Digoxin
These highlights do not include all the information needed to use Digoxin safely and effectively. See full prescribing information for Digoxin. Digoxin (Digoxin) TABLET for ORAL use. Initial U.S. Approval: 1954
Approved
Approval ID
5b2d10d0-6e9d-4c39-a025-6b2f30ff6243
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 26, 2023
Manufacturers
FDA
Oliva Therapeutics, LLC
DUNS: 118637856
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 Code82685-201
Application NumberANDA076268
Product Classification
M
Marketing Category
C73584
G
Generic Name
Digoxin
Product Specifications
Route of AdministrationORAL
Effective DateJune 26, 2023
FDA Product Classification
INGREDIENTS (7)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DIGOXINActive
Quantity: 125 ug in 1 1
Code: 73K4184T59
Classification: ACTIB
Digoxin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82685-202
Application NumberANDA076268
Product Classification
M
Marketing Category
C73584
G
Generic Name
Digoxin
Product Specifications
Route of AdministrationORAL
Effective DateJune 26, 2023
FDA Product Classification
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DIGOXINActive
Quantity: 250 ug in 1 1
Code: 73K4184T59
Classification: ACTIB