methoxy polyethylene glycol-epoetin beta 75 MCG per 0.3 ML Prefilled Syringe
- RxCUI
- 804171
- RxNorm name
- methoxy polyethylene glycol-epoetin beta 75 MCG per 0.3 ML Prefilled Syringe
- Display name
- methoxy polyethylene glycol-epoetin beta 75 MCG per 0.3 ML Prefilled Syringe
- Full name
- methoxy polyethylene glycol-epoetin beta 75 MCG 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 | License type | Status | Latest source |
|---|---|---|---|---|---|
| 125164 | Mircera | methoxy polyethylene glycol-epoetin beta | 351(a) | Rx | 2026-09-01 |
UNII Substances#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Mircera | METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA | Vifor (International) Inc. | 22c56f2a-f73c-60e7-e054-00144ff88e88 | 2026-08-14 | Boxed warning, Warnings, Adverse reactions | 804171 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed RxNorm Mappings#
| Set ID | RxNorm mappings | Terms | SPL version | Label | Effective |
|---|---|---|---|---|---|
| 22c56f2a-f73c-60e7-e054-00144ff88e88 | methoxy polyethylene glycol-epoetin beta 75 MCG in 0.3 ML Prefilled Syringe [PSN] · 0.3 ML methoxy polyethylene glycol-epoetin beta 0.25 MG/ML Prefilled Syringe [SCD] · methoxy polyethylene glycol-epoetin beta 0.075 MG per 0.3 ML Prefilled Syringe [SY] · methoxy polyethylene glycol-epoetin beta 75 MCG per 0.3 ML Prefilled Syringe [SY] | 4 | 9 | These 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: 2007 | 20240605 |