Digoxin

Product NDC: 60429-099
Requested package NDC: 60429-099-01
11-digit product format: 604290099
Labeler code: 60429
Product ID: 60429-099_4f7479fd-4d0b-666c-e063-6294a90a4fd9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Digoxin
Dosage form: TABLET
Route: ORAL
Labeler: Golden State Medical Supply, Inc.
Application: ANDA077002
Marketing category: ANDA
Marketing start: 2007-10-30
Marketing end: 2026-05-31
Substance: DIGOXIN
Active strength: 125 ug/1
Pharmacologic classes: Cardiac Glycoside [EPC], Cardiac Glycosides [CS]
NDC exclude flag: No
Current FDA listing: Yes

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	60429-099	60429-099-01	D	Discontinued by firm		2026-08-17

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
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 · 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	A077002-001	DIGOXIN	0.25MG	TABLET / ORAL	AB	2007-10-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077002-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2007-10-30	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A077002-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077002-002	AB	1	`caaa826d4ba7…`
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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
20d84de3-cb46-44c4-9211-63e833fa2688	Product name	2	20221214
4d74103a-bb9b-9034-fbc8-dac635e6e729	Product name	3	20221117
5c3aa978-6f46-c7ca-2a83-b57385976bee	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60429-099-01	Digoxin	100 in 1 BOTTLE, PLASTIC	TABLET	100		12
60429-099-10	Digoxin	1000 in 1 BOTTLE, PLASTIC	TABLET	1000		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60429-099-01	EA - Each	60429-099	95fe1ab9-46cf-4f42-aefa-52f9c3529755	1	2012-07-24
60429-099-10	EA - Each	60429-099	7aa3927e-3842-4cd7-a19a-a7ccaeb25657	1	2012-07-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60429-099	DIGOXIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	10	Current NDC, Legacy NDC, 2 package rows	20241027_2636527a-1ecd-455f-a928-19549ac83fa1.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 · 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 ndc (package): 60429-099-01 ndc (product): 60429-099 ndc11 (package): 60429009901
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197604	digoxin 125 MCG Oral Tablet	PSN	2636527a-1ecd-455f-a928-19549ac83fa1	12
197606	digoxin 250 MCG Oral Tablet	PSN	2636527a-1ecd-455f-a928-19549ac83fa1	12
197604	digoxin 0.125 MG Oral Tablet	SCD	2636527a-1ecd-455f-a928-19549ac83fa1	12
197606	digoxin 0.25 MG Oral Tablet	SCD	2636527a-1ecd-455f-a928-19549ac83fa1	12
197604	digoxin 125 MCG Oral Tablet	SY	2636527a-1ecd-455f-a928-19549ac83fa1	12
197606	digoxin 250 MCG Oral Tablet	SY	2636527a-1ecd-455f-a928-19549ac83fa1	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60429-099-01	60429009901	100 TABLET in 1 BOTTLE, PLASTIC (60429-099-01)	100 tablet	2019-08-02	2026-05-31	No	No	Current