| Product NDC: | 50419-208 |
| Proprietary Name: | Xofigo |
| Non Proprietary Name: | Radium Ra 223 dichloride |
| Active Ingredient(s): | 27 uCi/mL & nbsp; Radium Ra 223 dichloride |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 50419-208 |
| Labeler Name: | Bayer HealthCare Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA203971 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20130520 |
| Package NDC: | 50419-208-01 |
| Package Description: | 6 mL in 1 VIAL, SINGLE-DOSE (50419-208-01) |
| NDC Code | 50419-208-01 |
| Proprietary Name | Xofigo |
| Package Description | 6 mL in 1 VIAL, SINGLE-DOSE (50419-208-01) |
| Product NDC | 50419-208 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Radium Ra 223 dichloride |
| Dosage Form Name | INJECTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20130520 |
| Marketing Category Name | NDA |
| Labeler Name | Bayer HealthCare Pharmaceuticals Inc. |
| Substance Name | RADIUM CHLORIDE RA-223 |
| Strength Number | 27 |
| Strength Unit | uCi/mL |
| Pharmaceutical Classes |