Digoxin
These highlights do not include all the information needed to use DIGOXIN INJECTION safely and effectively. See full prescribing information for DIGOXIN INJECTION. DIGOXIN injection, for intravenous or intramuscular useInitial U.S. Approval: 1954
Approved
Approval ID
58f45aba-ff6f-43cc-bb88-be40a9f7beda
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 23, 2020
Manufacturers
FDA
Sandoz Inc
DUNS: 005387188
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Digoxin
PRODUCT DETAILS
NDC Product Code0781-3059
Application NumberANDA040481
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, PARENTERAL
Effective DateOctober 9, 2018
Generic NameDigoxin
INGREDIENTS (5)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
DIGOXINActive
Quantity: 250 ug in 1 mL
Code: 73K4184T59
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT