DIGOXIN

Product NDC
53808-1006
11-digit product format
538081006
Labeler code
53808
Product ID
53808-1006_fa8c4fad-1802-44b5-9edc-4f45659dee69
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIGOXIN
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
NDA020405
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-11-01
Marketing end
0000-00-00
Substance
DIGOXIN
Active strength
0 mg/1
Pharmacologic classes
Cardiac Glycoside [EPC],Cardiac Glycosides [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct53808-1006IInactivated by FDA2026-08-07
excluded packagepackage53808-100653808-1006-1IInactivated by FDA2026-08-07

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53808-1006-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53808-1006-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53808-1006-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53808-1006-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53808-1006-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53808-1006-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53808-1006-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53808-1006-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53808-1006-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53808-1006-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53808-1006-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53808-1006-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53808-1006-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53808-1006-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53808-1006-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53808-1006-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53808-1006-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53808-1006-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53808-1006-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53808-1006-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53808-1006-19bebd1f3094a…5416666fcb17…

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020405-001LANOXINDIGOXIN0.0625MGTABLET / ORALABRLD1997-09-30
N020405-002LANOXINDIGOXIN0.125MGTABLET / ORALABRLD1997-09-30
N020405-003LANOXINDIGOXIN0.1875MGTABLET / ORALRLD1997-09-30
N020405-004LANOXINDIGOXIN0.25MGTABLET / ORALABRLD, RS1997-09-30
N020405-005LANOXINDIGOXIN0.375MGTABLET / ORAL1997-09-30
N020405-006LANOXINDIGOXIN0.5MGTABLET / ORAL1997-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020405-001AB
N020405-002AB
N020405-004AB

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 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020405-001LANOXIN0.0625MGTABLET / ORALABRLD1997-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020405-002LANOXIN0.125MGTABLET / ORALABRLD1997-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020405-003LANOXIN0.1875MGTABLET / ORALRLD1997-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020405-004LANOXIN0.25MGTABLET / ORALABRLD, RS1997-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020405-005LANOXIN0.375MGTABLET / ORAL1997-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020405-006LANOXIN0.5MGTABLET / ORAL1997-09-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020405-001LANOXIN0.0625MGTABLET / ORALABRLD1997-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020405-002LANOXIN0.125MGTABLET / ORALABRLD1997-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020405-003LANOXIN0.1875MGTABLET / ORALRLD1997-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020405-004LANOXIN0.25MGTABLET / ORALABRLD, RS1997-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020405-005LANOXIN0.375MGTABLET / ORAL1997-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020405-006LANOXIN0.5MGTABLET / ORAL1997-09-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N020405-001LANOXIN0.0625MGTABLET / ORALABRLD1997-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020405-002LANOXIN0.125MGTABLET / ORALABRLD1997-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020405-003LANOXIN0.1875MGTABLET / ORALRLD1997-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020405-004LANOXIN0.25MGTABLET / ORALABRLD, RS1997-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020405-005LANOXIN0.375MGTABLET / ORAL1997-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020405-006LANOXIN0.5MGTABLET / ORAL1997-09-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020405-001LANOXIN0.0625MGTABLET / ORALABRLD1997-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020405-002LANOXIN0.125MGTABLET / ORALABRLD1997-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020405-003LANOXIN0.1875MGTABLET / ORALRLD1997-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020405-004LANOXIN0.25MGTABLET / ORALABRLD, RS1997-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020405-005LANOXIN0.375MGTABLET / ORAL1997-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020405-006LANOXIN0.5MGTABLET / ORAL1997-09-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020405-001LANOXIN0.0625MGTABLET / ORALABRLD1997-09-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020405-002LANOXIN0.125MGTABLET / ORALABRLD1997-09-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020405-003LANOXIN0.1875MGTABLET / ORALRLD1997-09-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020405-004LANOXIN0.25MGTABLET / ORALABRLD, RS1997-09-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020405-005LANOXIN0.375MGTABLET / ORAL1997-09-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020405-006LANOXIN0.5MGTABLET / ORAL1997-09-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020405-001LANOXIN0.0625MGTABLET / ORALABRLD1997-09-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020405-002LANOXIN0.125MGTABLET / ORALABRLD1997-09-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020405-003LANOXIN0.1875MGTABLET / ORALRLD1997-09-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020405-004LANOXIN0.25MGTABLET / ORALABRLD, RS1997-09-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020405-005LANOXIN0.375MGTABLET / ORAL1997-09-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020405-006LANOXIN0.5MGTABLET / ORAL1997-09-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020405-001LANOXIN0.0625MGTABLET / ORALABRLD1997-09-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020405-002LANOXIN0.125MGTABLET / ORALABRLD1997-09-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020405-003LANOXIN0.1875MGTABLET / ORALRLD1997-09-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020405-004LANOXIN0.25MGTABLET / ORALABRLD, RS1997-09-302680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020405-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020405-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020405-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020405-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020405-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020405-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020405-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020405-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020405-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020405-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020405-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020405-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020405-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020405-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020405-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020405-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020405-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020405-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020405-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020405-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020405-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020405-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020405-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020405-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020405-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020405-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020405-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020405-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020405-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020405-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020405-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020405-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020405-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020405-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020405-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020405-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020405-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020405-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020405-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020405-001AB18072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
20d84de3-cb46-44c4-9211-63e833fa2688Product name220221214
4d74103a-bb9b-9034-fbc8-dac635e6e729Product name320221117
5c3aa978-6f46-c7ca-2a83-b57385976beeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-1006-1DIGOXIN30 in 1 BLISTER PACKTABLET301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIGOXINACTIVE INGREDIENT73K4184T59DIGOXIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
DIGOXINACTIVE MOIETY73K4184T59DIGOXIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDIGOXIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIGOXIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIGOXIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIGOXIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIGOXIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TDIGOXIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-1006DIGOXIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20150107_b69e2d2b-725c-4f2c-912d-d068da5c0f31.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LANOXINDIGOXINAdvanz Pharma (US) Corp.d91e3646-4c63-4512-ab22-db39c085c4dc2024-12-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 020405
application number: NDA020405
LANOXINDIGOXINAphena Pharma Solutions - Tennessee, LLCf6c7ca21-1c76-4838-8fb9-e1bec6001d8b2019-05-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 020405
application number: NDA020405

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197604digoxin 125 MCG Oral TabletPSNb69e2d2b-725c-4f2c-912d-d068da5c0f311
197604digoxin 0.125 MG Oral TabletSCDb69e2d2b-725c-4f2c-912d-d068da5c0f311
197604digoxin 125 MCG Oral TabletSYb69e2d2b-725c-4f2c-912d-d068da5c0f311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-1006-15380810060130 in 1 BLISTER PACKHistorical