FDA.reportPublic FDA data

1 ML evolocumab 140 MG/ML Prefilled Syringe

RxCUI
1665904
RxNorm name
1 ML evolocumab 140 MG/ML Prefilled Syringe
Display name
1 ML evolocumab 140 MG/ML Prefilled Syringe
Full name
1 ML evolocumab 140 MG/ML Prefilled Syringe
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:21

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125522Repathaevolocumab351(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
REPATHAEVOLOCUMABAmgen USA Inc.cd61e902-166d-4aa6-9f3c-a18c1008d07e2026-07-16Warnings, Adverse reactionsExact identifier
rxcui: 1665904

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
cd61e902-166d-4aa6-9f3c-a18c1008d07e1 ML evolocumab 140 MG/ML Prefilled SyringeSCD27These highlights do not include all the information needed to use REPATHA ® safely and effectively. See full prescribing information for REPATHA. REPATHA (evolocumab) injection, for subcutaneous use Initial U.S. Approval: 201520260122
cd61e902-166d-4aa6-9f3c-a18c1008d07eevolocumab 140 MG in 1 ML Prefilled SyringePSN27These highlights do not include all the information needed to use REPATHA ® safely and effectively. See full prescribing information for REPATHA. REPATHA (evolocumab) injection, for subcutaneous use Initial U.S. Approval: 201520260122