amiodarone hydrochloride

Product NDC: 48433-154
11-digit product format: 484330154
Labeler code: 48433
Product ID: 48433-154_544f49d5-053a-73e8-e063-6394a90ada25
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amiodarone hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Safecor Health LLC
Application: ANDA079029
Marketing category: ANDA
Marketing start: 2026-06-01
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A079029-001	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16
A079029-002	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-01-06
A079029-003	AMIODARONE HYDROCHLORIDE	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2023-01-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079029-001	AB
A079029-002	AB
A079029-003	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 3 · 95 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
2026-09-14 22:38:34	2026-08	A079029-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079029-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-01-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079029-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2023-01-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079029-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079029-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079029-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2023-01-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079029-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079029-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079029-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2023-01-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079029-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079029-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-01-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079029-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2023-01-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079029-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079029-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-01-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079029-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2023-01-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079029-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079029-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-01-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079029-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2023-01-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079029-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079029-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-01-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079029-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2023-01-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079029-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079029-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-01-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079029-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2023-01-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079029-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079029-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-01-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079029-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2023-01-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079029-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079029-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-01-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079029-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2023-01-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079029-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079029-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-01-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079029-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2023-01-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079029-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079029-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-01-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079029-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2023-01-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079029-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079029-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-01-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079029-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2023-01-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079029-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 95 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A079029-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079029-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079029-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079029-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079029-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079029-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079029-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079029-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079029-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079029-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079029-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079029-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079029-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079029-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079029-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079029-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079029-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079029-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079029-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079029-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079029-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079029-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079029-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079029-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079029-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079029-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079029-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079029-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079029-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079029-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079029-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079029-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079029-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079029-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079029-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079029-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079029-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079029-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079029-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079029-001	AB	1	`301d65b070ca…`

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
f49d011f-5ca6-4f75-ba16-2099fe42f5aa	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
amiodarone hydrochloride	AMIODARONE HYDROCHLORIDE	Safecor Health LLC	f49d011f-5ca6-4f75-ba16-2099fe42f5aa	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079029 application number: ANDA079029 ndc (product): 48433-154
Amiodarone hydrochloride	AMIODARONE HYDROCHLORIDE	Zydus Lifesciences Limited	3e8db251-e3c5-4fba-be9a-6044a92f0beb	2024-11-25		Exact identifier application applno (ANDA): 079029 application number: ANDA079029
amiodarone hydrochloride	AMIODARONE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	b41cbcb5-9c5d-4e45-a4f2-952df5f22c00	2023-03-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079029 application number: ANDA079029

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
48433-154-20	48433015420	100 BLISTER PACK in 1 CARTON (48433-154-20) / 1 TABLET in 1 BLISTER PACK (48433-154-01)	100 blister pack	2026-06-01	No	No	Current