Digoxin

Product NDC
69238-1991
11-digit product format
692381991
Labeler code
69238
Product ID
69238-1991_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
125 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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1991-1Digoxin100 in 1 BOTTLETABLET1006
69238-1991-7Digoxin1000 in 1 BOTTLETABLET10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1991-1EA - Each69238-1991327442d7-8c1d-4eb4-92b8-9b725dea409a12019-06-19
69238-1991-7EA - Each69238-19919ba165bf-c492-48c3-952b-61c4b7c5ff3d12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1991DIGOXIN 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
197604digoxin 125 MCG Oral TabletPSNfb21e756-05bc-4d39-8199-6a2ce5e860db1
197604digoxin 0.125 MG Oral TabletSCDfb21e756-05bc-4d39-8199-6a2ce5e860db1
197604digoxin 125 MCG Oral TabletSYfb21e756-05bc-4d39-8199-6a2ce5e860db1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1991-169238199101100 TABLET in 1 BOTTLE (69238-1991-1) 100 tablet2019-04-010000-00-00NoNoCurrent
69238-1991-7692381991071000 TABLET in 1 BOTTLE (69238-1991-7) 1000 tablet2019-04-010000-00-00NoNoCurrent