DIGOX

Product NDC: 63187-740
11-digit product format: 631870740
Labeler code: 63187
Product ID: 63187-740_29702d54-0228-4f90-9360-4d1c4189754b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Digoxin
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA076268
Marketing category: ANDA
Marketing start: 2002-07-26
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: 2020-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63187-740		D	Discontinued by firm	2026-08-07
excluded package	package	63187-740	63187-740-10	D	Discontinued by firm	2026-08-07
excluded package	package	63187-740	63187-740-30	D	Discontinued by firm	2026-08-07
excluded package	package	63187-740	63187-740-60	D	Discontinued by firm	2026-08-07
excluded package	package	63187-740	63187-740-90	D	Discontinued by firm	2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-740-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-740-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-740-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-740-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-740-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-740-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-740-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-740-10	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 82 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
2026-02-19 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…`
2021-12-28 21:50 UTC	2021-12	A076268-001	DIGOXIN	0.125MG	TABLET / ORAL	AB	2002-07-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076268-002	DIGOXIN	0.25MG	TABLET / ORAL	AB	2002-07-26	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	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…`
2021-12-28 21:50 UTC	2021-12	A076268-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076268-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-740-10	EA - Each	63187-740	1779e901-e356-4acd-8a97-a6e919f3779c	1	2018-02-20
63187-740-90	EA - Each	63187-740	87cc2097-2743-4c4d-aa9f-5761b9cabd2e	1	2016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-740	DIGOX (DIGOXIN) TABLET [PROFICIENT RX LP]	4	Legacy NDC	20191121_f7015484-43cd-4654-8e11-5361106c92ac.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-740-10	63187074010	10 TABLET in 1 BOTTLE (63187-740-10)	10 tablet	2017-11-01	0000-00-00	No	No	Current
63187-740-30	63187074030	30 TABLET in 1 BOTTLE (63187-740-30)	30 tablet	2016-10-03	0000-00-00	No	No	Current
63187-740-60	63187074060	60 TABLET in 1 BOTTLE (63187-740-60)	60 tablet	2016-10-03	0000-00-00	No	No	Current
63187-740-90	63187074090	90 TABLET in 1 BOTTLE (63187-740-90)	90 tablet	2016-10-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DIGOX (Digoxin Tablets, USP) 125 mcg (0.125 mg) 250 mcg (0.25 mg)	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	4