Digoxin

Manufacturer
Northwind Pharmaceuticals
Effective date
2014-05-16
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:36:12

Label at a glance#

ProductDigoxin
Active ingredientDIGOXIN
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 51655-000-52

MFG: 0527-1325-10

Digoxin 0.25 MG

30 Tablets

RX only

Lot# NW41860001

Exp. Date: 12/2015

Each tablet contains Digoxin, USP...0.25mg

Dosage: See package insert

Store at 68 to 77 degrees F.

Store in a tight, light resistant container (See USP).

Keep out of the reach of children.

Mfg: By: Jerome Stevens Pharmaceuticals Inc. Bohemia, NY 11716

MFG for: Lannett Co. Inc. Philadelphia, PA 19136 Lot#037213

Repacked by Northwind Pharmaceuticals, Indianapolis, IN 46256

Digoxin 0.25mg 51655-000Digoxin 0.25mg 51655-000

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-000-522026-01-13C16284748780-19d75b9d1-2b41-f424-e053-dadaa90a57ce1f079b17-12b5-4b51-961d-038502a7af0b
51655-000-522020-01-31C16284748780-19d75b9d1-2b41-f424-e053-dadaa90a57ce1f079b17-12b5-4b51-961d-038502a7af0b

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-000DIGOXIN TABLET [NORTHWIND PHARMACEUTICALS]1Legacy NDC20140520_1f079b17-12b5-4b51-961d-038502a7af0b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-1325-01EA - Each0527-1325183030d4-77aa-48bc-8b34-c5dd5bc9e56612012-07-24
0527-1325-10EA - Each0527-1325cecfbba6-944c-4f35-ae47-ef0eae0bcb4112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIGOXINACTIVE INGREDIENT73K4184T591
DIGOXINACTIVE MOIETY73K4184T591

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51655-00051655-000-52
0527-1325

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIGOXIN73K4184T59ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076268-001DIGOXIN0.125MGTABLET / ORALAB2002-07-2684e616aacf4f…
2026-09-14 22:38:342026-08A076268-002DIGOXIN0.25MGTABLET / ORALAB2002-07-2684e616aacf4f…
2026-08-18 06:07:402026-07A076268-001DIGOXIN0.125MGTABLET / ORALAB2002-07-26caaa826d4ba7…
2026-08-18 06:07:402026-07A076268-002DIGOXIN0.25MGTABLET / ORALAB2002-07-26caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A076268-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A076268-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A076268-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076268-002AB1caaa826d4ba7…
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…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
47e22236-5bda-4645-e063-6394a90a42961f079b17-12b5-4b51-961d-038502a7af0b2026-01-08Exact identifier
spl set id: 1f079b17-12b5-4b51-961d-038502a7af0b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.