Amiodarone Hydrochloride

Product NDC: 71335-1942
Requested package NDC: 71335-1942-1
11-digit product format: 713351942
Labeler code: 71335
Product ID: 71335-1942_5b27ec4d-eebc-445d-a4ab-fced073afaa6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amiodarone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
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: 2026-12-31
Current FDA listing: Yes

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 · 1 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
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71335-1942	71335-1942-1	D	Discontinued by firm		excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
2026-02-19 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
2026-02-19 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…`

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
8377eb89-0d62-48c5-90e7-e96d545a4642	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	SPL version
71335-1942-1	Amiodarone Hydrochloride	200 in 1 BOTTLE	TABLET	200	104
71335-1942-2	Amiodarone Hydrochloride	30 in 1 BOTTLE	TABLET	30	104
71335-1942-3	Amiodarone Hydrochloride	60 in 1 BOTTLE	TABLET	60	104
71335-1942-4	Amiodarone Hydrochloride	90 in 1 BOTTLE	TABLET	90	104
71335-1942-5	Amiodarone Hydrochloride	10 in 1 BOTTLE	TABLET	10	104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-1942-2	EA - Each	71335-1942	a4a454df-81cd-4e5f-b5d0-6486bb599aa9	1	2025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1942	AMIODARONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	103	Current NDC, Legacy NDC, 5 package rows	20241004_8377eb89-0d62-48c5-90e7-e96d545a4642.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 · 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
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 ndc (package): 71335-1942-1 ndc (product): 71335-1942 ndc11 (package): 71335194201
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
833528	amiodarone HCl 200 MG Oral Tablet	PSN	8377eb89-0d62-48c5-90e7-e96d545a4642	104
833528	amiodarone hydrochloride 200 MG Oral Tablet	SCD	8377eb89-0d62-48c5-90e7-e96d545a4642	104

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1942-1	71335194201	200 TABLET in 1 BOTTLE (71335-1942-1)	200 tablet	2021-09-03	0000-00-00	No	No	Current