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
774d8cd9-b67c-4808-acd7-4dd312e3afcc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 4, 2023
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
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 Code60687-551
Application NumberANDA076363
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 4, 2023
Generic NameDigoxin
INGREDIENTS (4)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DIGOXINActive
Quantity: 250 ug in 1 1
Code: 73K4184T59
Classification: ACTIB
Digoxin
PRODUCT DETAILS
NDC Product Code60687-540
Application NumberANDA076363
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 4, 2023
Generic NameDigoxin
INGREDIENTS (5)
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
DIGOXINActive
Quantity: 125 ug in 1 1
Code: 73K4184T59
Classification: ACTIB