FDA.reportPublic FDA data

Digoxin

Product NDC
17856-0057
11-digit product format
178560057
Labeler code
17856
Product ID
17856-0057_45b28de4-8c3d-5d99-e063-6294a90a9a95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Digoxin
Dosage form
SOLUTION
Route
ORAL
Labeler
Atlantic Biologicals Corps
Application
NDA021648
Marketing category
NDA
Marketing start
2004-08-26
Substance
DIGOXIN
Active strength
.05 mg/mL
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
DIGOXIN.05 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii73K4184T59
Rxcui393245

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
17856-0057-12025-05-27C16284748780-19d75b9d0-47ef-f424-e053-dadaa90a57ceDigoxin Oral Solution These highlights do not include all the information needed to use Digoxin Oral Solution safely and effectively. See full prescribing information for Digoxin Oral Solution. Initial U.S. Approval: 1982
17856-0057-52025-05-27C16284748780-19d75b9d0-47ef-f424-e053-dadaa90a57ceDigoxin Oral Solution These highlights do not include all the information needed to use Digoxin Oral Solution safely and effectively. See full prescribing information for Digoxin Oral Solution. Initial U.S. Approval: 1982
17856-0057-12020-01-31C16284748780-19d75b9d0-47ef-f424-e053-dadaa90a57ceDigoxin Oral Solution These highlights do not include all the information needed to use Digoxin Oral Solution safely and effectively. See full prescribing information for Digoxin Oral Solution. Initial U.S. Approval: 1982
17856-0057-52020-01-31C16284748780-19d75b9d0-47ef-f424-e053-dadaa90a57ceDigoxin Oral Solution These highlights do not include all the information needed to use Digoxin Oral Solution safely and effectively. See full prescribing information for Digoxin Oral Solution. Initial U.S. Approval: 1982

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0057-1Digoxin2.5 mL in 1 CUP, UNIT-DOSESOLUTION2.58
17856-0057-5Digoxin5 mL in 1 CUPSOLUTION58

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0057-1ML - Milliliter17856-0057e1bb1b5b-2885-4cce-996b-5a081be1a50812013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIGOXINACTIVE INGREDIENT73K4184T59DIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS]6
DIGOXINACTIVE MOIETY73K4184T59DIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS]6
ALCOHOLINACTIVE INGREDIENT3K9958V90MDIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS]6
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS]6
LIME (CITRUS)INACTIVE INGREDIENT8CZS546954DIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS]6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS]6
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS]6
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS]6
SORBITOLINACTIVE INGREDIENT506T60A25RDIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS]6
WATERINACTIVE INGREDIENT059QF0KO0RDIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0057DIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS]7Current NDC, Legacy NDC, 2 package rows20250529_dcf907d9-0f0e-4ecc-a555-7e6dcc08c166.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
393245digoxin 0.05 MG in 1 mL Oral SolutionPSNdcf907d9-0f0e-4ecc-a555-7e6dcc08c1668
393245digoxin 0.05 MG/ML Oral SolutionSCDdcf907d9-0f0e-4ecc-a555-7e6dcc08c1668
393245digoxin 50 MCG per 1 ML Oral SOlutionSYdcf907d9-0f0e-4ecc-a555-7e6dcc08c1668
393245digoxin 50 MCG/ML Oral SolutionSYdcf907d9-0f0e-4ecc-a555-7e6dcc08c1668

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17856-0057-1178560057012.5 mL in 1 CUP, UNIT-DOSE (17856-0057-1) 2.5 ml2011-12-05NoNoCurrent
17856-0057-5178560057055 mL in 1 CUP (17856-0057-5) 5 ml2018-09-24NoNoCurrent