FDA.reportPublic FDA data

Oziltus 120 MG per 1.7 ML Injection

RxCUI
2729330
RxNorm name
Oziltus 120 MG per 1.7 ML Injection
Display name
Oziltus 120 MG per 1.7 ML Injection
Full name
Oziltus 120 MG per 1.7 ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:27

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761457Oziltusdenosumab-mobz351(k) InterchangeableRx2026-09-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
f040a245-1be4-4962-a8b7-a13ee7fac707Oziltus 120 MG in 1.7 ML Injection [PSN] · 1.7 ML denosumab-mobz 70 MG/ML Injection [Oziltus] [SBD] · Oziltus 120 MG per 1.7 ML Injection [SY] · Oziltus 70 MG/ML per 1.7 ML Injection [SY]44These highlights do not include all the information needed to use OZILTUS safely and effectively. See full prescribing information for OZILTUS. OZILTUS ® (denosumab-mobz) injection, for subcutaneous use Initial U.S. Approval: 2010 OZILTUS (denosumab-mobz) is biosimilar* to XGEVA ® (denosumab)20251222