FDA.reportPublic FDA data

0.3 ML methoxy polyethylene glycol-epoetin beta 0.1 MG/ML Prefilled Syringe [Mircera]

RxCUI
1792485
RxNorm name
0.3 ML methoxy polyethylene glycol-epoetin beta 0.1 MG/ML Prefilled Syringe [Mircera]
Display name
0.3 ML methoxy polyethylene glycol-epoetin beta 0.1 MG/ML Prefilled Syringe [Mircera]
Full name
0.3 ML methoxy polyethylene glycol-epoetin beta 0.1 MG/ML Prefilled Syringe [Mircera]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:50

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125164Mirceramethoxy polyethylene glycol-epoetin beta351(a)Rx2026-09-01

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
MirceraMETHOXY POLYETHYLENE GLYCOL-EPOETIN BETAVifor (International) Inc.22c56f2a-f73c-60e7-e054-00144ff88e882026-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1792485

Reported adverse events (FAERS/openFDA)#

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

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
22c56f2a-f73c-60e7-e054-00144ff88e88MIRCERA 30 MCG in 0.3 ML Prefilled Syringe [PSN] · 0.3 ML methoxy polyethylene glycol-epoetin beta 0.1 MG/ML Prefilled Syringe [Mircera] [SBD] · Mircera 0.03 MG per 0.3 ML Prefilled Syringe [SY] · Mircera 30 MCG per 0.3 ML Prefilled Syringe [SY]49These highlights do not include all the information needed to use MIRCERA safely and effectively. See full prescribing information for MIRCERA. MIRCERA ® (methoxy polyethylene glycol-epoetin beta) injection, for intravenous or subcutaneous use Initial U.S. Approval: 200720240605