DIGOXIN
These highlights do not include all the information needed to use DIGOXIN safely and effectively. See full prescribing information for DIGOXIN. DIGOXIN (digoxin) tablets, for oral use Initial U.S. Approval: 1954
Approved
Approval ID
415b168c-121f-2777-e054-00144ff88e88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 22, 2020
Manufacturers
FDA
NuCare Pharmaceuticals, Inc.
DUNS: 010632300
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DIGOXIN
PRODUCT DETAILS
NDC Product Code66267-443
Application NumberNDA020405
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateJanuary 22, 2020
Generic NameDIGOXIN
INGREDIENTS (7)
STARCH, POTATOInactive
Code: 8I089SAH3T
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
DIGOXINActive
Quantity: 0.125 mg in 1 1
Code: 73K4184T59
Classification: ACTIB