Digox
Digox
Approved
Approval ID
7b64ac77-71a5-47e3-976e-9b5d7f7eb530
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 29, 2018
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
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 Code50090-0962
Application NumberANDA076268
Product Classification
M
Marketing Category
C73584
G
Generic Name
Digoxin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 13, 2012
FDA Product Classification
INGREDIENTS (7)
DIGOXINActive
Quantity: 250 ug in 1 1
Code: 73K4184T59
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT