Digoxin
These highlights do not include all the information needed to use DIGOXIN TABLETS, USP safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954
Approved
Approval ID
41c16cff-b03e-405e-a617-d6f45d3ce2bd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 30, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Digoxin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-1240
Application NumberANDA077002
Product Classification
M
Marketing Category
C73584
G
Generic Name
Digoxin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (8)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
DIGOXINActive
Quantity: 125 ug in 1 1
Code: 73K4184T59
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
Digoxin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-1241
Application NumberANDA077002
Product Classification
M
Marketing Category
C73584
G
Generic Name
Digoxin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2023
FDA Product Classification
INGREDIENTS (6)
DIGOXINActive
Quantity: 250 ug in 1 1
Code: 73K4184T59
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT