FDA.reportPublic FDA data

Digoxin

Product NDC
0143-1241
11-digit product format
001431241
Labeler code
0143
Product ID
0143-1241_935f4e33-109c-448c-822c-530145dbbc05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Digoxin
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA077002
Marketing category
ANDA
Marketing start
2007-10-30
Substance
DIGOXIN
Active strength
250 ug/1
Pharmacologic classes
Cardiac Glycoside [EPC], Cardiac Glycosides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Digoxin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIGOXIN250 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii73K4184T59
Rxcui197604, 197606

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-1241-01Digoxin100 in 1 BOTTLE, PLASTICTABLET10031
0143-1241-10Digoxin1000 in 1 BOTTLE, PLASTICTABLET100031
0143-1241-51Digoxin5000 in 1 BOTTLE, PLASTICTABLET500031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-1241-01EA - Each0143-1241a7f2310d-8838-4906-a616-821c0259efce12012-07-24
0143-1241-10EA - Each0143-1241b8d916a4-7856-400d-b452-51679711f18212012-07-24
0143-1241-51EA - Each0143-12413931021d-5154-45b0-be3f-ae9453dcc09e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIGOXINACTIVE INGREDIENT73K4184T59DIGOXIN TABLET [WEST-WARD PHARMACEUTICAL CORP]8
DIGOXINACTIVE MOIETY73K4184T59DIGOXIN TABLET [WEST-WARD PHARMACEUTICAL CORP]8
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDIGOXIN TABLET [WEST-WARD PHARMACEUTICAL CORP]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDIGOXIN TABLET [WEST-WARD PHARMACEUTICAL CORP]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIGOXIN TABLET [WEST-WARD PHARMACEUTICAL CORP]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIGOXIN TABLET [WEST-WARD PHARMACEUTICAL CORP]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIGOXIN TABLET [WEST-WARD PHARMACEUTICAL CORP]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIGOXIN TABLET [WEST-WARD PHARMACEUTICAL CORP]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIGOXIN TABLET [WEST-WARD PHARMACEUTICAL CORP]8
DIGOXINACTIVE INGREDIENT73K4184T59DIGOXIN TABLET [MAJOR PHARMACEUTICALS]4
DIGOXINACTIVE MOIETY73K4184T59DIGOXIN TABLET [MAJOR PHARMACEUTICALS]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDIGOXIN TABLET [MAJOR PHARMACEUTICALS]4
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIGOXIN TABLET [MAJOR PHARMACEUTICALS]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDIGOXIN TABLET [MAJOR PHARMACEUTICALS]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIGOXIN TABLET [MAJOR PHARMACEUTICALS]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIGOXIN TABLET [MAJOR PHARMACEUTICALS]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIGOXIN TABLET [MAJOR PHARMACEUTICALS]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIGOXIN TABLET [MAJOR PHARMACEUTICALS]4
DIGOXINACTIVE INGREDIENT73K4184T59DIGOXIN TABLET [PHYSICIANS TOTAL CARE, INC.]3
DIGOXINACTIVE MOIETY73K4184T59DIGOXIN TABLET [PHYSICIANS TOTAL CARE, INC.]3
DIGOXINACTIVE INGREDIENT73K4184T59DIGOXIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
DIGOXINACTIVE MOIETY73K4184T59DIGOXIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDIGOXIN 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
