Xofigo
These highlights do not include all the information needed to use XOFIGO safely and effectively. See full prescribing information for XOFIGO. XOFIGO (radium Ra 223 dichloride) injection, for intravenous useInitial U.S. Approval: 2013
Approved
Approval ID
a398400e-bd31-41a9-9696-4f7c06569ede
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 10, 2019
Manufacturers
FDA
Bayer HealthCare Pharmaceuticals Inc.
DUNS: 005436809
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Radium Ra 223 dichloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50419-208
Application NumberNDA203971
Product Classification
M
Marketing Category
C73594
G
Generic Name
Radium Ra 223 dichloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 24, 2017
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
RADIUM RA-223 DICHLORIDEActive
Quantity: 30 uCi in 1 mL
Code: RJ00KV3VTG
Classification: ACTIB
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT