Amiodarone hydrochloride

Product NDC: 21695-796
11-digit product format: 216950796
Labeler code: 21695
Product ID: 21695-796_e1a80191-fcb5-4aab-a972-accabe6ae9c7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amiodarone hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA079029
Marketing category: ANDA
Marketing start: 2009-08-10
Marketing end: 0000-00-00
Substance: AMIODARONE HYDROCHLORIDE
Active strength: 200 mg/1
Pharmacologic classes: Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-796		I	Inactivated by FDA	2026-08-17
excluded package	package	21695-796	21695-796-30	I	Inactivated by FDA	2026-08-17
excluded package	package	21695-796	21695-796-90	I	Inactivated by FDA	2026-08-17

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 2 · 66 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-796-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-796-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-796-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-796-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-796-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-796-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-796-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-796-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-796-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-796-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-796-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-796-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-796-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-796-90	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-796-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-796-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-796-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-796-90	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-796-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-796-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-796-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-796-90	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-796-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-796-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-796-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-796-90	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-796-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-796-90	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-796-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-796-90	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-796-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-796-90	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-796-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-796-90	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-796-30	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-796-90	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-796-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-796-90	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-796-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-796-90	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 92 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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079029-002	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-01-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079029-003	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2023-01-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079029-001	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2008-09-16	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 92 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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079029-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079029-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079029-001	AB	1	`1e350fbaab3a…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-796-30	2019-09-24	C162847	48780-1	934fe258-4c23-48b1-e053-8cdaa90a720a	Amiodarone Hydrochloride Tablets
21695-796-90	2019-09-24	C162847	48780-1	934fe258-4c23-48b1-e053-8cdaa90a720a	Amiodarone Hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-796-30	Amiodarone hydrochloride	30 in 1 BOTTLE	TABLET	30		1
21695-796-90	Amiodarone hydrochloride	90 in 1 BOTTLE	TABLET	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-796-30	EA - Each	21695-796	53bb828f-07a4-419a-8c06-fe1f74c77b9e	1	2012-07-24
21695-796-90	EA - Each	21695-796	e8c9c214-1376-4655-a366-309f44d1e0ab	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMIODARONE HYDROCHLORIDE	ACTIVE INGREDIENT	976728SY6Z	AMIODARONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
AMIODARONE	ACTIVE MOIETY	N3RQ532IUT	AMIODARONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMIODARONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	AMIODARONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMIODARONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	AMIODARONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMIODARONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AMIODARONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-796	AMIODARONE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 2 package rows	20110414_e1a80191-fcb5-4aab-a972-accabe6ae9c7.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 · 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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
833528	amiodarone HCl 200 MG Oral Tablet	PSN	e1a80191-fcb5-4aab-a972-accabe6ae9c7	1
833528	amiodarone hydrochloride 200 MG Oral Tablet	SCD	e1a80191-fcb5-4aab-a972-accabe6ae9c7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-796-30	21695079630	30 in 1 BOTTLE	Historical
21695-796-90	21695079690	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amiodarone Hydrochloride Tablets	Rebel Distributors Corp	2011-04-13	HUMAN PRESCRIPTION DRUG LABEL	1