FDA.reportPublic FDA data

Mircera 0.1 MG per 0.3 ML Prefilled Syringe

RxCUI
1591967
RxNorm name
Mircera 0.1 MG per 0.3 ML Prefilled Syringe
Display name
Mircera 0.1 MG per 0.3 ML Prefilled Syringe
Full name
Mircera 0.1 MG per 0.3 ML Prefilled Syringe
Term type
SY
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)Rx2026-06-01

RxNav Current And Historical NDCs#

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UNII Substances#

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No records found.

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
22c56f2a-f73c-60e7-e054-00144ff88e88Mircera 0.1 MG per 0.3 ML Prefilled SyringeSY9These 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
22c56f2a-f73c-60e7-e054-00144ff88e880.3 ML methoxy polyethylene glycol-epoetin beta 0.333 MG/ML Prefilled Syringe [Mircera]SBD9These 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
22c56f2a-f73c-60e7-e054-00144ff88e88MIRCERA 100 MCG in 0.3 ML Prefilled SyringePSN9These 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
22c56f2a-f73c-60e7-e054-00144ff88e88Mircera 100 MCG per 0.3 ML Prefilled SyringeSY9These 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