Digoxin
These highlights do not include all the information needed to use DIGOXIN ORAL SOLUTION safely and effectively. See full prescribing information for DIGOXIN ORAL SOLUTION. DIGOXIN oral solution Initial U.S. Approval: 1982
Approved
Approval ID
eda7193a-e139-41d5-a11b-dc6241645995
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 10, 2023
Manufacturers
FDA
Amici Pharma, Inc
DUNS: 119294414
FDA
Amici Pharmaceuticals, LLC
DUNS: 079536824
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 Code69292-605
Application NumberANDA215209
Product Classification
M
Marketing Category
C73584
G
Generic Name
Digoxin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 10, 2023
FDA Product Classification
INGREDIENTS (8)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ANHYDROUS TRISODIUM CITRATEInactive
Code: RS7A450LGA
Classification: IACT
DIGOXINActive
Quantity: 0.05 mg in 1 mL
Code: 73K4184T59
Classification: ACTIB
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT