1 ML EPO-epbx 4000 UNT/ML Injection

RxCUI: 2047612
RxNorm name: 1 ML EPO-epbx 4000 UNT/ML Injection
Display name: 1 ML EPO-epbx 4000 UNT/ML Injection
Full name: 1 ML EPO-epbx 4000 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
BLA	Proprietary name	Proper name	License type	Status	Latest source
125545	Retacrit	epoetin alfa-epbx	351(k) Biosimilar	Rx	2026-06-01

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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RETACRIT	EPOETIN ALFA-EPBX	Vifor (International) Inc.	e6e4dd0c-25ca-40b2-ba6b-6138a68621fe	2025-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 2047612
RETACRIT	EPOETIN ALFA-EPBX	Pfizer Laboratories Div Pfizer Inc	3af26b0d-8ad0-44e1-a538-8bdb5ab39374	2025-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 2047612

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set ID	RxNorm string	TTY	SPL version	Label	Effective
3af26b0d-8ad0-44e1-a538-8bdb5ab39374	epoetin alfa-epbx 4000 UNT per 1 ML Injection	SY	19	These 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 mean	20250622
3af26b0d-8ad0-44e1-a538-8bdb5ab39374	1 ML ERYTHROPOIETIN-epbx 4000 UNT/ML Injection	SY	19	These 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 mean	20250622
3af26b0d-8ad0-44e1-a538-8bdb5ab39374	epoetin alfa-epbx 4000 UNT in 1 ML Injection	PSN	19	These 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 mean	20250622
3af26b0d-8ad0-44e1-a538-8bdb5ab39374	1 ML epoetin alfa-epbx 4000 UNT/ML Injection	SCD	19	These 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 mean	20250622
3af26b0d-8ad0-44e1-a538-8bdb5ab39374	1 ML EPO-epbx 4000 UNT/ML Injection	SY	19	These 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 mean	20250622
e6e4dd0c-25ca-40b2-ba6b-6138a68621fe	epoetin alfa-epbx 4000 UNT per 1 ML Injection	SY	14	These 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 mean	20250622
e6e4dd0c-25ca-40b2-ba6b-6138a68621fe	1 ML epoetin alfa-epbx 4000 UNT/ML Injection	SCD	14	These 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 mean	20250622
e6e4dd0c-25ca-40b2-ba6b-6138a68621fe	1 ML EPO-epbx 4000 UNT/ML Injection	SY	14	These 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 mean	20250622
e6e4dd0c-25ca-40b2-ba6b-6138a68621fe	epoetin alfa-epbx 4000 UNT in 1 ML Injection	PSN	14	These 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 mean	20250622
e6e4dd0c-25ca-40b2-ba6b-6138a68621fe	1 ML ERYTHROPOIETIN-epbx 4000 UNT/ML Injection	SY	14	These 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 mean	20250622