Application 075135

Type: ANDA
Sponsor: UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PACERONE	AMIODARONE HYDROCHLORIDE	TABLET;ORAL	200MG	No	No
002	PACERONE	AMIODARONE HYDROCHLORIDE	TABLET;ORAL	100MG	No	No
003	PACERONE	AMIODARONE HYDROCHLORIDE	TABLET;ORAL	400MG	No	No

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
A075135-001	PACERONE	AMIODARONE HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1998-04-30
A075135-002	PACERONE	AMIODARONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-04-12
A075135-003	PACERONE	AMIODARONE HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2020-07-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075135-001	AB
A075135-002	AB
A075135-003	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 4 · 121 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	A075135-001	PACERONE	200MG	TABLET / ORAL	AB	1998-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075135-002	PACERONE	100MG	TABLET / ORAL	AB	2005-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075135-003	PACERONE	400MG	TABLET / ORAL	AB	2020-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075135-001	PACERONE	200MG	TABLET / ORAL	AB	1998-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075135-002	PACERONE	100MG	TABLET / ORAL	AB	2005-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075135-003	PACERONE	400MG	TABLET / ORAL	AB	2020-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075135-001	PACERONE	200MG	TABLET / ORAL	AB	1998-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075135-002	PACERONE	100MG	TABLET / ORAL	AB	2005-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075135-003	PACERONE	400MG	TABLET / ORAL	AB	2020-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075135-001	PACERONE	200MG	TABLET / ORAL	AB	1998-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075135-002	PACERONE	100MG	TABLET / ORAL	AB	2005-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075135-003	PACERONE	400MG	TABLET / ORAL	AB	2020-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075135-001	PACERONE	200MG	TABLET / ORAL	AB	1998-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075135-002	PACERONE	100MG	TABLET / ORAL	AB	2005-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075135-003	PACERONE	400MG	TABLET / ORAL	AB	2020-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075135-001	PACERONE	200MG	TABLET / ORAL	AB	1998-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075135-002	PACERONE	100MG	TABLET / ORAL	AB	2005-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075135-003	PACERONE	400MG	TABLET / ORAL	AB	2020-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075135-001	PACERONE	200MG	TABLET / ORAL	AB	1998-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075135-002	PACERONE	100MG	TABLET / ORAL	AB	2005-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075135-003	PACERONE	400MG	TABLET / ORAL	AB	2020-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075135-001	PACERONE	200MG	TABLET / ORAL	AB	1998-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075135-002	PACERONE	100MG	TABLET / ORAL	AB	2005-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075135-003	PACERONE	400MG	TABLET / ORAL	AB	2020-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075135-001	PACERONE	200MG	TABLET / ORAL	AB	1998-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075135-002	PACERONE	100MG	TABLET / ORAL	AB	2005-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075135-003	PACERONE	400MG	TABLET / ORAL	AB	2020-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075135-001	PACERONE	200MG	TABLET / ORAL	AB	1998-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075135-002	PACERONE	100MG	TABLET / ORAL	AB	2005-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075135-003	PACERONE	400MG	TABLET / ORAL	AB	2020-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075135-001	PACERONE	200MG	TABLET / ORAL	AB	1998-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075135-002	PACERONE	100MG	TABLET / ORAL	AB	2005-04-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075135-003	PACERONE	400MG	TABLET / ORAL	AB	2020-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075135-001	PACERONE	200MG	TABLET / ORAL	AB	1998-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075135-002	PACERONE	100MG	TABLET / ORAL	AB	2005-04-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075135-003	PACERONE	400MG	TABLET / ORAL	AB	2020-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075135-001	PACERONE	200MG	TABLET / ORAL	AB	1998-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075135-002	PACERONE	100MG	TABLET / ORAL	AB	2005-04-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075135-003	PACERONE	400MG	TABLET / ORAL	AB	2020-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075135-001	PACERONE	200MG	TABLET / ORAL	AB	1998-04-30	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 121 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	A075135-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075135-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075135-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075135-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075135-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075135-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075135-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075135-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075135-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075135-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075135-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075135-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075135-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075135-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075135-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075135-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075135-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075135-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075135-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075135-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075135-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075135-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075135-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075135-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075135-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075135-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075135-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075135-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075135-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075135-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075135-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075135-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075135-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075135-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075135-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075135-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075135-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075135-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075135-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075135-001	AB	1	`1e350fbaab3a…`

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
Pacerone	AMIODARONE HYDROCHLORIDE	Bryant Ranch Prepack	dcadce9c-d0a0-4235-8ff8-dd93c09e03b3	2025-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075135 application number: ANDA075135
Pacerone	AMIODARONE HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	4c4ec9b0-13a5-49a8-b57b-b3f64e4316a7	2025-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075135 application number: ANDA075135 ndc (product): 0245-0147 ndc (product): 0245-1645 ndc (product): 0245-0144
Pacerone	AMIODARONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	02f4a736-63ed-4ad4-a1f1-b21a71e928bd	2024-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075135 application number: ANDA075135

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0245-0144	Pacerone	Amiodarone Hydrochloride	Upsher-Smith Laboratories, LLC	ANDA	Current
0245-0144	Pacerone	Amiodarone Hydrochloride	Upsher-Smith Laboratories, LLC	ANDA	Current
0245-0147	Pacerone	Amiodarone Hydrochloride	Upsher-Smith Laboratories, LLC	ANDA	Current
0245-0147	Pacerone	Amiodarone Hydrochloride	Upsher-Smith Laboratories, LLC	ANDA	Current
0245-1645	Pacerone	Amiodarone Hydrochloride	Upsher-Smith Laboratories, LLC	ANDA	Current
55154-5606	Pacerone	Amiodarone Hydrochloride	Cardinal Health	ANDA	Current
55154-5606	Pacerone	Amiodarone Hydrochloride	Cardinal Health	ANDA	Current
55154-5606	Pacerone	Amiodarone Hydrochloride	Cardinal Health	ANDA	Current
65084-456	Pacerone	Amiodarone Hydrochloride	Mckesson Rxpak Inc	ANDA	Current
67544-570	Pacerone	Amiodarone Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
67544-570	Pacerone	Amiodarone Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43894	ORIG	2009-11-20
23758	ORIG	2005-08-01
42942	SUPPL	2002-10-29
42941	SUPPL	2002-10-29
42940	SUPPL	2002-10-29
22425	SUPPL	2002-10-29
22424	SUPPL	2002-10-29
22423	SUPPL	2002-10-29
22422	SUPPL	2002-10-29
8533	SUPPL	2000-02-01
8532	SUPPL	1999-12-02
30769	SUPPL	1999-09-24
22421	ORIG	1999-05-28
39456	ORIG	1998-04-30
30768	SUPPL	1998-04-30
30767	ORIG	1998-04-30