FDA.reportPublic FDA data

Digoxin

Product NDC
57664-437
11-digit product format
576640437
Labeler code
57664
Product ID
57664-437_47e1a46c-562d-ac4c-e063-6294a90a9b81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Digoxin
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA076363
Marketing category
ANDA
Marketing start
2015-02-17
Substance
DIGOXIN
Active strength
125 ug/1
Pharmacologic classes
Cardiac Glycoside [EPC], Cardiac Glycosides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Digoxin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIGOXIN125 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57664-437-182020-08-05C16284748780-1ab0e2407-3557-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954
57664-437-882020-08-05C16284748780-1ab0e2407-3557-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954
57664-437-182020-07-22C16284748780-1ab0e2407-3557-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954
57664-437-882020-07-22C16284748780-1ab0e2407-3557-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57664-437-18Digoxin1000 in 1 BOTTLETABLET100014
57664-437-88Digoxin100 in 1 BOTTLETABLET10014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-437DIGOXIN TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]13Current NDC, Legacy NDC, 2 package rows20240608_62795623-a2bc-4dd2-8989-3b9782bfd80e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197604digoxin 125 MCG Oral TabletPSN5fb1bc4e-5806-4c50-aab0-91e445d87933103
197604digoxin 0.125 MG Oral TabletSCD5fb1bc4e-5806-4c50-aab0-91e445d87933103
197604digoxin 125 MCG Oral TabletSY5fb1bc4e-5806-4c50-aab0-91e445d87933103
197604digoxin 125 MCG Oral TabletPSN3d6afb9e-0c6c-40e1-ae26-6e544564ba444
197604digoxin 0.125 MG Oral TabletSCD3d6afb9e-0c6c-40e1-ae26-6e544564ba444
197604digoxin 125 MCG Oral TabletSY3d6afb9e-0c6c-40e1-ae26-6e544564ba444

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57664-437-18576640437181000 TABLET in 1 BOTTLE (57664-437-18) 1000 tablet2015-02-170000-00-00NoNoCurrent
57664-437-8857664043788100 TABLET in 1 BOTTLE (57664-437-88) 100 tablet2015-02-170000-00-00NoNoCurrent