Digoxin

Product NDC
71335-2463
11-digit product format
713352463
Labeler code
71335
Product ID
71335-2463_c67fa3b0-0841-45ca-bbc0-749570bfc8fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Digoxin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076268
Marketing category
ANDA
Marketing start
2022-09-01
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

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
71335-2463-1Digoxin1000 in 1 BOTTLETABLET1000100
71335-2463-2Digoxin100 in 1 BOTTLETABLET100100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2463-1EA - Each71335-2463102f759b-279a-49f0-9ed6-037c284775e212024-10-04
71335-2463-2EA - Each71335-246397c41b33-3ce2-4937-ae0c-ea6854e59d3412024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2463DIGOXIN TABLET [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20240906_4b893a4a-31e6-4a7a-b16c-02b1e578335b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197604digoxin 125 MCG Oral TabletPSN4b893a4a-31e6-4a7a-b16c-02b1e578335b100
197604digoxin 0.125 MG Oral TabletSCD4b893a4a-31e6-4a7a-b16c-02b1e578335b100
197604digoxin 125 MCG Oral TabletSY4b893a4a-31e6-4a7a-b16c-02b1e578335b100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2463-1713352463011000 TABLET in 1 BOTTLE (71335-2463-1) 1000 tablet2024-09-04NoNoHistorical
71335-2463-271335246302100 TABLET in 1 BOTTLE (71335-2463-2) 100 tablet2024-09-04NoNoHistorical