FDA.reportPublic FDA data

0.4 ML darbepoetin alfa 0.025 MG/ML Prefilled Syringe

RxCUI
1605171
RxNorm name
0.4 ML darbepoetin alfa 0.025 MG/ML Prefilled Syringe
Display name
0.4 ML darbepoetin alfa 0.025 MG/ML Prefilled Syringe
Full name
0.4 ML darbepoetin alfa 0.025 MG/ML Prefilled Syringe
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:47

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103951Aranespdarbepoetin alpha351(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
ARANESPDARBEPOETIN ALFAAmgen, Inc0fd36cb9-c4f6-4167-93c9-8530865db3f92026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1605171

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
0fd36cb9-c4f6-4167-93c9-8530865db3f9darbepoetin alfa 10 MCG in 0.4 ML Prefilled Syringe [PSN] · 0.4 ML darbepoetin alfa 0.025 MG/ML Prefilled Syringe [SCD] · darbepoetin alfa 10 MCG per 0.4 ML Prefilled Syringe [SY]3159These highlights do not include all the information needed to use ARANESP safely and effectively. See full prescribing information for ARANESP . ARANESP ® (darbepoetin alfa ) i njection, for intravenous or subcutaneous use Initial U.S. Approval: 200120260308