446-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213446-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213446-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213446-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213446-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213446-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213446-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213446-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213446-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213446-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213446-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213446-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213446-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213446-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213446-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213446-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213446-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213446-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213446-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213446-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213446-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213446-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213446-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213446-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213446-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213446-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213446-001	AB	1	`a50c72e98297…`

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
Listing expiration: 2027-12-31

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
57f7f2ea-4ca9-4ada-e063-6294a90a492b	Available on FDA.report

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	REMEDYREPACK INC.	4c149392-a4f0-4e2d-a13f-2b94810005de	2026-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213446 application number: ANDA213446
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Redpharm Drug	57f7f2ea-4ca9-4ada-e063-6294a90a492b	2026-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213446 application number: ANDA213446 ndc (product): 67296-2296
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Bryant Ranch Prepack	8377eb89-0d62-48c5-90e7-e96d545a4642	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213446 application number: ANDA213446
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	A-S Medication Solutions	c536e0ad-2758-4022-8242-f5e9b6aca1e2	2023-08-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213446 application number: ANDA213446
Amiodarone Hydrochloride	AMIODARONE HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	a20d0c03-cfda-49d1-88c9-be1bf295bc6c	2023-02-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213446 application number: ANDA213446

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	Sample	Exclude flag	Status
67296-2296-3	67296229603	30 TABLET in 1 BOTTLE (67296-2296-3)	30 tablet	2020-09-01	No	No	Current