AMIODARONE HYDROCHLORIDE TABLETS

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-11-25
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 10
Source: full-release
Hydrated at: 2026-05-31 21:18:08

Label at a glance#

ProductAmiodarone hydrochloride

Active ingredientAMIODARONE HYDROCHLORIDE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-840-06

Amiodarone Hydrochloride Tablets USP, 100 mg

30 Tablets

Rx only

NDC 65841-631-14 in bottle of 60 tablets

Amiodarone Hydrochloride Tablets, 200 mg

Rx only

NDC 65841-841-06

Amiodarone Hydrochloride Tablets USP, 400 mg

30 Tablets

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
835956	amiodarone HCl 100 MG Oral Tablet	PSN	10
833528	amiodarone HCl 200 MG Oral Tablet	PSN	10
834348	amiodarone HCl 400 MG Oral Tablet	PSN	10
835956	amiodarone hydrochloride 100 MG Oral Tablet	SCD	10
833528	amiodarone hydrochloride 200 MG Oral Tablet	SCD	10
834348	amiodarone hydrochloride 400 MG Oral Tablet	SCD	10

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
AMIODARONE Pharmacologic Class Indexing	4	Indexing - Pharmacologic Class	20230425

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
65841-631-05	Amiodarone hydrochloride	500 in 1 BOTTLE	TABLET	500	10
65841-631-06	Amiodarone hydrochloride	30 in 1 BOTTLE	TABLET	30	10
65841-631-10	Amiodarone hydrochloride	1000 in 1 BOTTLE	TABLET	1000	10
65841-631-14	Amiodarone hydrochloride	60 in 1 BOTTLE	TABLET	60	10
65841-631-77	Amiodarone hydrochloride	10 in 1 BLISTER PACK	TABLET	10	10
65841-631-77	Amiodarone hydrochloride	10 in 1 CARTON	TABLET	10	10
65841-840-06	Amiodarone hydrochloride	30 in 1 BOTTLE	TABLET	30	10
65841-841-06	Amiodarone hydrochloride	30 in 1 BOTTLE	TABLET	30	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65841-631	AMIODARONE HYDROCHLORIDE TABLET [ZYDUS LIFESCIENCES LIMITED]	10	Current NDC, Legacy NDC, 6 package rows	20241127_3e8db251-e3c5-4fba-be9a-6044a92f0beb.zip
65841-840	AMIODARONE HYDROCHLORIDE TABLET [ZYDUS LIFESCIENCES LIMITED]	10	Current NDC, 1 package rows	20241127_3e8db251-e3c5-4fba-be9a-6044a92f0beb.zip
65841-841	AMIODARONE HYDROCHLORIDE TABLET [ZYDUS LIFESCIENCES LIMITED]	10	Current NDC, 1 package rows	20241127_3e8db251-e3c5-4fba-be9a-6044a92f0beb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
AMIODARONE HYDROCHLORIDE	ACTIVE INGREDIENT	976728SY6Z	2
AMIODARONE	ACTIVE MOIETY	N3RQ532IUT	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Amiodarone hydrochloride
AMIODARONE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
STARCH, CORN
ALUMINUM OXIDE
D&C YELLOW NO. 10
FERRIC OXIDE RED
FERRIC OXIDE YELLOW

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65841-631	65841-631-06, 65841-631-14, 65841-631-05, 65841-631-10, 65841-631-77
65841-840	65841-840-06
65841-841	65841-841-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
AMIODARONE HYDROCHLORIDE	976728SY6Z	ACTIB
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
POVIDONE	FZ989GH94E	IACT
STARCH, CORN	O8232NY3SJ	IACT
AMIODARONE HYDROCHLORIDE	976728SY6Z	ACTIB
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
POVIDONE	FZ989GH94E	IACT
STARCH, CORN	O8232NY3SJ	IACT
AMIODARONE HYDROCHLORIDE	976728SY6Z	ACTIB
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
STARCH, CORN	O8232NY3SJ	IACT
POVIDONE	FZ989GH94E	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 50 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Maximum daily exposure	Match
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL	1116 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL	216 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL	1116 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL	216 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL	216 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL	4384 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL	4384 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL	4384 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL	216 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL	1116 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL	4384 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL	216 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL	4384 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL	1116 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL	216 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL	4384 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL	1116 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL	216 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL	1116 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL	1116 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL	216 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL	1116 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL	4384 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL	216 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL	4384 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL	216 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL	1116 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL	4384 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL	4384 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL	1116 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amiodarone hydrochloride	AMIODARONE HYDROCHLORIDE	Zydus Lifesciences Limited	3e8db251-e3c5-4fba-be9a-6044a92f0beb	2024-11-25		Exact identifier ndc (package): 65841-631-14 ndc (package): 65841-841-06 ndc (package): 65841-631-05 ndc (package): 65841-840-06 ndc (package): 65841-631-10 ndc (package): 65841-631-77 ndc (package): 65841-631-06 ndc (product): 65841-840 ndc (product): 65841-841 ndc (product): 65841-631 ndc11 (package): 65841063114 ndc11 (package): 65841063110 ndc11 (package): 65841063105 ndc11 (package): 65841084006 ndc11 (package): 65841063106 ndc11 (package): 65841063177 ndc11 (package): 65841084106 spl id: aabb5533-5d41-49a3-b8b6-14627af57311 spl set id: 3e8db251-e3c5-4fba-be9a-6044a92f0beb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.