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
dba3b3f7-3ff2-4996-8653-b0e54a398bf9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 27, 2022
Manufacturers
FDA
Novitium Pharma LLC
DUNS: 080301870
Products 3
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 Code70954-202
Application NumberANDA215307
Product Classification
M
Marketing Category
C73584
G
Generic Name
Digoxin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 27, 2022
FDA Product Classification
INGREDIENTS (5)
DIGOXINActive
Quantity: 0.250 mg in 1 1
Code: 73K4184T59
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Digoxin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70954-201
Application NumberANDA215307
Product Classification
M
Marketing Category
C73584
G
Generic Name
Digoxin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 27, 2022
FDA Product Classification
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
DIGOXINActive
Quantity: 0.125 mg in 1 1
Code: 73K4184T59
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
Digoxin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70954-200
Application NumberANDA215307
Product Classification
M
Marketing Category
C73584
G
Generic Name
Digoxin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 27, 2022
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
DIGOXINActive
Quantity: 0.0625 mg in 1 1
Code: 73K4184T59
Classification: ACTIB