Digoxin

Product NDC: 16714-591
Requested package NDC: 16714-591-01
11-digit product format: 167140591
Labeler code: 16714
Product ID: 16714-591_b6988d7b-4a9b-4c1a-b9e1-197ef632abb3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Digoxin
Dosage form: TABLET
Route: ORAL
Labeler: Northstar Rx LLC
Application: ANDA076363
Marketing category: ANDA
Marketing start: 2016-09-12
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	16714-591	16714-591-01	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
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 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
16714-591-01	2020-08-05	These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954
16714-591-01	2020-08-05	These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954
16714-591-02	2020-08-05	These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954
16714-591-02	2020-08-05	These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954
16714-591-01	2020-07-22	These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954
16714-591-01	2020-07-22	These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954
16714-591-02	2020-07-22	These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954
16714-591-02	2020-07-22	These highlights do not include all the information needed to use DIGOXIN TABLETS 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
16714-591-01	EA - Each	16714-591	f234320a-9efe-4b46-9add-969d98d3e556	1	2016-10-06
16714-591-02	EA - Each	16714-591	a0ee4437-1d25-49bb-9b5a-c32b430c6fd1	1	2016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-591	DIGOXIN TABLET [NORTHSTAR RX LLC]	8	Legacy NDC	20240627_8ec4abe0-7974-4921-b542-c9673dc5f77f.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197606	digoxin 250 MCG Oral Tablet	PSN	0a88434e-4a1b-4ade-a51e-38145e22a232	1
197606	digoxin 0.25 MG Oral Tablet	SCD	0a88434e-4a1b-4ade-a51e-38145e22a232	1
197606	digoxin 250 MCG Oral Tablet	SY	0a88434e-4a1b-4ade-a51e-38145e22a232	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-591-01	16714059101	100 TABLET in 1 BOTTLE (16714-591-01)	100 tablet	2016-09-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Digoxin	Northstar Rx LLC \| Sun Pharmaceutical Industries Limited	2025-10-08	HUMAN PRESCRIPTION DRUG LABEL	9
Digoxin	A-S Medication Solutions	2023-08-14	HUMAN PRESCRIPTION DRUG LABEL	1