DIGOXIN

Product NDC
49884-514
11-digit product format
498840514
Labeler code
49884
Product ID
49884-514_86c8d078-9090-4b77-adc6-49abfcdd74dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIGOXIN
Dosage form
TABLET
Route
ORAL
Labeler
Par Pharmaceutical Inc.
Application
NDA020405
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-01-14
Marketing end
2021-02-28
Substance
DIGOXIN
Active strength
0 mg/1
Pharmacologic classes
Cardiac Glycoside [EPC],Cardiac Glycosides [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49884-514DDiscontinued by firm2026-08-17
excluded packagepackage49884-51449884-514-01DDiscontinued by firm2026-08-17
excluded packagepackage49884-51449884-514-10DDiscontinued by firm2026-08-17

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 · 36 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 packagepackage49884-514-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49884-514-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49884-514-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49884-514-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49884-514-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49884-514-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49884-514-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49884-514-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49884-514-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49884-514-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49884-514-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49884-514-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49884-514-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49884-514-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49884-514-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49884-514-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49884-514-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49884-514-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49884-514-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49884-514-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49884-514-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49884-514-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49884-514-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49884-514-10557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020405-001LANOXIN0.0625MGTABLET / ORALABRLD1997-09-30caaa826d4ba7…
2026-08-18 06:07:402026-07N020405-002LANOXIN0.125MGTABLET / ORALABRLD1997-09-30caaa826d4ba7…
2026-08-18 06:07:402026-07N020405-003LANOXIN0.1875MGTABLET / ORALRLD1997-09-30caaa826d4ba7…
2026-08-18 06:07:402026-07N020405-004LANOXIN0.25MGTABLET / ORALABRLD, RS1997-09-30caaa826d4ba7…
2026-08-18 06:07:402026-07N020405-005LANOXIN0.375MGTABLET / ORAL1997-09-30caaa826d4ba7…
2026-08-18 06:07:402026-07N020405-006LANOXIN0.5MGTABLET / ORAL1997-09-30caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N020405-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020405-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020405-004AB1caaa826d4ba7…
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…

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-514-01EA - Each49884-51429085d29-2bc8-460e-bd70-95eaca050c2412014-02-04
49884-514-10EA - Each49884-51456b1cebb-ac5a-426f-a4b1-562b65627ef212014-02-04

DailyMed Socrata Ingredients#

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

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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-514-0149884051401100 TABLET in 1 BOTTLE (49884-514-01) 100 tablet2014-01-142021-02-28NoNoCurrent
49884-514-10498840514101000 TABLET in 1 BOTTLE (49884-514-10) 1000 tablet2014-01-142021-02-28NoNoCurrent