FDA.reportPublic FDA data

Digoxin

Product NDC
0904-5922
11-digit product format
009045922
Labeler code
0904
Product ID
0904-5922_fad1e8b6-cb2e-46de-8f64-22de878e8028
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Digoxin
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA077002
Marketing category
ANDA
Marketing start
2009-06-10
Substance
DIGOXIN
Active strength
250 ug/1
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
DIGOXIN250 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii73K4184T59
Rxcui197604, 197606

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
0904-5922-61Digoxin100 in 1 CARTONTABLET10014
0904-5922-61Digoxin1 in 1 BLISTER PACKTABLET114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5922-60EA - Each0904-59228b562e09-bd3b-4160-b574-ded2b136e99712019-04-11
0904-5922-61EA - Each0904-5922ca16d3ff-81cd-4564-8714-6da1efddb3a012012-07-24
0904-5922-80EA - Each0904-59228fc00170-0867-4b2e-8581-f4da7f39381a12019-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIGOXINACTIVE INGREDIENT73K4184T59DIGOXIN TABLET [MAJOR PHARMACEUTICALS]4
DIGOXINACTIVE MOIETY73K4184T59DIGOXIN TABLET [MAJOR PHARMACEUTICALS]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDIGOXIN TABLET [MAJOR PHARMACEUTICALS]4
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIGOXIN TABLET [MAJOR PHARMACEUTICALS]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDIGOXIN TABLET [MAJOR PHARMACEUTICALS]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIGOXIN TABLET [MAJOR PHARMACEUTICALS]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIGOXIN TABLET [MAJOR PHARMACEUTICALS]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIGOXIN TABLET [MAJOR PHARMACEUTICALS]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIGOXIN TABLET [MAJOR PHARMACEUTICALS]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-5922DIGOXIN TABLET [MAJOR PHARMACEUTICALS]12Current NDC, Legacy NDC, 2 package rows20241212_48cad559-c17b-4d41-a154-e664e958c1c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197604digoxin 125 MCG Oral TabletPSN48cad559-c17b-4d41-a154-e664e958c1c014
197606digoxin 250 MCG Oral TabletPSN48cad559-c17b-4d41-a154-e664e958c1c014
197604digoxin 0.125 MG Oral TabletSCD48cad559-c17b-4d41-a154-e664e958c1c014
197606digoxin 0.25 MG Oral TabletSCD48cad559-c17b-4d41-a154-e664e958c1c014
197604digoxin 125 MCG Oral TabletSY48cad559-c17b-4d41-a154-e664e958c1c014
197606digoxin 250 MCG Oral TabletSY48cad559-c17b-4d41-a154-e664e958c1c014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-5922-6000904592260100 TABLET in 1 BOTTLE (0904-5922-60) 100 tablet2009-06-102021-07-31NoNoCurrent
0904-5922-6100904592261100 BLISTER PACK in 1 CARTON (0904-5922-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2009-06-100000-00-00NoNoCurrent
0904-5922-80009045922801000 TABLET in 1 BOTTLE (0904-5922-80) 1000 tablet2009-06-100000-00-00NoNoCurrent