Digoxin

Product NDC: 55289-002
11-digit product format: 552890002
Labeler code: 55289
Product ID: 55289-002_adb868f9-bd15-1215-e053-2a95a90a34ff
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Digoxin
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA076268
Marketing category: ANDA
Marketing start: 2002-07-26
Marketing end: 0000-00-00
Substance: DIGOXIN
Active strength: 125 ug/1
Pharmacologic classes: Cardiac Glycoside [EPC],Cardiac Glycosides [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	55289-002		D	Discontinued by firm	2026-08-07
excluded package	package	55289-002	55289-002-01	D	Discontinued by firm	2026-08-07
excluded package	package	55289-002	55289-002-30	D	Discontinued by firm	2026-08-07

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 1 · 36 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	55289-002-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55289-002-30	`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	55289-002-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55289-002-30	`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	55289-002-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55289-002-30	`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	55289-002-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55289-002-30	`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	55289-002-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55289-002-30	`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	55289-002-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55289-002-30	`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	55289-002-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55289-002-30	`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	55289-002-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55289-002-30	`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	55289-002-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55289-002-30	`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	55289-002-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55289-002-30	`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	55289-002-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55289-002-30	`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	55289-002-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55289-002-30	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 82 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
2026-02-19 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…`
2022-03-09 01:35 UTC	2022-03	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076268-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076268-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076268-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076268-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076268-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076268-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076268-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076268-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076268-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076268-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076268-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076268-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076268-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076268-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076268-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076268-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076268-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076268-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076268-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076268-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076268-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076268-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076268-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076268-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076268-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076268-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076268-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076268-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076268-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076268-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076268-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076268-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076268-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076268-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076268-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076268-002	AB	1	`74a2ff9319b5…`
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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55289-002-01	EA - Each	55289-002	61341040-de53-401c-b5a0-b1f9f08f1d71	1	2012-07-24
55289-002-30	EA - Each	55289-002	9a9aa28a-788a-4e95-98c5-65cd7b8bd958	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIGOXIN	ACTIVE INGREDIENT	73K4184T59	DIGOXIN TABLET [PD-RX PHARMACEUTICALS, INC.]	9
DIGOXIN	ACTIVE MOIETY	73K4184T59	DIGOXIN TABLET [PD-RX PHARMACEUTICALS, INC.]	9
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	DIGOXIN TABLET [PD-RX PHARMACEUTICALS, INC.]	9
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	DIGOXIN TABLET [PD-RX PHARMACEUTICALS, INC.]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIGOXIN TABLET [PD-RX PHARMACEUTICALS, INC.]	9
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DIGOXIN TABLET [PD-RX PHARMACEUTICALS, INC.]	9
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DIGOXIN TABLET [PD-RX PHARMACEUTICALS, INC.]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIGOXIN TABLET [PD-RX PHARMACEUTICALS, INC.]	9
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIGOXIN TABLET [PD-RX PHARMACEUTICALS, INC.]	9
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	DIGOXIN TABLET [PD-RX PHARMACEUTICALS, INC.]	9

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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
73K4184T59	DIGOXIN	20830-75-5	DIGOXIN

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
(Digoxin Tablets, USP) 125 mcg (0.125 mg)	PD-Rx Pharmaceuticals, Inc.	2020-08-25	HUMAN PRESCRIPTION DRUG LABEL	14