FDA.reportPublic FDA data

DENOSUMAB - Food and Drug Administration

Manufacturer
Food and Drug Administration
Effective date
2018-04-23
Label type
Indexing - product concept
Version
1
Source
full-release
Hydrated at
2026-06-05 00:17:33

Label at a glance#

ProductDENOSUMAB
Active ingredientDENOSUMAB

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
DENOSUMAB4EQZ6YO2HIACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BILDYOSDENOSUMABOrganon LLCb9e32bf7-d70a-4083-8577-c15751c7f7692026-08-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DENOSUMAB
BilprevdaDENOSUMABOrganon LLCb1f0590e-f5bb-44ac-99a0-4aa4596c7e542026-08-18Warnings, Adverse reactionsName fallback
generic name: DENOSUMAB
ProliaDENOSUMABAmgen, Inc49e5afe9-a0c7-40c4-af9f-f287a80c5c882026-06-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DENOSUMAB
XGEVADENOSUMABAmgen, Inc628f0998-1206-4001-aeee-18133aa9f3bf2026-06-23Warnings, Adverse reactionsName fallback
generic name: DENOSUMAB
WYOSTDENOSUMABSandoz Inc69e4890d-5dd9-42a5-aa41-ce50635eaed72026-02-20Warnings, Adverse reactionsName fallback
generic name: DENOSUMAB
CONEXXENCEDENOSUMABFresenius Kabi USA, LLC39a0a789-778f-4695-b3a9-61643e6396cd2025-12-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DENOSUMAB
OSPOMYVDENOSUMABCordavis Limitede1d80a82-de52-4a34-9df3-609e50667ffb2025-11-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DENOSUMAB
JUBBONTIDENOSUMABSandoz Inc4bf239bb-c467-4add-b7cf-ea666e4fc6932025-10-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DENOSUMAB
BOMYNTRADENOSUMABFresenius Kabi USA, LLC49d25732-e05d-47e4-98cb-67df04796d4b2025-03-31Warnings, Adverse reactionsName fallback
generic name: DENOSUMAB

Reported adverse events (FAERS/openFDA)#

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