Digoxin

Product NDC
59651-437
11-digit product format
596510437
Labeler code
59651
Product ID
59651-437_1338ce78-5a23-4dd2-bb1b-335f35cb2646
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Digoxin
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA214982
Marketing category
ANDA
Marketing start
2022-02-08
Substance
DIGOXIN
Active strength
.125 mg/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
DIGOXIN.125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii73K4184T59
Rxcui197604, 197606, 245273

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
59651-437-01Digoxin100 in 1 BOTTLETABLET1002
59651-437-99Digoxin1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-437-01EA - Each59651-43749692017-7494-4497-8ffa-66fbf4b5a66d12022-05-04
59651-437-99EA - Each59651-437b66fca74-ea5f-4447-9b5d-b7100ab0a89b12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-437DIGOXIN TABLET [AUROBINDO PHARMA LIMITED]2Current NDC, Legacy NDC, 2 package rows20240601_2bcd56ee-4497-4b8d-84db-a1470c77827b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197604digoxin 125 MCG Oral TabletPSNdbc0bc24-f250-47e8-8d10-6aef551823d75
197604digoxin 0.125 MG Oral TabletSCDdbc0bc24-f250-47e8-8d10-6aef551823d75
197604digoxin 125 MCG Oral TabletSYdbc0bc24-f250-47e8-8d10-6aef551823d75
197604digoxin 125 MCG Oral TabletPSN9f5f6254-2b3a-46ce-9b55-e5826caeed913
197604digoxin 0.125 MG Oral TabletSCD9f5f6254-2b3a-46ce-9b55-e5826caeed913
197604digoxin 125 MCG Oral TabletSY9f5f6254-2b3a-46ce-9b55-e5826caeed913
197604digoxin 125 MCG Oral TabletPSN2bcd56ee-4497-4b8d-84db-a1470c77827b2
197606digoxin 250 MCG Oral TabletPSN2bcd56ee-4497-4b8d-84db-a1470c77827b2
245273digoxin 62.5 MCG Oral TabletPSN2bcd56ee-4497-4b8d-84db-a1470c77827b2
245273digoxin 0.0625 MG Oral TabletSCD2bcd56ee-4497-4b8d-84db-a1470c77827b2
197604digoxin 0.125 MG Oral TabletSCD2bcd56ee-4497-4b8d-84db-a1470c77827b2
197606digoxin 0.25 MG Oral TabletSCD2bcd56ee-4497-4b8d-84db-a1470c77827b2
197604digoxin 125 MCG Oral TabletSY2bcd56ee-4497-4b8d-84db-a1470c77827b2
197606digoxin 250 MCG Oral TabletSY2bcd56ee-4497-4b8d-84db-a1470c77827b2
245273digoxin 62.5 MCG Oral TabletSY2bcd56ee-4497-4b8d-84db-a1470c77827b2
197604digoxin 125 MCG Oral TabletPSN1cfd4e43-56f0-d182-e063-6394a90ad2311
197604digoxin 0.125 MG Oral TabletSCD1cfd4e43-56f0-d182-e063-6394a90ad2311
197604digoxin 125 MCG Oral TabletSY1cfd4e43-56f0-d182-e063-6394a90ad2311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-437-0159651043701100 TABLET in 1 BOTTLE (59651-437-01) 100 tablet2022-02-080000-00-00NoNoCurrent
59651-437-99596510437991000 TABLET in 1 BOTTLE (59651-437-99) 1000 tablet2022-02-080000-00-00NoNoCurrent