FDA.reportPublic FDA data

Xofigo

Product NDC
50419-208
11-digit product format
504190208
Labeler code
50419
Product ID
50419-208_3d1f78f4-d3bd-4778-a610-7d0827dd66c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Radium Ra 223 dichloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Bayer HealthCare Pharmaceuticals Inc.
Application
NDA203971
Marketing category
NDA
Marketing start
2013-05-20
Substance
RADIUM RA-223 DICHLORIDE
Active strength
30 uCi/mL
Pharmacologic classes
Radioactive alpha-Particle Emitting Therapeutic Agent [EPC], alpha-Particle Emitting Activity [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Xofigo
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RADIUM RA-223 DICHLORIDE30 uCi/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRJ00KV3VTG
Rxcui1424214, 1424219

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
73b7ef70-1c62-4735-8f63-18ac11c2ea54Product name220160502

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50419-208-012024-01-30C16284748780-11030e365-06cd-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use XOFIGO safely and effectively. See full prescribing information for XOFIGO. XOFIGO (radium Ra 223 dichloride) injection, for intravenous use Initial U.S. Approval: 2013

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50419-208-01Xofigo6 mL in 1 VIAL, SINGLE-DOSEINJECTION617

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50419-208-01EA - Each50419-20841fa4ad1-9fa2-4bf0-adbf-ed0f3f3ef2bf12013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RADIUM CHLORIDE RA-223ACTIVE INGREDIENTRJ00KV3VTGXOFIGO (RADIUM RA 223 DICHLORIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]1
RADIUMACTIVE MOIETYW90AYD6R3QXOFIGO (RADIUM RA 223 DICHLORIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBXOFIGO (RADIUM RA 223 DICHLORIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XXOFIGO (RADIUM RA 223 DICHLORIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRXOFIGO (RADIUM RA 223 DICHLORIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RXOFIGO (RADIUM RA 223 DICHLORIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50419-208XOFIGO (RADIUM RA 223 DICHLORIDE) INJECTION [BAYER HEALTHCARE PHARMACEUTICALS INC.]15Current NDC, Legacy NDC, 1 package rows20240704_a398400e-bd31-41a9-9696-4f7c06569ede.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1424214radium Ra-223 1100 kBq/ML in 6 ML InjectionPSNa398400e-bd31-41a9-9696-4f7c06569ede17
1424219Xofigo 1100 kBq/ML in 6 ML InjectionPSNa398400e-bd31-41a9-9696-4f7c06569ede17
14242196 ML radium chloride Ra-223 30 MCI/ML Injection [Xofigo]SBDa398400e-bd31-41a9-9696-4f7c06569ede17
14242146 ML radium chloride Ra-223 30 MCI/ML InjectionSCDa398400e-bd31-41a9-9696-4f7c06569ede17
1424214radium Ra-223 dichloride 178 MCI per 6 ML InjectionSYa398400e-bd31-41a9-9696-4f7c06569ede17
1424214radium Ra-223 dichloride 6600 kBq per 6 ML InjectionSYa398400e-bd31-41a9-9696-4f7c06569ede17
1424219Xofigo (radium Ra-223 dichloride) 6600 kBq per 6 ML InjectionSYa398400e-bd31-41a9-9696-4f7c06569ede17
1424219Xofigo 178 MCI per 6 ML InjectionSYa398400e-bd31-41a9-9696-4f7c06569ede17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50419-208-01504190208016 mL in 1 VIAL, SINGLE-DOSE (50419-208-01) 6 ml2013-05-200000-00-00NoNoCurrent