Application 078165

Type: ANDA
Sponsor: RUBICON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARVEDILOL	CARVEDILOL	TABLET;ORAL	3.125MG	No	No
002	CARVEDILOL	CARVEDILOL	TABLET;ORAL	6.25MG	No	No
003	CARVEDILOL	CARVEDILOL	TABLET;ORAL	12.5MG	No	No
004	CARVEDILOL	CARVEDILOL	TABLET;ORAL	25MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078165-001	CARVEDILOL	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05
A078165-002	CARVEDILOL	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05
A078165-003	CARVEDILOL	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05
A078165-004	CARVEDILOL	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A078165-001	AB
A078165-002	AB
A078165-003	AB
A078165-004	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 5 · 168 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	A078165-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078165-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078165-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078165-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078165-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078165-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078165-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078165-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078165-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078165-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078165-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078165-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078165-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078165-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078165-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078165-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078165-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078165-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078165-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078165-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078165-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078165-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078165-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078165-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078165-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078165-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078165-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078165-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078165-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078165-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078165-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078165-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078165-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078165-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078165-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078165-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078165-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078165-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078165-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078165-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	A078165-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078165-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078165-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078165-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078165-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078165-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078165-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078165-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078165-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078165-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078165-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078165-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078165-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078165-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078165-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078165-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078165-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078165-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078165-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078165-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078165-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078165-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078165-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078165-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078165-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078165-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078165-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078165-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078165-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078165-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078165-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078165-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078165-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078165-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078165-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078165-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078165-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078165-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078165-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078165-004	AB	1	`d8e5a09893c0…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CARVEDILOL	CARVEDILOL	PD-Rx Pharmaceuticals, Inc.	95300809-be15-461e-904e-b56aba676975	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078165 application number: ANDA078165
CARVEDILOL	CARVEDILOL	PD-Rx Pharmaceuticals, Inc.	9959f5d7-c363-4b8d-b8b9-7b45a8cb9aa9	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078165 application number: ANDA078165
CARVEDILOL	CARVEDILOL	NuCare Pharmaceuticals, Inc.	574c419f-3b9e-2171-e063-6394a90a0e90	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078165 application number: ANDA078165
CARVEDILOL	CARVEDILOL	Bryant Ranch Prepack	03b7c07c-14ba-40c8-8c0a-8dfa4a10f580	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078165 application number: ANDA078165 ndc (product): 71335-2026
CARVEDILOL	CARVEDILOL	Bryant Ranch Prepack	fe462198-32ae-4f6c-befc-acb97fb017c9	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078165 application number: ANDA078165 ndc (product): 71335-2033
CARVEDILOL	CARVEDILOL	Bryant Ranch Prepack	1ddff189-1848-4186-bca9-063e4ea7fd1f	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078165 application number: ANDA078165 ndc (product): 71335-2023
CARVEDILOL	CARVEDILOL	NuCare Pharmaceuticals, Inc.	4bbf3767-8666-22d8-e063-6294a90a2afe	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078165 application number: ANDA078165
CARVEDILOL	CARVEDILOL	Advagen Pharma Ltd	7a7d3ca1-05b0-4c7e-aefa-492cc441585d	2026-02-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078165 application number: ANDA078165 ndc (product): 72888-035 ndc (product): 72888-034 ndc (product): 72888-037 ndc (product): 72888-036
CARVEDILOL	CARVEDILOL	A-S Medication Solutions	5eeeaeee-9698-493f-9aa7-d13068147208	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078165 application number: ANDA078165
CARVEDILOL	CARVEDILOL	A-S Medication Solutions	947baca7-f9c8-4821-b47b-53c45288613e	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078165 application number: ANDA078165
CARVEDILOL	CARVEDILOL	Preferred Pharmaceuticals Inc.	8d3937b4-e0dd-4165-9825-bbf5020d79f9	2025-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078165 application number: ANDA078165 ndc (product): 68788-8231
CARVEDILOL	CARVEDILOL	RedPharm Drug, Inc	fcb1de7c-1878-1835-e053-6294a90abe95	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078165 application number: ANDA078165
CARVEDILOL	CARVEDILOL	RedPharm Drug, Inc	fcb2025f-11a1-ea73-e053-6394a90a61cb	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078165 application number: ANDA078165

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
68788-8177	CARVEDILOL	CARVEDILOL	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8231	CARVEDILOL	CARVEDILOL	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-3524	CARVEDILOL	CARVEDILOL	REMEDYREPACK INC.	ANDA	Current
71335-2023	CARVEDILOL	CARVEDILOL	Bryant Ranch Prepack	ANDA	Current
71335-2023	CARVEDILOL	CARVEDILOL	Bryant Ranch Prepack	ANDA	Current
71335-2026	CARVEDILOL	CARVEDILOL	Bryant Ranch Prepack	ANDA	Current
71335-2033	CARVEDILOL	CARVEDILOL	Bryant Ranch Prepack	ANDA	Current
72888-034	CARVEDILOL	CARVEDILOL	Advagen Pharma Ltd	ANDA	Current
72888-035	CARVEDILOL	CARVEDILOL	Advagen Pharma Ltd	ANDA	Current
72888-036	CARVEDILOL	CARVEDILOL	Advagen Pharma Ltd	ANDA	Current
72888-037	CARVEDILOL	CARVEDILOL	Advagen Pharma Ltd	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9127	ORIG	2007-09-07