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIGOXIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIGOXIN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-1241DIGOXIN TABLET [HIKMA PHARMACEUTICALS USA INC.]31Current NDC, Legacy NDC, 3 package rows20240901_41c16cff-b03e-405e-a617-d6f45d3ce2bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197604digoxin 125 MCG Oral TabletPSN41c16cff-b03e-405e-a617-d6f45d3ce2bd31
197606digoxin 250 MCG Oral TabletPSN41c16cff-b03e-405e-a617-d6f45d3ce2bd31
197604digoxin 0.125 MG Oral TabletSCD41c16cff-b03e-405e-a617-d6f45d3ce2bd31
197606digoxin 0.25 MG Oral TabletSCD41c16cff-b03e-405e-a617-d6f45d3ce2bd31
197604digoxin 125 MCG Oral TabletSY41c16cff-b03e-405e-a617-d6f45d3ce2bd31
197606digoxin 250 MCG Oral TabletSY41c16cff-b03e-405e-a617-d6f45d3ce2bd31
197604digoxin 125 MCG Oral TabletPSN48cad559-c17b-4d41-a154-e664e958c1c014
197606digoxin 250 MCG Oral TabletPSN48cad559-c17b-4d41-a154-e664e958c1c014
197604digoxin 0.125 MG Oral TabletSCD48cad559-c17b-4d41-a154-e664e958c1c014
197606digoxin 0.25 MG Oral TabletSCD48cad559-c17b-4d41-a154-e664e958c1c014
197604digoxin 125 MCG Oral TabletSY48cad559-c17b-4d41-a154-e664e958c1c014
197606digoxin 250 MCG Oral TabletSY48cad559-c17b-4d41-a154-e664e958c1c014
197604digoxin 125 MCG Oral TabletPSN2636527a-1ecd-455f-a928-19549ac83fa112
197606digoxin 250 MCG Oral TabletPSN2636527a-1ecd-455f-a928-19549ac83fa112
197604digoxin 0.125 MG Oral TabletSCD2636527a-1ecd-455f-a928-19549ac83fa112
197606digoxin 0.25 MG Oral TabletSCD2636527a-1ecd-455f-a928-19549ac83fa112
197604digoxin 125 MCG Oral TabletSY2636527a-1ecd-455f-a928-19549ac83fa112
197606digoxin 250 MCG Oral TabletSY2636527a-1ecd-455f-a928-19549ac83fa112
197604digoxin 125 MCG Oral TabletPSN271ee022-0d8d-4c3b-928a-972708363bda3
197606digoxin 250 MCG Oral TabletPSN271ee022-0d8d-4c3b-928a-972708363bda3
197604digoxin 0.125 MG Oral TabletSCD271ee022-0d8d-4c3b-928a-972708363bda3
197606digoxin 0.25 MG Oral TabletSCD271ee022-0d8d-4c3b-928a-972708363bda3
197604digoxin 125 MCG Oral TabletSY271ee022-0d8d-4c3b-928a-972708363bda3
197606digoxin 250 MCG Oral TabletSY271ee022-0d8d-4c3b-928a-972708363bda3
197604digoxin 125 MCG Oral TabletPSN4f83feec-a1df-4175-8f9c-2e99d51b8e7b1
197606digoxin 250 MCG Oral TabletPSN26bafa77-ffe4-0bcb-e063-6394a90a80971
197606digoxin 250 MCG Oral TabletPSN4f83feec-a1df-4175-8f9c-2e99d51b8e7b1
197604digoxin 0.125 MG Oral TabletSCD4f83feec-a1df-4175-8f9c-2e99d51b8e7b1
197606digoxin 0.25 MG Oral TabletSCD26bafa77-ffe4-0bcb-e063-6394a90a80971
197606digoxin 0.25 MG Oral TabletSCD4f83feec-a1df-4175-8f9c-2e99d51b8e7b1
197604digoxin 125 MCG Oral TabletSY4f83feec-a1df-4175-8f9c-2e99d51b8e7b1
197606digoxin 250 MCG Oral TabletSY26bafa77-ffe4-0bcb-e063-6394a90a80971
197606digoxin 250 MCG Oral TabletSY4f83feec-a1df-4175-8f9c-2e99d51b8e7b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-1241-0100143124101100 TABLET in 1 BOTTLE, PLASTIC (0143-1241-01) 100 tablet2007-10-300000-00-00NoNoCurrent
0143-1241-10001431241101000 TABLET in 1 BOTTLE, PLASTIC (0143-1241-10) 1000 tablet2007-10-300000-00-00NoNoCurrent
0143-1241-51001431241515000 TABLET in 1 BOTTLE, PLASTIC (0143-1241-51) 5000 tablet2007-10-300000-00-00NoNoCurrent