Application 076268

Type: ANDA
Sponsor: STEVENS J

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIGOXIN	DIGOXIN	TABLET;ORAL	0.125MG	No	No
002	DIGOXIN	DIGOXIN	TABLET;ORAL	0.25MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076268-001	DIGOXIN	DIGOXIN	0.125MG	TABLET / ORAL	AB		2002-07-26
A076268-002	DIGOXIN	DIGOXIN	0.25MG	TABLET / ORAL	AB		2002-07-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A076268-001	AB
A076268-002	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 · 86 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	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A076268-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076268-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076268-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076268-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076268-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076268-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076268-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076268-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076268-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076268-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076268-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076268-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076268-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076268-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076268-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076268-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076268-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076268-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076268-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076268-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076268-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A076268-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076268-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A076268-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076268-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076268-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076268-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076268-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076268-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076268-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076268-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076268-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076268-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A076268-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076268-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A076268-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076268-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076268-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076268-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A076268-002	AB	1	`f41ea6bd6efb…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Digoxin	DIGOXIN	Bryant Ranch Prepack	e61d2108-d871-44c0-b12a-2e61fbb56967	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076268 application number: ANDA076268
Digoxin	DIGOXIN	Bryant Ranch Prepack	dcf9b23b-5840-46ff-bb61-c57a02831a03	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076268 application number: ANDA076268
Digoxin	DIGOXIN	Bryant Ranch Prepack	e23bf2a6-1c24-44c4-8135-e469900f84b2	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076268 application number: ANDA076268
Digoxin	DIGOXIN	Oliva Therapeutics, LLC	5b2d10d0-6e9d-4c39-a025-6b2f30ff6243	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076268 application number: ANDA076268 ndc (product): 82685-202 ndc (product): 82685-201
Digoxin	DIGOXIN	Proficient Rx LP	42d079a7-def1-4220-b71f-db2651966ffe	2025-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076268 application number: ANDA076268
Digoxin	DIGOXIN	Bryant Ranch Prepack	03612934-62f4-4002-85af-6c66cd172acb	2024-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076268 application number: ANDA076268
Digoxin	DIGOXIN	Bryant Ranch Prepack	4b893a4a-31e6-4a7a-b16c-02b1e578335b	2024-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076268 application number: ANDA076268
Digoxin	DIGOXIN	Amneal Pharmaceuticals NY LLC	f3d29508-e7cc-47ff-845d-b5375ee30407	2023-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076268 application number: ANDA076268 ndc (product): 69238-1991 ndc (product): 69238-1992

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-1324	DIGOX	Digoxin	Lannett Company, Inc.	ANDA	Current
0527-1324	DIGOX	Digoxin	Lannett Company, Inc.	ANDA	Current
0527-1325	DIGOX	Digoxin	Lannett Company, Inc.	ANDA	Current
0527-1325	DIGOX	Digoxin	Lannett Company, Inc.	ANDA	Current
0615-7729	Digoxin	Digoxin	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7730	Digoxin	Digoxin	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
49999-181	DIGOX	Digoxin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50090-0432	Digoxin	Digoxin	A-S Medication Solutions	ANDA	Current
50090-0962	Digox	Digoxin	A-S Medication Solutions	ANDA	Current
50090-5276	Digoxin	Digoxin	A-S Medication Solutions	ANDA	Current
50090-5311	Digoxin	Digoxin	A-S Medication Solutions	ANDA	Current
50090-5311	Digoxin	Digoxin	A-S Medication Solutions	ANDA	Current
50436-0324	Digoxin	Digoxin	Unit Dose Services	ANDA	Current
50564-544	Digoxin	Digoxin	Jerome Stevens Pharmaceuticals, Inc.	ANDA	Current
50564-544	Digoxin	Digoxin	Jerome Stevens Pharmaceuticals, Inc.	ANDA	Current
50564-545	Digoxin	Digoxin	Jerome Stevens Pharmaceuticals, Inc.	ANDA	Current
50564-545	Digoxin	Digoxin	Jerome Stevens Pharmaceuticals, Inc.	ANDA	Current
51655-000	Digoxin	Digoxin	Northwind Pharmaceuticals	ANDA	Current
51655-001	Digoxin	Digoxin	Northwind Pharmaceuticals	ANDA	Current
53217-005	DIGOX	Digoxin	Aidarex Pharmaceuticals LLC	ANDA	Current
55289-002	Digoxin	Digoxin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-002	Digoxin	Digoxin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
63187-740	DIGOX	Digoxin	Proficient Rx LP	ANDA	Current
63187-740	DIGOX	Digoxin	Proficient Rx LP	ANDA	Current
64725-1324	DIGOX	Digoxin	TYA Pharmaceuticals	ANDA	Current
68151-1602	DIGOX	Digoxin	Carilion Materials Management	ANDA	Current
68151-1603	DIGOX	Digoxin	Carilion Materials Management	ANDA	Current
69238-1991	Digoxin	Digoxin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1991	Digoxin	Digoxin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1991	Digoxin	Digoxin	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1991	Digoxin	Digoxin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1992	Digoxin	Digoxin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1992	Digoxin	Digoxin	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1992	Digoxin	Digoxin	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1992	Digoxin	Digoxin	Amneal Pharmaceuticals NY LLC	ANDA	Current
71335-0159	Digoxin	Digoxin	Bryant Ranch Prepack	ANDA	Current
71335-0282	Digoxin	Digoxin	Bryant Ranch Prepack	ANDA	Current
71335-1540	Digoxin	Digoxin	Bryant Ranch Prepack	ANDA	Current
82685-201	Digoxin	Digoxin	Oliva Therapeutics, LLC	ANDA	Current
82685-201	Digoxin	Digoxin	Oliva Therapeutics, LLC	ANDA	Current
82685-202	Digoxin	Digoxin	Oliva Therapeutics, LLC	ANDA	Current
82685-202	Digoxin	Digoxin	Oliva Therapeutics, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43067	ORIG	2003-12-24
31106	ORIG	2003-12-24
18447	ORIG	2003-12-24