Digoxin

Product NDC
0904-5921
11-digit product format
009045921
Labeler code
0904
Product ID
0904-5921_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
125 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
DIGOXIN125 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
0904-5921-61Digoxin1 in 1 BLISTER PACKTABLET114
0904-5921-61Digoxin100 in 1 CARTONTABLET10014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5921-61EA - Each0904-5921854bf054-c6fd-464c-b8c4-1f57e3d67c8312012-07-24

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
DIGOXINACTIVE INGREDIENT73K4184T59DIGOXIN TABLET [CARDINAL HEALTH]1
DIGOXINACTIVE MOIETY73K4184T59DIGOXIN TABLET [CARDINAL HEALTH]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDIGOXIN TABLET [CARDINAL HEALTH]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDIGOXIN TABLET [CARDINAL HEALTH]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIGOXIN TABLET [CARDINAL HEALTH]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIGOXIN TABLET [CARDINAL HEALTH]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIGOXIN TABLET [CARDINAL HEALTH]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIGOXIN TABLET [CARDINAL HEALTH]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIGOXIN TABLET [CARDINAL HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-5921DIGOXIN 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
197604digoxin 125 MCG Oral TabletPSN51925501-ab5b-4e12-a67e-ec2b4b592e8314
197606digoxin 250 MCG Oral TabletPSN48cad559-c17b-4d41-a154-e664e958c1c014
197604digoxin 0.125 MG Oral TabletSCD48cad559-c17b-4d41-a154-e664e958c1c014
197604digoxin 0.125 MG Oral TabletSCD51925501-ab5b-4e12-a67e-ec2b4b592e8314
197606digoxin 0.25 MG Oral TabletSCD48cad559-c17b-4d41-a154-e664e958c1c014
197604digoxin 125 MCG Oral TabletSY48cad559-c17b-4d41-a154-e664e958c1c014
197604digoxin 125 MCG Oral TabletSY51925501-ab5b-4e12-a67e-ec2b4b592e8314
197606digoxin 250 MCG Oral TabletSY48cad559-c17b-4d41-a154-e664e958c1c014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-5921-6100904592161100 BLISTER PACK in 1 CARTON (0904-5921-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2009-06-100000-00-00NoNoCurrent