NDC 50419-208

Xofigo

Radium Ra 223 Dichloride

Xofigo is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Bayer Healthcare Pharmaceuticals Inc.. The primary component is Radium Ra-223 Dichloride.

• Product ID: 50419-208_1c6daf0f-a7c7-46ea-aaf6-31b4c30b6679
• NDC: 50419-208
• Product Type: Human Prescription Drug
• Proprietary Name: Xofigo
• Generic Name: Radium Ra 223 Dichloride
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2013-05-20
• Marketing Category: NDA / NDA
• Application Number: NDA203971
• Labeler Name: Bayer HealthCare Pharmaceuticals Inc.
• Substance Name: RADIUM RA-223 DICHLORIDE
• Active Ingredient Strength: 30 uCi/mL
• Pharm Classes: Radioactive alpha-Particle Emitting Therapeutic Agent [EPC], alpha-Particle Emitting Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 50419-208-01

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

• Marketing Start Date: 2013-05-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50419-208-01 [50419020801]

Xofigo INJECTION

• Marketing Category: NDA
• Application Number: NDA203971
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-05-20

Drug Details

Active Ingredients

Ingredient	Strength
RADIUM RA-223 DICHLORIDE	30 uCi/mL

OpenFDA Data

• SPL SET ID: a398400e-bd31-41a9-9696-4f7c06569ede
• Manufacturer:
  • Bayer HealthCare Pharmaceuticals Inc.
• UNII:
  • RJ00KV3VTG
• RxNorm Concept Unique ID - RxCUI:
  • 1424219
  • 1424214

Pharmacological Class

• Radioactive alpha-Particle Emitting Therapeutic Agent [EPC]
• alpha-Particle Emitting Activity [MoA]