Package 50419-208-01
Brand: xofigo
Generic: radium ra 223 dichloridePackage Facts
Identity
Package NDC
50419-208-01
Digits Only
5041920801
Product NDC
50419-208
Description
6 mL in 1 VIAL, SINGLE-DOSE (50419-208-01)
Marketing
Marketing Status
Brand
xofigo
Generic
radium ra 223 dichloride
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "3d1f78f4-d3bd-4778-a610-7d0827dd66c4", "openfda": {"unii": ["RJ00KV3VTG"], "rxcui": ["1424214", "1424219"], "spl_set_id": ["a398400e-bd31-41a9-9696-4f7c06569ede"], "manufacturer_name": ["Bayer HealthCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 mL in 1 VIAL, SINGLE-DOSE (50419-208-01)", "package_ndc": "50419-208-01", "marketing_start_date": "20130520"}], "brand_name": "Xofigo", "product_id": "50419-208_3d1f78f4-d3bd-4778-a610-7d0827dd66c4", "dosage_form": "INJECTION", "pharm_class": ["Radioactive alpha-Particle Emitting Therapeutic Agent [EPC]", "alpha-Particle Emitting Activity [MoA]"], "product_ndc": "50419-208", "generic_name": "Radium Ra 223 dichloride", "labeler_name": "Bayer HealthCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Xofigo", "active_ingredients": [{"name": "RADIUM RA-223 DICHLORIDE", "strength": "30 uCi/mL"}], "application_number": "NDA203971", "marketing_category": "NDA", "marketing_start_date": "20130520", "listing_expiration_date": "20271231"}