FDA.reportPublic FDA data

Digoxin

Product NDC
57664-441
11-digit product format
576640441
Labeler code
57664
Product ID
57664-441_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
250 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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57664-441-182020-08-05C16284748780-1ab0e2407-3557-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
57664-441-882020-08-05C16284748780-1ab0e2407-3557-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
57664-441-182020-07-22C16284748780-1ab0e2407-3557-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
57664-441-882020-07-22C16284748780-1ab0e2407-3557-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
57664-441-18Digoxin1000 in 1 BOTTLETABLET100014
57664-441-88Digoxin100 in 1 BOTTLETABLET10014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-441DIGOXIN 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
197606digoxin 250 MCG Oral TabletPSNaea39b37-951e-49e8-9756-c763c0e7c7cd5
197606digoxin 0.25 MG Oral TabletSCDaea39b37-951e-49e8-9756-c763c0e7c7cd5
197606digoxin 250 MCG Oral TabletSYaea39b37-951e-49e8-9756-c763c0e7c7cd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57664-441-18576640441181000 TABLET in 1 BOTTLE (57664-441-18) 1000 tablet2015-02-170000-00-00NoNoCurrent
57664-441-8857664044188100 TABLET in 1 BOTTLE (57664-441-88) 100 tablet2015-02-170000-00-00NoNoCurrent