givers.
•
Who are sexually active to use condoms and their female partners of reproductive potential to use a highly effective method of birth control during treatment and for 6 months following completion of Xofigo treatment.
Manufactured for:
Bayer HealthCare Pharmaceuticals Inc.
Wayne, NJ 07470
Manufactured in Norway
Xofigo is a trademark of Bayer Aktiengesellschaft.
© 2013, Bayer HealthCare Pharmaceuticals Inc.
All rights reserved.
Revised: 05/2013
NDC 50419-208-01
6 mL
Xofigo™
Radium Ra 223 dichloride injection
1000 kBq/mL (27 microcurie/mL)
For Intravenous Administration
Sterile
Single-Dose Vial:
Discard Unused Portion
Manufactured for:
Bayer HealthCare
Wayne, NJ 07470
Manufactured in Norway
6000 kBq/vial (162 microcurie/vial) at 5AM CST 912 noon CET) on reference date:
LOT:
EXP:
XOFIGO
radium ra 223 dichloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50419-208
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RADIUM CHLORIDE RA-223 (RADIUM) RADIUM CHLORIDE RA-223 27 uCi in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM CITRATE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description
1 NDC:50419-208-01 6 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203971 05/20/2013
Labeler - Bayer HealthCare Pharmaceuticals Inc. (005436809)
Registrant - Bayer HealthCare Pharmaceuticals Inc. (005436809)
Establishment
Name Address ID/FEI Business Operations
Institutt For Energiteknikk 518771688 MANUFACTURE(50419-208), LABEL(50419-208)
Revised: 05/2013
Document Id: a398400e-bd31-41a9-9696-4f7c06569ede
Set id: a398400e-bd31-41a9-9696-4f7c06569ede
Version: 1
