Prescription drug · NDA
Xofigo (Radium ra 223 dichloride) NDC 50419-208
Radium ra-223 dichloride 30 uCi/mL · Injection · Intravenous · Bayer HealthCare Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50419-208-01 | 50419020801 | 6 mL in 1 VIAL, SINGLE-DOSE (50419-208-01)Marketed from May 20, 2013 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Xofigo
- Generic name (nonproprietary)
- radium ra 223 dichloride
- Active ingredients
- Radium ra-223 dichloride — 30 uCi/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Bayer HealthCare Pharmaceuticals Inc.NDC labeler code 50419
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 203971
- Marketing start
- Listing expires
- Other FDA classes
- alpha-Particle Emitting Activity (Mechanism)
- Identifiers
- Product ID 50419-208_3d1f78f4-d3bd-4778-a610-7d0827dd66c4SPL ID 3d1f78f4-d3bd-4778-a610-7d0827dd66c4SPL set ID a398400e-bd31-41a9-9696-4f7c06569edeRxCUI 1424214, 1424219UNII RJ00KV3VTG
- Pharmacologic class
- Radioactive alpha-Particle Emitting Therapeutic Agent
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N450419020801followed by a unit qualifier and the quantityPackage 50419-0208-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigo is an alpha particle-emitting radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 50419-208
- What is NDC 50419-208?
- 50419-208 is the product NDC for Xofigo (radium ra 223 dichloride), Radium ra-223 dichloride 30 uCi/mL injection, listed with the FDA by Bayer HealthCare Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xofigo (Radium Ra 223 dichloride).
- What is the active ingredient?
- Radium ra-223 dichloride.
- Who is the labeler?
- Bayer HealthCare Pharmaceuticals Inc., NDC labeler code 50419. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Xofigo?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.