Digoxin

Product NDC
69238-1992
11-digit product format
692381992
Labeler code
69238
Product ID
69238-1992_e9480117-8eb3-41e7-8928-1573d3d21d0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Digoxin
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA076268
Marketing category
ANDA
Marketing start
2019-04-01
Substance
DIGOXIN
Active strength
250 ug/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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1992-1Digoxin100 in 1 BOTTLETABLET1006
69238-1992-7Digoxin1000 in 1 BOTTLETABLET10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1992-1EA - Each69238-1992c4842178-aa8c-44a7-863f-ce7d0ebd17ce12019-06-19
69238-1992-7EA - Each69238-1992f60c538c-237b-4feb-9cc7-5e835c992e7f12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1992DIGOXIN TABLET [AMNEAL PHARMACEUTICALS NY LLC]6Current NDC, Legacy NDC, 2 package rows20231230_f3d29508-e7cc-47ff-845d-b5375ee30407.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197604digoxin 125 MCG Oral TabletPSNf3d29508-e7cc-47ff-845d-b5375ee304076
197606digoxin 250 MCG Oral TabletPSNf3d29508-e7cc-47ff-845d-b5375ee304076
197604digoxin 0.125 MG Oral TabletSCDf3d29508-e7cc-47ff-845d-b5375ee304076
197606digoxin 0.25 MG Oral TabletSCDf3d29508-e7cc-47ff-845d-b5375ee304076
197604digoxin 125 MCG Oral TabletSYf3d29508-e7cc-47ff-845d-b5375ee304076
197606digoxin 250 MCG Oral TabletSYf3d29508-e7cc-47ff-845d-b5375ee304076
197606digoxin 250 MCG Oral TabletPSNb77043ef-fe00-4d12-9bda-0b82bfa7a0363
197606digoxin 0.25 MG Oral TabletSCDb77043ef-fe00-4d12-9bda-0b82bfa7a0363
197606digoxin 250 MCG Oral TabletSYb77043ef-fe00-4d12-9bda-0b82bfa7a0363

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1992-169238199201100 TABLET in 1 BOTTLE (69238-1992-1) 100 tablet2019-04-010000-00-00NoNoCurrent
69238-1992-7692381992071000 TABLET in 1 BOTTLE (69238-1992-7) 1000 tablet2019-04-010000-00-00NoNoCurrent