Digoxin

Product NDC: 71335-9610
Requested package NDC: 71335-9610-3
11-digit product format: 713359610
Labeler code: 71335
Product ID: 71335-9610_56ce5c02-95a6-43f4-84b2-f374ece3c0e2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Digoxin
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA076363
Marketing category: ANDA
Marketing start: 2015-02-17
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: 2024-12-31
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	71335-9610	71335-9610-3	D	Discontinued by firm		2026-10-05

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
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 · 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	A076363-001	DIGOXIN	0.125MG	TABLET / ORAL		2003-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076363-002	DIGOXIN	0.25MG	TABLET / ORAL		2003-01-31	`84e616aacf4f…`
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…`

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…`

Reported adverse events (FAERS/openFDA)#

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

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	SPL version
71335-9610-1	Digoxin	30 in 1 BOTTLE	TABLET	30	103
71335-9610-2	Digoxin	90 in 1 BOTTLE	TABLET	90	103
71335-9610-3	Digoxin	15 in 1 BOTTLE	TABLET	15	103
71335-9610-4	Digoxin	6 in 1 BOTTLE	TABLET	6	103
71335-9610-5	Digoxin	60 in 1 BOTTLE	TABLET	60	103
71335-9610-6	Digoxin	100 in 1 BOTTLE	TABLET	100	103
71335-9610-7	Digoxin	10 in 1 BOTTLE	TABLET	10	103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-9610	DIGOXIN TABLET [BRYANT RANCH PREPACK]	102	Legacy NDC, 7 package rows	20240727_5fb1bc4e-5806-4c50-aab0-91e445d87933.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197604	digoxin 125 MCG Oral Tablet	PSN	5fb1bc4e-5806-4c50-aab0-91e445d87933	103
197604	digoxin 0.125 MG Oral Tablet	SCD	5fb1bc4e-5806-4c50-aab0-91e445d87933	103
197604	digoxin 125 MCG Oral Tablet	SY	5fb1bc4e-5806-4c50-aab0-91e445d87933	103

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-9610-3	71335961003	15 TABLET in 1 BOTTLE (71335-9610-3)	15 tablet	2023-01-03	0000-00-00	No	No	Current