FDA.reportPublic FDA data

Digoxin

Product NDC
0781-3059
11-digit product format
007813059
Labeler code
0781
Product ID
0781-3059_62ffbb27-b026-4fb2-b2a1-5c170036b8cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Digoxin
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; PARENTERAL
Labeler
Sandoz Inc
Application
ANDA040481
Marketing category
ANDA
Marketing start
2003-08-21
Substance
DIGOXIN
Active strength
250 ug/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
DIGOXIN250 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii73K4184T59
Rxcui104208

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
5c3aa978-6f46-c7ca-2a83-b57385976beeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-3059-72Digoxin2 mL in 1 AMPULEINJECTION, SOLUTION228
0781-3059-95Digoxin10 in 1 CARTONINJECTION, SOLUTION1028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3059-72ML - Milliliter0781-3059cd3c38ad-f9b0-4abc-af83-1bbde869cb1e12015-04-03
0781-3059-95ML - Milliliter0781-3059fa7386a2-12d0-4b52-a1d2-97cbe88223c112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIGOXINACTIVE INGREDIENT73K4184T59DIGOXIN INJECTION, SOLUTION [SANDOZ INC]16
DIGOXINACTIVE MOIETY73K4184T59DIGOXIN INJECTION, SOLUTION [SANDOZ INC]16
ALCOHOLINACTIVE INGREDIENT3K9958V90MDIGOXIN INJECTION, SOLUTION [SANDOZ INC]16
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDIGOXIN INJECTION, SOLUTION [SANDOZ INC]16
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIGOXIN INJECTION, SOLUTION [SANDOZ INC]16
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74DIGOXIN INJECTION, SOLUTION [SANDOZ INC]16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3059DIGOXIN INJECTION, SOLUTION [SANDOZ INC]27Current NDC, Legacy NDC, 2 package rows20241020_58f45aba-ff6f-43cc-bb88-be40a9f7beda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104208digoxin 500 MCG in 2 ML InjectionPSN58f45aba-ff6f-43cc-bb88-be40a9f7beda28
1042082 ML digoxin 0.25 MG/ML InjectionSCD58f45aba-ff6f-43cc-bb88-be40a9f7beda28
104208digoxin 500 MCG per 2 ML InjectionSY58f45aba-ff6f-43cc-bb88-be40a9f7beda28
104208digoxin 500 MCG in 2 ML InjectionPSN28f2c2cd-e58c-aea2-e063-6394a90a73e71
1042082 ML digoxin 0.25 MG/ML InjectionSCD28f2c2cd-e58c-aea2-e063-6394a90a73e71
104208digoxin 500 MCG per 2 ML InjectionSY28f2c2cd-e58c-aea2-e063-6394a90a73e71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-3059-72007813059722 mL in 1 AMPULE2 mlHistorical
0781-3059-950078130599510 AMPULE in 1 CARTON (0781-3059-95) / 2 mL in 1 AMPULE (0781-3059-72) 10 ampule2003-08-210000-00-00NoNoCurrent