Digoxin

Product NDC
51655-001
11-digit product format
516550001
Labeler code
51655
Product ID
51655-001_a474a986-17f1-456b-b543-93c12314f147
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Digoxin
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals
Application
ANDA076268
Marketing category
ANDA
Marketing start
2014-05-16
Marketing end
0000-00-00
Substance
DIGOXIN
Active strength
0 mg/301
Pharmacologic classes
Cardiac Glycoside [EPC],Cardiac Glycosides [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51655-001DDiscontinued by firm2026-08-07
excluded packagepackage51655-00151655-001-52DDiscontinued by firm2026-08-07

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51655-001-52IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51655-001-52IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51655-001-52IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51655-001-52IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51655-001-52IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51655-001-52IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51655-001-52IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51655-001-52IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51655-001-52IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51655-001-52IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51655-001-52IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51655-001-52IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51655-001-52IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51655-001-52IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51655-001-52IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51655-001-52IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51655-001-52IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51655-001-52IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51655-001-52IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51655-001-52IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51655-001-52IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage51655-001-52EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076268-001DIGOXINDIGOXIN0.125MGTABLET / ORALAB2002-07-26
A076268-002DIGOXINDIGOXIN0.25MGTABLET / ORALAB2002-07-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076268-001AB
A076268-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076268-001DIGOXIN0.125MGTABLET / ORALAB2002-07-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076268-002DIGOXIN0.25MGTABLET / ORALAB2002-07-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076268-001DIGOXIN0.125MGTABLET / ORALAB2002-07-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076268-002DIGOXIN0.25MGTABLET / ORALAB2002-07-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A076268-001DIGOXIN0.125MGTABLET / ORALAB2002-07-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076268-002DIGOXIN0.25MGTABLET / ORALAB2002-07-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076268-001DIGOXIN0.125MGTABLET / ORALAB2002-07-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076268-002DIGOXIN0.25MGTABLET / ORALAB2002-07-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076268-001DIGOXIN0.125MGTABLET / ORALAB2002-07-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076268-002DIGOXIN0.25MGTABLET / ORALAB2002-07-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076268-001DIGOXIN0.125MGTABLET / ORALAB2002-07-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076268-002DIGOXIN0.25MGTABLET / ORALAB2002-07-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076268-001DIGOXIN0.125MGTABLET / ORALAB2002-07-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076268-002DIGOXIN0.25MGTABLET / ORALAB2002-07-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076268-001DIGOXIN0.125MGTABLET / ORALAB2002-07-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076268-002DIGOXIN0.25MGTABLET / ORALAB2002-07-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076268-001DIGOXIN0.125MGTABLET / ORALAB2002-07-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076268-002DIGOXIN0.25MGTABLET / ORALAB2002-07-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076268-001DIGOXIN0.125MGTABLET / ORALAB2002-07-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A076268-002DIGOXIN0.25MGTABLET / ORALAB2002-07-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076268-001DIGOXIN0.125MGTABLET / ORALAB2002-07-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076268-002DIGOXIN0.25MGTABLET / ORALAB2002-07-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076268-001DIGOXIN0.125MGTABLET / ORALAB2002-07-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076268-002DIGOXIN0.25MGTABLET / ORALAB2002-07-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076268-001DIGOXIN0.125MGTABLET / ORALAB2002-07-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076268-002DIGOXIN0.25MGTABLET / ORALAB2002-07-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076268-001DIGOXIN0.125MGTABLET / ORALAB2002-07-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076268-002DIGOXIN0.25MGTABLET / ORALAB2002-07-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076268-001DIGOXIN0.125MGTABLET / ORALAB2002-07-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076268-002DIGOXIN0.25MGTABLET / ORALAB2002-07-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076268-001DIGOXIN0.125MGTABLET / ORALAB2002-07-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076268-002DIGOXIN0.25MGTABLET / ORALAB2002-07-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076268-001DIGOXIN0.125MGTABLET / ORALAB2002-07-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076268-002DIGOXIN0.25MGTABLET / ORALAB2002-07-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076268-001DIGOXIN0.125MGTABLET / ORALAB2002-07-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076268-002DIGOXIN0.25MGTABLET / ORALAB2002-07-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076268-001DIGOXIN0.125MGTABLET / ORALAB2002-07-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076268-002DIGOXIN0.25MGTABLET / ORALAB2002-07-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076268-001DIGOXIN0.125MGTABLET / ORALAB2002-07-26782e0a99824c…
2021-12-28 21:50 UTC2021-12A076268-002DIGOXIN0.25MGTABLET / ORALAB2002-07-26782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076268-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076268-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076268-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076268-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076268-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076268-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076268-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076268-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076268-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076268-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076268-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076268-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076268-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076268-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076268-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076268-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076268-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076268-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076268-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076268-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076268-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076268-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076268-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076268-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076268-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076268-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076268-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076268-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076268-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076268-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076268-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076268-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076268-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076268-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076268-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076268-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076268-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076268-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076268-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A076268-002AB1782e0a99824c…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-001-522026-01-13C16284748780-19d75b9d1-2b44-f424-e053-dadaa90a57ce8daf4355-1562-47bb-9b4d-95e0f6696219
51655-001-522020-01-31C16284748780-19d75b9d1-2b44-f424-e053-dadaa90a57ce8daf4355-1562-47bb-9b4d-95e0f6696219

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIGOXINACTIVE INGREDIENT73K4184T59DIGOXIN TABLET [NORTHWIND PHARMACEUTICALS]1
DIGOXINACTIVE MOIETY73K4184T59DIGOXIN TABLET [NORTHWIND PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-001DIGOXIN TABLET [NORTHWIND PHARMACEUTICALS]1Legacy NDC20140520_8daf4355-1562-47bb-9b4d-95e0f6696219.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DigoxinDIGOXINBryant Ranch Prepacke61d2108-d871-44c0-b12a-2e61fbb569672026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076268
application number: ANDA076268
DigoxinDIGOXINBryant Ranch Prepackdcf9b23b-5840-46ff-bb61-c57a02831a032026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076268
application number: ANDA076268
DigoxinDIGOXINBryant Ranch Prepacke23bf2a6-1c24-44c4-8135-e469900f84b22026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076268
application number: ANDA076268
DigoxinDIGOXINOliva Therapeutics, LLC5b2d10d0-6e9d-4c39-a025-6b2f30ff62432026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076268
application number: ANDA076268
DigoxinDIGOXINProficient Rx LP42d079a7-def1-4220-b71f-db2651966ffe2025-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076268
application number: ANDA076268
DigoxinDIGOXINBryant Ranch Prepack03612934-62f4-4002-85af-6c66cd172acb2024-09-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076268
application number: ANDA076268
DigoxinDIGOXINBryant Ranch Prepack4b893a4a-31e6-4a7a-b16c-02b1e578335b2024-09-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076268
application number: ANDA076268
DigoxinDIGOXINAmneal Pharmaceuticals NY LLCf3d29508-e7cc-47ff-845d-b5375ee304072023-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076268
application number: ANDA076268