FDA.reportPublic FDA data

Digoxin

Product NDC
0641-6184
11-digit product format
006416184
Labeler code
0641
Product ID
0641-6184_df632d39-a158-45dc-81db-649b1be8a736
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
20d84de3-cb46-44c4-9211-63e833fa2688Product name220221214
4d74103a-bb9b-9034-fbc8-dac635e6e729Product name320221117
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5c3aa978-6f46-c7ca-2a83-b57385976beeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6184-01Digoxin2 mL in 1 AMPULEINJECTION210
0641-6184-25Digoxin25 in 1 CARTONINJECTION2510

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIGOXINACTIVE INGREDIENT73K4184T59DIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]1
DIGOXINACTIVE MOIETY73K4184T59DIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MDIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]1
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37DIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]1
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FDIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RDIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6184DIGOXIN INJECTION [HIKMA PHARMACEUTICALS USA INC.]8Current NDC, Legacy NDC, 2 package rows20250327_9b9a4b3c-5f08-475a-a74d-0c7ebba40644.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104208digoxin 500 MCG in 2 ML InjectionPSN9b9a4b3c-5f08-475a-a74d-0c7ebba4064410
1042082 ML digoxin 0.25 MG/ML InjectionSCD9b9a4b3c-5f08-475a-a74d-0c7ebba4064410
104208digoxin 500 MCG per 2 ML InjectionSY9b9a4b3c-5f08-475a-a74d-0c7ebba4064410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-6184-01006416184012 mL in 1 AMPULE2 mlHistorical
0641-6184-250064161842525 AMPULE in 1 CARTON (0641-6184-25) / 2 mL in 1 AMPULE (0641-6184-01) 25 ampule1975-10-240000-00-00NoNoCurrent