Digoxin

Product NDC: 60687-551
11-digit product format: 606870551
Labeler code: 60687
Product ID: 60687-551_ea3fda1e-efec-6d95-e053-2995a90adada
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Digoxin
Dosage form: TABLET
Route: ORAL
Labeler: American Health Packaging
Application: ANDA076363
Marketing category: ANDA
Marketing start: 2021-12-20
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: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	60687-551		D	Discontinued by firm		2026-08-17
excluded package	package	60687-551	60687-551-01	D	Discontinued by firm		2026-08-17

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	60687-551		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60687-551	60687-551-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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

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
A076363-001	DIGOXIN	DIGOXIN	0.125MG	TABLET / ORAL			2003-01-31
A076363-002	DIGOXIN	DIGOXIN	0.25MG	TABLET / ORAL			2003-01-31

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 · 84 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	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL		2003-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL		2003-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2003-01-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2003-01-31	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 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	A076363-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076363-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076363-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076363-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076363-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076363-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076363-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076363-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076363-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076363-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076363-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076363-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076363-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076363-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076363-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076363-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076363-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076363-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076363-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076363-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076363-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076363-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076363-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076363-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076363-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076363-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076363-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076363-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076363-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076363-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076363-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076363-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076363-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076363-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076363-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076363-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076363-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076363-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076363-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076363-002	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
60687-551-01	EA - Each	60687-551	7de6bdac-bda3-4699-84fe-cd3e1a66ba20	1	2022-01-06
60687-551-11	EA - Each	60687-551	4fbf2701-04fc-479e-9d74-45a4d0fd0182	1	2022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-551	DIGOXIN TABLET [AMERICAN HEALTH PACKAGING]	6	Legacy NDC	20250109_774d8cd9-b67c-4808-acd7-4dd312e3afcc.zip

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Digoxin	DIGOXIN	Bryant Ranch Prepack	5fb1bc4e-5806-4c50-aab0-91e445d87933	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076363 application number: ANDA076363
Digoxin	DIGOXIN	A-S Medication Solutions	3d6afb9e-0c6c-40e1-ae26-6e544564ba44	2024-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076363 application number: ANDA076363
Digoxin	DIGOXIN	A-S Medication Solutions	aea39b37-951e-49e8-9756-c763c0e7c7cd	2023-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076363 application number: ANDA076363
Digoxin	DIGOXIN	A-S Medication Solutions	0a88434e-4a1b-4ade-a51e-38145e22a232	2023-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076363 application number: ANDA076363

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
60687-551-01	60687055101	100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-551-01) > 1 TABLET in 1 BLISTER PACK (60687-551-11)	100 blister pack	2021-12-15	0000-00-00	No	No	Current