Digoxin

Product NDC: 57664-441
Requested package NDC: 57664-441-88
11-digit product format: 576640441
Labeler code: 57664
Product ID: 57664-441_47e1a46c-562d-ac4c-e063-6294a90a9b81
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Digoxin
Dosage form: TABLET
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA076363
Marketing category: ANDA
Marketing start: 2015-02-17
Substance: DIGOXIN
Active strength: 250 ug/1
Pharmacologic classes: Cardiac Glycoside [EPC], Cardiac Glycosides [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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	57664-441	57664-441-88	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
57664-441-18	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
57664-441-88	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
57664-441-18	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
57664-441-88	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57664-441-18	Digoxin	1000 in 1 BOTTLE	TABLET	1000		14
57664-441-88	Digoxin	100 in 1 BOTTLE	TABLET	100		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57664-441-18	EA - Each	57664-441	806c781c-a9df-4f76-af1a-83c922c2f97d	1	2012-07-24
57664-441-88	EA - Each	57664-441	217210a2-9cdc-4564-a96b-47051507e013	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIGOXIN	ACTIVE INGREDIENT	73K4184T59	DIGOXIN TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5
DIGOXIN	ACTIVE MOIETY	73K4184T59	DIGOXIN TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DIGOXIN TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5
HYPROMELLOSE 2208 (15000 MPA.S)	INACTIVE INGREDIENT	Z78RG6M2N2	DIGOXIN TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DIGOXIN TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIGOXIN TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57664-441	DIGOXIN TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	13	Current NDC, Legacy NDC, 2 package rows	20240608_62795623-a2bc-4dd2-8989-3b9782bfd80e.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	aea39b37-951e-49e8-9756-c763c0e7c7cd	5
197606	digoxin 0.25 MG Oral Tablet	SCD	aea39b37-951e-49e8-9756-c763c0e7c7cd	5
197606	digoxin 250 MCG Oral Tablet	SY	aea39b37-951e-49e8-9756-c763c0e7c7cd	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57664-441-88	57664044188	100 TABLET in 1 BOTTLE (57664-441-88)	100 tablet	2015-02-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Digoxin	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	14
Digoxin	American Health Packaging	2025-01-07	HUMAN PRESCRIPTION DRUG LABEL	6
Digoxin	REMEDYREPACK INC.	2024-03-08	HUMAN PRESCRIPTION DRUG LABEL	5
Digoxin	A-S Medication Solutions	2023-11-24	HUMAN PRESCRIPTION DRUG LABEL	5