Digoxin

Product NDC: 63629-3870
Requested package NDC: 63629-3870-3
11-digit product format: 636293870
Labeler code: 63629
Product ID: 63629-3870_badc96ff-8d82-49d8-929d-ee95c10abcf6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Digoxin
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA077002
Marketing category: ANDA
Marketing start: 2007-10-30
Marketing end: 0000-00-00
Substance: DIGOXIN
Active strength: 250 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63629-3870	63629-3870-3	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 · 14 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`

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
A077002-001	DIGOXIN	DIGOXIN	0.25MG	TABLET / ORAL	AB		2007-10-30
A077002-002	DIGOXIN	DIGOXIN	0.125MG	TABLET / ORAL	AB		2007-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077002-001	AB
A077002-002	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	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`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	A077002-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077002-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077002-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077002-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077002-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077002-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077002-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077002-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077002-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077002-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077002-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077002-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077002-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077002-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077002-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077002-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077002-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077002-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077002-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077002-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077002-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077002-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077002-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077002-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077002-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077002-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077002-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077002-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077002-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077002-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077002-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077002-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077002-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077002-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077002-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077002-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077002-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077002-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077002-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077002-002	AB	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-3870-1	2020-10-16	These highlights do not include all the information needed to use DIGOXIN TABLETS, USP safely and effectively. See full prescribing information for DIGOXIN TABLETS. Digoxin Tablets, for oral use Initial U.S. Approval: 1954
63629-3870-2	2020-10-16	These highlights do not include all the information needed to use DIGOXIN TABLETS, USP safely and effectively. See full prescribing information for DIGOXIN TABLETS. Digoxin Tablets, for oral use Initial U.S. Approval: 1954
63629-3870-3	2020-10-16	These highlights do not include all the information needed to use DIGOXIN TABLETS, USP safely and effectively. See full prescribing information for DIGOXIN TABLETS. Digoxin Tablets, for oral use Initial U.S. Approval: 1954
63629-3870-4	2020-10-16	These highlights do not include all the information needed to use DIGOXIN TABLETS, USP safely and effectively. See full prescribing information for DIGOXIN TABLETS. Digoxin Tablets, for oral use Initial U.S. Approval: 1954
63629-3870-1	2019-11-27	These highlights do not include all the information needed to use DIGOXIN TABLETS, USP safely and effectively. See full prescribing information for DIGOXIN TABLETS. Digoxin Tablets, for oral use Initial U.S. Approval: 1954
63629-3870-2	2019-11-27	These highlights do not include all the information needed to use DIGOXIN TABLETS, USP safely and effectively. See full prescribing information for DIGOXIN TABLETS. Digoxin Tablets, for oral use Initial U.S. Approval: 1954
63629-3870-3	2019-11-27	These highlights do not include all the information needed to use DIGOXIN TABLETS, USP safely and effectively. See full prescribing information for DIGOXIN TABLETS. Digoxin Tablets, for oral use Initial U.S. Approval: 1954
63629-3870-4	2019-11-27	These highlights do not include all the information needed to use DIGOXIN TABLETS, USP safely and effectively. See full prescribing information for DIGOXIN TABLETS. Digoxin Tablets, for oral use Initial U.S. Approval: 1954

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-3870-1	EA - Each	63629-3870	f2891189-ea71-4e7e-82c2-9bee668abae6	1	2013-02-13
63629-3870-2	EA - Each	63629-3870	ea61a8f2-7a80-4217-b0be-20865dfb7438	1	2013-02-13
63629-3870-3	EA - Each	63629-3870	af973162-003c-4ef2-9664-7bff958ccef2	1	2013-02-13
63629-3870-4	EA - Each	63629-3870	7b4a5d2b-8541-4e67-8f25-5ab71d85f83f	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIGOXIN	ACTIVE INGREDIENT	73K4184T59	DIGOXIN TABLET [BRYANT RANCH PREPACK]	1000
DIGOXIN	ACTIVE MOIETY	73K4184T59	DIGOXIN TABLET [BRYANT RANCH PREPACK]	1000
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	DIGOXIN TABLET [BRYANT RANCH PREPACK]	1000
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DIGOXIN TABLET [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIGOXIN TABLET [BRYANT RANCH PREPACK]	1000
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIGOXIN TABLET [BRYANT RANCH PREPACK]	1000
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DIGOXIN TABLET [BRYANT RANCH PREPACK]	1000

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Digoxin	DIGOXIN	NCS HealthCare of KY, LLC dba Vangard Labs	5886e233-b2da-4acb-be05-9bf40fb8e7f4	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077002 application number: ANDA077002
Digoxin	DIGOXIN	Golden State Medical Supply, Inc.	2636527a-1ecd-455f-a928-19549ac83fa1	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077002 application number: ANDA077002
Digoxin	DIGOXIN	Cardinal Health 107, LLC	51925501-ab5b-4e12-a67e-ec2b4b592e83	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077002 application number: ANDA077002
Digoxin	DIGOXIN	Major Pharmaceuticals	48cad559-c17b-4d41-a154-e664e958c1c0	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077002 application number: ANDA077002
Digoxin	DIGOXIN	Hikma Pharmaceuticals USA Inc.	41c16cff-b03e-405e-a617-d6f45d3ce2bd	2024-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077002 application number: ANDA077002

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-3870-3	63629387003	90 TABLET in 1 BOTTLE (63629-3870-3)	90 tablet	2008-10-31	0000-00-00	No	No	Current