FDA.reportPublic FDA data

Prolia 60 MG per 1 ML Prefilled Syringe

RxCUI
993456
RxNorm name
Prolia 60 MG per 1 ML Prefilled Syringe
Display name
Prolia 60 MG per 1 ML Prefilled Syringe
Full name
Prolia 60 MG per 1 ML Prefilled Syringe
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:56

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125320Proliadenosumab351(a)Rx2026-07-01

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.

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProliaDENOSUMABAmgen, Inc49e5afe9-a0c7-40c4-af9f-f287a80c5c882026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993456

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
49e5afe9-a0c7-40c4-af9f-f287a80c5c88Prolia 60 MG in 1 ML Prefilled Syringe [PSN] · 1 ML denosumab 60 MG/ML Prefilled Syringe [Prolia] [SBD] · 1 ML Prolia 60 MG/ML Prefilled Syringe [SY] · Prolia 60 MG per 1 ML Prefilled Syringe [SY]4185These highlights do not include all the information needed to use PROLIA safely and effectively. See full prescribing information for PROLIA. PROLIA ® (denosumab) injection, for subcutaneous use Initial U.S. Approval: 201020260310