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United States · US · US:50419-208_3d1f78f4-d3bd-4778-a610-7d0827dd66c4
Xofigo
Orange BookUNIISPLATC V10XX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBayer HealthCare Pharmaceuticals Inc.
CountryUS (United States)
ATC codeV10XX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1150419208016 mL in 1 VIAL, SINGLE-DOSE (50419-208-01)
Annotations
UNII (FDA Substance ID)
RJ00KV3VTG
RADIUM RA-223 DICHLORIDE
RxCUI 1424174
Orange Book
N203971
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "RJ00KV3VTG",
"rxcui": "1424174",
"inchikey": "RWRDJVNMSZYMDV-SIUYXFDKSA-L",
"display_name": "RADIUM RA-223 DICHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"a398400e-bd31-41a9-9696-4f7c06569ede": {
"match": "brand_token",
"title": "XOFIGO (RADIUM RA 223 DICHLORIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]",
"spl_version": "17",
"published_date": "2026-03-04"
}
},
"productid": "50419-208_3d1f78f4-d3bd-4778-a610-7d0827dd66c4",
"productndc": "50419-208",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "203971",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "162mCi/6ML (27mCi/ML)",
"product_no": "001",
"approval_date": "May 15, 2013"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RADIUM RA-223 DICHLORIDE",
"proprietary_name": "Xofigo",
"active_ingred_unit": "uCi/mL",
"application_number": "NDA203971",
"marketing_category": "NDA",
"nonproprietary_name": "Radium Ra 223 dichloride",
"start_marketing_date": "20130520",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code V10XX03.
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