epcoritamab-bysp 48 MG per 0.8 ML Injection

RxCUI: 2637399
RxNorm name: epcoritamab-bysp 48 MG per 0.8 ML Injection
Display name: epcoritamab-bysp 48 MG per 0.8 ML Injection
Full name: epcoritamab-bysp 48 MG per 0.8 ML Injection
Term type: SY
Status: DailyMed mapping
Updated: 2026-06-04 23:39:23

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761324	Epkinly	epcoritamab-bysp	351(a)	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EPKINLY	EPCORITAMAB-BYSP	Genmab US, Inc.	d7836711-b677-412d-bf2d-0f7c8444103a	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 2637399

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set ID	RxNorm string	TTY	SPL version	Label	Effective
d7836711-b677-412d-bf2d-0f7c8444103a	epcoritamab-bysp 48 MG per 0.8 ML Injection	SY	10	These highlights do not include all the information needed to use EPKINLY safely and effectively. See full prescribing information for EPKINLY. EPKINLY ® (epcoritamab-bysp) injection, for subcutaneous use Initial U.S. Approval: 2023	20260401
d7836711-b677-412d-bf2d-0f7c8444103a	0.8 ML epcoritamab-bysp 60 MG/ML Injection	SCD	10	These highlights do not include all the information needed to use EPKINLY safely and effectively. See full prescribing information for EPKINLY. EPKINLY ® (epcoritamab-bysp) injection, for subcutaneous use Initial U.S. Approval: 2023	20260401
d7836711-b677-412d-bf2d-0f7c8444103a	epcoritamab-bysp 48 MG in 0.8 ML Injection	PSN	10	These highlights do not include all the information needed to use EPKINLY safely and effectively. See full prescribing information for EPKINLY. EPKINLY ® (epcoritamab-bysp) injection, for subcutaneous use Initial U.S. Approval: 2023	20260401