Digoxin

Product NDC: 67046-1317
11-digit product format: 670461317
Labeler code: 67046
Product ID: 67046-1317_53e5a4dc-8479-42f5-e063-6294a90a0c08
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Digoxin
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA214982
Marketing category: ANDA
Marketing start: 2026-06-10
Substance: DIGOXIN
Active strength: .125 mg/1
Pharmacologic classes: Cardiac Glycoside [EPC], Cardiac Glycosides [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214982-001	DIGOXIN	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08
A214982-002	DIGOXIN	DIGOXIN	0.125MG	TABLET / ORAL	AB	2022-02-08
A214982-003	DIGOXIN	DIGOXIN	0.25MG	TABLET / ORAL	AB	2022-02-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A214982-001	AB
A214982-002	AB
A214982-003	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 · 102 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	A214982-001	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214982-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2022-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214982-003	DIGOXIN	0.25MG	TABLET / ORAL	AB	2022-02-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214982-001	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214982-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2022-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214982-003	DIGOXIN	0.25MG	TABLET / ORAL	AB	2022-02-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214982-001	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214982-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2022-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214982-003	DIGOXIN	0.25MG	TABLET / ORAL	AB	2022-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214982-001	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214982-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2022-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214982-003	DIGOXIN	0.25MG	TABLET / ORAL	AB	2022-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214982-001	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214982-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2022-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214982-003	DIGOXIN	0.25MG	TABLET / ORAL	AB	2022-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214982-001	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214982-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2022-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214982-003	DIGOXIN	0.25MG	TABLET / ORAL	AB	2022-02-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214982-001	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214982-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2022-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214982-003	DIGOXIN	0.25MG	TABLET / ORAL	AB	2022-02-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214982-001	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214982-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2022-02-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214982-003	DIGOXIN	0.25MG	TABLET / ORAL	AB	2022-02-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214982-001	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214982-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2022-02-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214982-003	DIGOXIN	0.25MG	TABLET / ORAL	AB	2022-02-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214982-001	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214982-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2022-02-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214982-003	DIGOXIN	0.25MG	TABLET / ORAL	AB	2022-02-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214982-001	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214982-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2022-02-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214982-003	DIGOXIN	0.25MG	TABLET / ORAL	AB	2022-02-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214982-001	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214982-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2022-02-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214982-003	DIGOXIN	0.25MG	TABLET / ORAL	AB	2022-02-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214982-001	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214982-002	DIGOXIN	0.125MG	TABLET / ORAL	AB	2022-02-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214982-003	DIGOXIN	0.25MG	TABLET / ORAL	AB	2022-02-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214982-001	DIGOXIN	0.0625MG	TABLET / ORAL	AB	2022-02-08	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A214982-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214982-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214982-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214982-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214982-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214982-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214982-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214982-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214982-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214982-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214982-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214982-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214982-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214982-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214982-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214982-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214982-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214982-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214982-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214982-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214982-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214982-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214982-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214982-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214982-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214982-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214982-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214982-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214982-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214982-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214982-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214982-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214982-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214982-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214982-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214982-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214982-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214982-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214982-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214982-001	AB	1	`301d65b070ca…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214982-001	CGT	2022-08-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214982-001	CGT	2022-08-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214982-001	CGT	2022-08-16	`4b0b4de00fa7…`
2023-01-26 05:58 UTC	2023-01	A214982-001	CGT	2022-08-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214982-001	CGT	2022-08-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214982-001	CGT	2022-08-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214982-001	CGT	2022-08-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214982-001	CGT	2022-08-16	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Digoxin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIGOXIN	.125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
73K4184T59	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197604	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
53e5aec1-052b-454e-e063-6394a90a87f3	Available on FDA.report

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Digoxin	DIGOXIN	Coupler LLC	53e5aec1-052b-454e-e063-6394a90a87f3	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214982 application number: ANDA214982 ndc (product): 67046-1317
Digoxin	DIGOXIN	REMEDYREPACK INC.	dbc0bc24-f250-47e8-8d10-6aef551823d7	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214982 application number: ANDA214982
Digoxin	DIGOXIN	REMEDYREPACK INC.	9ca08b66-55eb-4155-a8bd-6fa2282adab4	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214982 application number: ANDA214982
Digoxin	DIGOXIN	A-S Medication Solutions	9f5f6254-2b3a-46ce-9b55-e5826caeed91	2026-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214982 application number: ANDA214982
Digoxin	DIGOXIN	A-S Medication Solutions	ca595f0c-5bf0-4feb-8183-47832ee8c820	2026-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214982 application number: ANDA214982
Digoxin	DIGOXIN	AvPAK	1cfd4e43-56f0-d182-e063-6394a90ad231	2024-07-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214982 application number: ANDA214982
Digoxin	DIGOXIN	Aurobindo Pharma Limited	2bcd56ee-4497-4b8d-84db-a1470c77827b	2024-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214982 application number: ANDA214982

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	Sample	Exclude flag	Status
67046-1317-3	67046131703	30 TABLET in 1 BLISTER PACK (67046-1317-3)	30 tablet	2026-06-10	No	No	Current