Digoxin
These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954
Approved
Approval ID
dfac7f13-28be-423d-9389-9089da29da17
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 1, 2019
Manufacturers
FDA
Amneal Pharmaceuticals of New York LLC
DUNS: 123797875
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DIGOXIN
PRODUCT DETAILS
NDC Product Code0115-9822
Application NumberANDA078556
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 1, 2019
Generic NameDIGOXIN
INGREDIENTS (5)
DIGOXINActive
Quantity: 250 ug in 1 1
Code: 73K4184T59
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DIGOXIN
PRODUCT DETAILS
NDC Product Code0115-9811
Application NumberANDA078556
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 1, 2019
Generic NameDIGOXIN
INGREDIENTS (6)
DIGOXINActive
Quantity: 125 ug in 1 1
Code: 73K4184T59
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT