FDA.reportPublic FDA data

Digoxin

Product NDC
50564-545
11-digit product format
505640545
Labeler code
50564
Product ID
50564-545_a95973ec-9445-4df0-8f10-2318719ccc43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Digoxin
Dosage form
TABLET
Route
ORAL
Labeler
Jerome Stevens Pharmaceuticals, Inc.
Application
ANDA076268
Marketing category
ANDA
Marketing start
2002-07-26
Marketing end
0000-00-00
Substance
DIGOXIN
Active strength
250 ug/1
Pharmacologic classes
Cardiac Glycoside [EPC],Cardiac Glycosides [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50564-545-012022-01-28C16284748780-1d6a99b39-d3a9-a426-e053-dadaa90af4c2Digoxin Tablets, USP 125 mcg (0.125 mg) 250 mcg (0.25 mg)
50564-545-102022-01-28C16284748780-1d6a99b39-d3a9-a426-e053-dadaa90af4c2Digoxin Tablets, USP 125 mcg (0.125 mg) 250 mcg (0.25 mg)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50564-545-01Digoxin100 in 1 BOTTLETABLET10013
50564-545-10Digoxin1000 in 1 BOTTLETABLET100013

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIGOXINACTIVE INGREDIENT73K4184T59DIGOXIN TABLET [JEROME STEVENS PHARMACEUTICALS, INC.]12
DIGOXINACTIVE MOIETY73K4184T59DIGOXIN TABLET [JEROME STEVENS PHARMACEUTICALS, INC.]12
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DIGOXIN TABLET [JEROME STEVENS PHARMACEUTICALS, INC.]12
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDIGOXIN TABLET [JEROME STEVENS PHARMACEUTICALS, INC.]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIGOXIN TABLET [JEROME STEVENS PHARMACEUTICALS, INC.]12
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DIGOXIN TABLET [JEROME STEVENS PHARMACEUTICALS, INC.]12
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDIGOXIN TABLET [JEROME STEVENS PHARMACEUTICALS, INC.]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIGOXIN TABLET [JEROME STEVENS PHARMACEUTICALS, INC.]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIGOXIN TABLET [JEROME STEVENS PHARMACEUTICALS, INC.]12
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDIGOXIN TABLET [JEROME STEVENS PHARMACEUTICALS, INC.]12
DIGOXINACTIVE INGREDIENT73K4184T59DIGOX (DIGOXIN) TABLET [CARILION MATERIALS MANAGEMENT]2
DIGOXINACTIVE MOIETY73K4184T59DIGOX (DIGOXIN) TABLET [CARILION MATERIALS MANAGEMENT]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDIGOX (DIGOXIN) TABLET [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIGOX (DIGOXIN) TABLET [CARILION MATERIALS MANAGEMENT]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DIGOX (DIGOXIN) TABLET [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIGOX (DIGOXIN) TABLET [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIGOX (DIGOXIN) TABLET [CARILION MATERIALS MANAGEMENT]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDIGOX (DIGOXIN) TABLET [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50564-545DIGOXIN TABLET [JEROME STEVENS PHARMACEUTICALS, INC.]13Legacy NDC, 2 package rows20200123_113fb426-9129-44e7-9d26-b1aa5e10513d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197604digoxin 125 MCG Oral TabletPSN113fb426-9129-44e7-9d26-b1aa5e10513d13
197606digoxin 250 MCG Oral TabletPSN113fb426-9129-44e7-9d26-b1aa5e10513d13
197604digoxin 0.125 MG Oral TabletSCD113fb426-9129-44e7-9d26-b1aa5e10513d13
197606digoxin 0.25 MG Oral TabletSCD113fb426-9129-44e7-9d26-b1aa5e10513d13
197604digoxin 125 MCG Oral TabletSY113fb426-9129-44e7-9d26-b1aa5e10513d13
197606digoxin 250 MCG Oral TabletSY113fb426-9129-44e7-9d26-b1aa5e10513d13
1245373Digox 250 MCG Oral TabletPSN7b64ac77-71a5-47e3-976e-9b5d7f7eb5306
197606digoxin 250 MCG Oral TabletPSN7b64ac77-71a5-47e3-976e-9b5d7f7eb5306
1245373digoxin 0.25 MG Oral Tablet [Digox]SBD7b64ac77-71a5-47e3-976e-9b5d7f7eb5306
197606digoxin 0.25 MG Oral TabletSCD7b64ac77-71a5-47e3-976e-9b5d7f7eb5306
1245373Digox 0.25 MG Oral TabletSY7b64ac77-71a5-47e3-976e-9b5d7f7eb5306
1245373Digox 250 MCG Oral TabletSY7b64ac77-71a5-47e3-976e-9b5d7f7eb5306
197606digoxin 250 MCG Oral TabletSY7b64ac77-71a5-47e3-976e-9b5d7f7eb5306
1245373Digox 250 MCG Oral TabletPSNc8c7482e-6276-4ec6-a7b9-365ab73bb99b2
197606digoxin 250 MCG Oral TabletPSNc8c7482e-6276-4ec6-a7b9-365ab73bb99b2
1245373digoxin 0.25 MG Oral Tablet [Digox]SBDc8c7482e-6276-4ec6-a7b9-365ab73bb99b2
197606digoxin 0.25 MG Oral TabletSCDc8c7482e-6276-4ec6-a7b9-365ab73bb99b2
1245373Digox 0.25 MG Oral TabletSYc8c7482e-6276-4ec6-a7b9-365ab73bb99b2
1245373Digox 250 MCG Oral TabletSYc8c7482e-6276-4ec6-a7b9-365ab73bb99b2
197606digoxin 250 MCG Oral TabletSYc8c7482e-6276-4ec6-a7b9-365ab73bb99b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50564-545-0150564054501100 TABLET in 1 BOTTLE (50564-545-01) 100 tablet2002-07-260000-00-00NoNoCurrent
50564-545-10505640545101000 TABLET in 1 BOTTLE (50564-545-10) 1000 tablet2002-07-260000-00-00NoNoCurrent