FDA.reportPublic FDA data

1 ML EPO-epbx 10000 UNT/ML Injection

RxCUI
2047591
RxNorm name
1 ML EPO-epbx 10000 UNT/ML Injection
Display name
1 ML EPO-epbx 10000 UNT/ML Injection
Full name
1 ML EPO-epbx 10000 UNT/ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:54

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125545Retacritepoetin alfa-epbx351(k) BiosimilarRx2026-07-01

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RETACRITEPOETIN ALFA-EPBXVifor (International) Inc.e6e4dd0c-25ca-40b2-ba6b-6138a68621fe2025-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2047591
RETACRITEPOETIN ALFA-EPBXPfizer Laboratories Div Pfizer Inc3af26b0d-8ad0-44e1-a538-8bdb5ab393742025-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2047591

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
3af26b0d-8ad0-44e1-a538-8bdb5ab39374epoetin alfa-epbx 10,000 UNT in 1 ML Injection [PSN] · 1 ML epoetin alfa-epbx 10000 UNT/ML Injection [SCD] · 1 ML EPO-epbx 10000 UNT/ML Injection [SY] · 1 ML ERYTHROPOIETIN-epbx 10000 UNT/ML Injection [SY] · epoetin alfa-epbx 10,000 UNT per 1 ML Injection [SY]519These highlights do not include all the information needed to use RETACRIT safely and effectively. See full prescribing information for RETACRIT. RETACRIT ® (epoetin alfa-epbx) injection, for intravenous or subcutaneous use Initial U.S. Approval: 2018 RETACRIT (epoetin alfa-epbx) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically mean20250622
e6e4dd0c-25ca-40b2-ba6b-6138a68621feepoetin alfa-epbx 10,000 UNT in 1 ML Injection [PSN] · 1 ML epoetin alfa-epbx 10000 UNT/ML Injection [SCD] · 1 ML EPO-epbx 10000 UNT/ML Injection [SY] · 1 ML ERYTHROPOIETIN-epbx 10000 UNT/ML Injection [SY] · epoetin alfa-epbx 10,000 UNT per 1 ML Injection [SY]514These highlights do not include all the information needed to use RETACRIT safely and effectively. See full prescribing information for RETACRIT. RETACRIT ® (epoetin alfa-epbx) injection, for intravenous or subcutaneous use Initial U.S. Approval: 2018 RETACRIT (epoetin alfa-epbx) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically mean20250622