FDA.reportPublic FDA data

0.3 ML methoxy polyethylene glycol-epoetin beta 0.4 MG/ML Prefilled Syringe [Mircera]

RxCUI
1792490
RxNorm name
0.3 ML methoxy polyethylene glycol-epoetin beta 0.4 MG/ML Prefilled Syringe [Mircera]
Display name
0.3 ML methoxy polyethylene glycol-epoetin beta 0.4 MG/ML Prefilled Syringe [Mircera]
Full name
0.3 ML methoxy polyethylene glycol-epoetin beta 0.4 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)Rx2026-06-01

RxNav Current And Historical NDCs#

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UNII Substances#

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DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
22c56f2a-f73c-60e7-e054-00144ff88e880.3 ML methoxy polyethylene glycol-epoetin beta 0.4 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 120 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
22c56f2a-f73c-60e7-e054-00144ff88e88Mircera 0.12 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-e054-00144ff88e88MIRCERA 120 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