Digoxin

Product NDC
84549-410
11-digit product format
845490410
Labeler code
84549
Product ID
84549-410_45b0d1e0-d1f5-28f6-e063-6394a90aaa51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Digoxin
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
ProPharma Distribution
Application
ANDA083391
Marketing category
ANDA
Marketing start
1975-10-24
Substance
DIGOXIN
Active strength
.25 mg/mL
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.25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii73K4184T59
Rxcui104208

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
20d84de3-cb46-44c4-9211-63e833fa2688Product name220221214
4d74103a-bb9b-9034-fbc8-dac635e6e729Product name320221117
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5c3aa978-6f46-c7ca-2a83-b57385976beeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84549-410-35Digoxin2 mL in 1 AMPULEINJECTION21

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104208digoxin 500 MCG in 2 ML InjectionPSN45b0d1e0-d1f6-28f6-e063-6394a90aaa511
1042082 ML digoxin 0.25 MG/ML InjectionSCD45b0d1e0-d1f6-28f6-e063-6394a90aaa511
104208digoxin 500 MCG per 2 ML InjectionSY45b0d1e0-d1f6-28f6-e063-6394a90aaa511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84549-410-35845490410352 mL in 1 AMPULE (84549-410-35) 2 ml2025-12-11NoNoHistorical