FDA.reportPublic FDA data

1 ML denosumab-qbde 60 MG/ML Prefilled Syringe

RxCUI
2725566
RxNorm name
1 ML denosumab-qbde 60 MG/ML Prefilled Syringe
Display name
1 ML denosumab-qbde 60 MG/ML Prefilled Syringe
Full name
1 ML denosumab-qbde 60 MG/ML Prefilled Syringe
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:06

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761439Enobydenosumab-qbde351(k) InterchangeableRx2026-07-01

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
ENOBYDENOSUMAB-QBDEHikma Pharmaceuticals USA Inc.815d3ba4-27a1-4a06-925a-a87f35442bdb2026-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2725566

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
815d3ba4-27a1-4a06-925a-a87f35442bdbdenosumab-qbde 60 MG in 1 ML Prefilled Syringe [PSN] · 1 ML denosumab-qbde 60 MG/ML Prefilled Syringe [SCD] · denosumab-qbde 60 MG per 1 ML Prefilled Syringe [SY]35These highlights do not include all the information needed to use ENOBY™ safely and effectively. See full prescribing information for ENOBY. ENOBY™ (denosumab-qbde) injection, for subcutaneous use Initial U.S. Approval: 2025 ENOBY™ (denosumab-qbde) is biosimilar* to PROLIA ® (denosumab).20260116