Digoxin

Product NDC: 82685-201
11-digit product format: 826850201
Labeler code: 82685
Product ID: 82685-201_48481a34-0b24-a796-e063-6294a90af307
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Digoxin
Dosage form: TABLET
Route: ORAL
Labeler: Oliva Therapeutics, LLC
Application: ANDA076268
Marketing category: ANDA
Marketing start: 2022-09-01
Substance: DIGOXIN
Active strength: 125 ug/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 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
A076268-001	DIGOXIN	DIGOXIN	0.125MG	TABLET / ORAL	AB		2002-07-26
A076268-002	DIGOXIN	DIGOXIN	0.25MG	TABLET / ORAL	AB		2002-07-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A076268-001	AB
A076268-002	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	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`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	A076268-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076268-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076268-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076268-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076268-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076268-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076268-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076268-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076268-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076268-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076268-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076268-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076268-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076268-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076268-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076268-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076268-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076268-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076268-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076268-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076268-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076268-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076268-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076268-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076268-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076268-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076268-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076268-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076268-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076268-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076268-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076268-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076268-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076268-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076268-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076268-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076268-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076268-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076268-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076268-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIGOXIN	125 ug/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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197604	Internal RxNorm lookup
197606	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
5b2d10d0-6e9d-4c39-a025-6b2f30ff6243	Available on FDA.report

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
82685-201-01	Digoxin	100 in 1 BOTTLE	TABLET	100		4
82685-201-10	Digoxin	1000 in 1 BOTTLE	TABLET	1000		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82685-201-01	EA - Each	82685-201	a4c8f68f-1ba1-43aa-a527-2b1eeaefc71f	1	2023-08-08
82685-201-10	EA - Each	82685-201	ca09d4a1-f55f-4ebb-9a72-009577967b54	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82685-201	DIGOXIN TABLET [OLIVA THERAPEUTICS, LLC]	3	Current NDC, Legacy NDC, 2 package rows	20230630_5b2d10d0-6e9d-4c39-a025-6b2f30ff6243.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Digoxin	DIGOXIN	Bryant Ranch Prepack	e61d2108-d871-44c0-b12a-2e61fbb56967	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076268 application number: ANDA076268
Digoxin	DIGOXIN	Bryant Ranch Prepack	dcf9b23b-5840-46ff-bb61-c57a02831a03	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076268 application number: ANDA076268
Digoxin	DIGOXIN	Bryant Ranch Prepack	e23bf2a6-1c24-44c4-8135-e469900f84b2	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076268 application number: ANDA076268
Digoxin	DIGOXIN	Oliva Therapeutics, LLC	5b2d10d0-6e9d-4c39-a025-6b2f30ff6243	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076268 application number: ANDA076268 ndc (product): 82685-201
Digoxin	DIGOXIN	Proficient Rx LP	42d079a7-def1-4220-b71f-db2651966ffe	2025-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076268 application number: ANDA076268
Digoxin	DIGOXIN	Bryant Ranch Prepack	03612934-62f4-4002-85af-6c66cd172acb	2024-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076268 application number: ANDA076268
Digoxin	DIGOXIN	Bryant Ranch Prepack	4b893a4a-31e6-4a7a-b16c-02b1e578335b	2024-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076268 application number: ANDA076268
Digoxin	DIGOXIN	Amneal Pharmaceuticals NY LLC	f3d29508-e7cc-47ff-845d-b5375ee30407	2023-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076268 application number: ANDA076268

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	e23bf2a6-1c24-44c4-8135-e469900f84b2	104
197604	digoxin 0.125 MG Oral Tablet	SCD	e23bf2a6-1c24-44c4-8135-e469900f84b2	104
197604	digoxin 125 MCG Oral Tablet	SY	e23bf2a6-1c24-44c4-8135-e469900f84b2	104
197604	digoxin 125 MCG Oral Tablet	PSN	4b893a4a-31e6-4a7a-b16c-02b1e578335b	100
197604	digoxin 0.125 MG Oral Tablet	SCD	4b893a4a-31e6-4a7a-b16c-02b1e578335b	100
197604	digoxin 125 MCG Oral Tablet	SY	4b893a4a-31e6-4a7a-b16c-02b1e578335b	100
197604	digoxin 125 MCG Oral Tablet	PSN	5b2d10d0-6e9d-4c39-a025-6b2f30ff6243	4
197606	digoxin 250 MCG Oral Tablet	PSN	5b2d10d0-6e9d-4c39-a025-6b2f30ff6243	4
197604	digoxin 0.125 MG Oral Tablet	SCD	5b2d10d0-6e9d-4c39-a025-6b2f30ff6243	4
197606	digoxin 0.25 MG Oral Tablet	SCD	5b2d10d0-6e9d-4c39-a025-6b2f30ff6243	4
197604	digoxin 125 MCG Oral Tablet	SY	5b2d10d0-6e9d-4c39-a025-6b2f30ff6243	4
197606	digoxin 250 MCG Oral Tablet	SY	5b2d10d0-6e9d-4c39-a025-6b2f30ff6243	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
82685-201-01	82685020101	100 TABLET in 1 BOTTLE (82685-201-01)	100 tablet	2022-09-01	0000-00-00	No	No	Current
82685-201-10	82685020110	1000 TABLET in 1 BOTTLE (82685-201-10)	1000 tablet	2022-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Digoxin	Bryant Ranch Prepack	2026-03-18	HUMAN PRESCRIPTION DRUG LABEL	104
Digoxin	Oliva Therapeutics, LLC	2026-01-13	HUMAN PRESCRIPTION DRUG LABEL	4
Digoxin	Bryant Ranch Prepack	2024-09-04	HUMAN PRESCRIPTION DRUG LABEL	100