FDA.reportPublic FDA data

Digoxin

Product NDC
0641-1410
11-digit product format
006411410
Labeler code
0641
Product ID
0641-1410_135cf10d-a417-45fa-a169-85a8bcec0bd2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Digoxin
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Digoxin
Listing expiration
2027-12-31

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
0641-1410-31Digoxin2 mL in 1 AMPULEINJECTION225
0641-1410-35Digoxin25 in 1 CARTONINJECTION2525

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-1410-31ML - Milliliter0641-14100f2f1428-8112-487f-aa27-07b325ac601912012-07-24
0641-1410-35ML - Milliliter0641-141081e89f85-4425-489d-acdf-b16ee1d1882a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIGOXINACTIVE INGREDIENT73K4184T59DIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]16
DIGOXINACTIVE MOIETY73K4184T59DIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]16
ALCOHOLINACTIVE INGREDIENT3K9958V90MDIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]16
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]16
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]16
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]16
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37DIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]16
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FDIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]16
WATERINACTIVE INGREDIENT059QF0KO0RDIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]16
digoxinACTIVE INGREDIENT73K4184T59DIGOXIN INJECTION [CARDINAL HEALTH]6
digoxinACTIVE MOIETY73K4184T59DIGOXIN INJECTION [CARDINAL HEALTH]6
alcoholINACTIVE INGREDIENT3K9958V90MDIGOXIN INJECTION [CARDINAL HEALTH]6
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDIGOXIN INJECTION [CARDINAL HEALTH]6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDIGOXIN INJECTION [CARDINAL HEALTH]6
propylene glycolINACTIVE INGREDIENT6DC9Q167V3DIGOXIN INJECTION [CARDINAL HEALTH]6
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37DIGOXIN INJECTION [CARDINAL HEALTH]6
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FDIGOXIN INJECTION [CARDINAL HEALTH]6
waterINACTIVE INGREDIENT059QF0KO0RDIGOXIN INJECTION [CARDINAL HEALTH]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-1410DIGOXIN INJECTION [HIKMA PHARMACEUTICALS USA INC.]24Current NDC, Legacy NDC, 2 package rows20250213_3933b07f-5857-4a80-b502-e3214bdf9330.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104208digoxin 500 MCG in 2 ML InjectionPSN3933b07f-5857-4a80-b502-e3214bdf933025
1042082 ML digoxin 0.25 MG/ML InjectionSCD3933b07f-5857-4a80-b502-e3214bdf933025
104208digoxin 500 MCG per 2 ML InjectionSY3933b07f-5857-4a80-b502-e3214bdf933025
104208digoxin 500 MCG in 2 ML InjectionPSN6aba2b38-5de0-4813-9775-39d87613893d15
1042082 ML digoxin 0.25 MG/ML InjectionSCD6aba2b38-5de0-4813-9775-39d87613893d15
104208digoxin 500 MCG per 2 ML InjectionSY6aba2b38-5de0-4813-9775-39d87613893d15
104208digoxin 500 MCG in 2 ML InjectionPSN75c99fc4-33b6-c3ce-e053-2991aa0a4d887
104208digoxin 500 MCG in 2 ML InjectionPSN98d2ad5b-9ffa-4456-9a01-567636c3a4d27
1042082 ML digoxin 0.25 MG/ML InjectionSCD75c99fc4-33b6-c3ce-e053-2991aa0a4d887
1042082 ML digoxin 0.25 MG/ML InjectionSCD98d2ad5b-9ffa-4456-9a01-567636c3a4d27
104208digoxin 500 MCG per 2 ML InjectionSY75c99fc4-33b6-c3ce-e053-2991aa0a4d887
104208digoxin 500 MCG per 2 ML InjectionSY98d2ad5b-9ffa-4456-9a01-567636c3a4d27
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 startMarketing endSampleExclude flagStatus
0641-1410-31006411410312 mL in 1 AMPULE2 mlHistorical
0641-1410-350064114103525 AMPULE in 1 CARTON (0641-1410-35) / 2 mL in 1 AMPULE (0641-1410-31) 25 ampule1975-10-240000-00-00NoNoCurrent