xofigo

Generic: radium ra 223 dichloride

Labeler: bayer healthcare pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xofigo
Generic Name radium ra 223 dichloride
Labeler bayer healthcare pharmaceuticals inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

radium ra-223 dichloride 30 uCi/mL

Manufacturer
Bayer HealthCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 50419-208
Product ID 50419-208_3d1f78f4-d3bd-4778-a610-7d0827dd66c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203971
Listing Expiration 2027-12-31
Marketing Start 2013-05-20

Pharmacologic Class

Classes
radioactive alpha-particle emitting therapeutic agent [epc] alpha-particle emitting activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50419208
Hyphenated Format 50419-208

Supplemental Identifiers

RxCUI
1424214 1424219
UNII
RJ00KV3VTG

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name xofigo (source: ndc)
Generic Name radium ra 223 dichloride (source: ndc)
Application Number NDA203971 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 30 uCi/mL
source: ndc
Packaging
  • 6 mL in 1 VIAL, SINGLE-DOSE (50419-208-01)
source: ndc

Packages (1)

50419-208-01 6 mL in 1 VIAL, SINGLE-DOSE (50419-208-01)

Ingredients (1)

radium ra-223 dichloride (30 uCi/mL)

Linked Drug Pages (1)

Xofigo ndc-match (0.9)

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"}