FDA.reportPublic FDA data

LANOXIN

Product NDC
59212-249
11-digit product format
592120249
Labeler code
59212
Product ID
59212-249_3a39029f-2e63-4894-8a0d-45e122f5047b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
digoxin
Dosage form
TABLET
Route
ORAL
Labeler
Advanz Pharma (US) Corp.
Application
NDA020405
Marketing category
NDA
Marketing start
2012-09-30
Substance
DIGOXIN
Active strength
.25 mg/1
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
LANOXIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIGOXIN.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii73K4184T59
Rxcui104206, 197604, 197606, 245273, 309888, 309889, 1441565, 1441567

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
59212-249-55LANOXIN100 in 1 BOTTLETABLET10012
59212-249-56LANOXIN10 in 1 BLISTER PACKTABLET1012
59212-249-56LANOXIN10 in 1 CARTONTABLET1012
59212-249-75LANOXIN1000 in 1 BOTTLETABLET100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59212-249-55EA - Each59212-2494bb0b55b-cb59-4238-8842-47ad2aeaad2112016-01-13
59212-249-56EA - Each59212-2498a736845-b3de-4628-86fa-453daa876f5412016-03-04
59212-249-75EA - Each59212-2491c50c5b4-e197-4509-b4e5-59efdad0046812017-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIGOXINACTIVE INGREDIENT73K4184T59LANOXIN (DIGOXIN) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
DIGOXINACTIVE MOIETY73K4184T59LANOXIN (DIGOXIN) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
D&C GREEN NO. 5INACTIVE INGREDIENT8J6RDU8L9XLANOXIN (DIGOXIN) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLANOXIN (DIGOXIN) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LANOXIN (DIGOXIN) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLANOXIN (DIGOXIN) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LANOXIN (DIGOXIN) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLANOXIN (DIGOXIN) TABLET [CONCORDIA PHARMACEUTICALS INC.]1
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TLANOXIN (DIGOXIN) TABLET [CONCORDIA PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59212-249LANOXIN (DIGOXIN) TABLET [ADVANZ PHARMA (US) CORP.]12Current NDC, Legacy NDC, 4 package rows20250109_d91e3646-4c63-4512-ab22-db39c085c4dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197604digoxin 125 MCG Oral TabletPSNd91e3646-4c63-4512-ab22-db39c085c4dc12
1441565digoxin 187.5 MCG Oral TabletPSNd91e3646-4c63-4512-ab22-db39c085c4dc12
197606digoxin 250 MCG Oral TabletPSNd91e3646-4c63-4512-ab22-db39c085c4dc12
245273digoxin 62.5 MCG Oral TabletPSNd91e3646-4c63-4512-ab22-db39c085c4dc12
309888LANOXIN 125 MCG Oral TabletPSNd91e3646-4c63-4512-ab22-db39c085c4dc12
1441567LANOXIN 187.5 MCG Oral TabletPSNd91e3646-4c63-4512-ab22-db39c085c4dc12
309889LANOXIN 250 MCG Oral TabletPSNd91e3646-4c63-4512-ab22-db39c085c4dc12
104206LANOXIN 62.5 MCG Oral TabletPSNd91e3646-4c63-4512-ab22-db39c085c4dc12
104206digoxin 0.0625 MG Oral Tablet [Lanoxin]SBDd91e3646-4c63-4512-ab22-db39c085c4dc12
309888digoxin 0.125 MG Oral Tablet [Lanoxin]SBDd91e3646-4c63-4512-ab22-db39c085c4dc12
1441567digoxin 0.1875 MG Oral Tablet [Lanoxin]SBDd91e3646-4c63-4512-ab22-db39c085c4dc12
309889digoxin 0.25 MG Oral Tablet [Lanoxin]SBDd91e3646-4c63-4512-ab22-db39c085c4dc12
245273digoxin 0.0625 MG Oral TabletSCDd91e3646-4c63-4512-ab22-db39c085c4dc12
197604digoxin 0.125 MG Oral TabletSCDd91e3646-4c63-4512-ab22-db39c085c4dc12
1441565digoxin 0.1875 MG Oral TabletSCDd91e3646-4c63-4512-ab22-db39c085c4dc12
197606digoxin 0.25 MG Oral TabletSCDd91e3646-4c63-4512-ab22-db39c085c4dc12
1441565digoxin 0.1875 MG Oral TabletsSYd91e3646-4c63-4512-ab22-db39c085c4dc12
197604digoxin 125 MCG Oral TabletSYd91e3646-4c63-4512-ab22-db39c085c4dc12
1441565digoxin 187.5 MCG Oral TabletSYd91e3646-4c63-4512-ab22-db39c085c4dc12
197606digoxin 250 MCG Oral TabletSYd91e3646-4c63-4512-ab22-db39c085c4dc12
245273digoxin 62.5 MCG Oral TabletSYd91e3646-4c63-4512-ab22-db39c085c4dc12
309888Lanoxin 0.125 MG Oral TabletSYd91e3646-4c63-4512-ab22-db39c085c4dc12
1441567Lanoxin 0.188 MG Oral TabletSYd91e3646-4c63-4512-ab22-db39c085c4dc12
309889Lanoxin 0.25 MG Oral TabletSYd91e3646-4c63-4512-ab22-db39c085c4dc12
309888Lanoxin 125 MCG Oral TabletSYd91e3646-4c63-4512-ab22-db39c085c4dc12
1441567Lanoxin 187.5 MCG Oral TabletSYd91e3646-4c63-4512-ab22-db39c085c4dc12
309889Lanoxin 250 MCG Oral TabletSYd91e3646-4c63-4512-ab22-db39c085c4dc12
104206Lanoxin 62.5 MCG Oral TabletSYd91e3646-4c63-4512-ab22-db39c085c4dc12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59212-249-5559212024955100 TABLET in 1 BOTTLE (59212-249-55) 100 tablet2012-09-300000-00-00NoNoCurrent
59212-249-565921202495610 in 1 BLISTER PACKHistorical
59212-249-75592120249751000 in 1 BOTTLEHistorical