inFLIXimab-dyyb 100 MG Injection

RxCUI: 1790541
RxNorm name: inFLIXimab-dyyb 100 MG Injection
Display name: inFLIXimab-dyyb 100 MG Injection
Full name: inFLIXimab-dyyb 100 MG Injection
Term type: PSN
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
125544	Inflectra	infliximab-dyyb	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
INFLECTRA	INFLIXIMAB-DYYB	Pfizer Laboratories Div Pfizer Inc	37eaca10-d812-48bc-8b8e-b836bfa9968f	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1790541

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set ID	RxNorm string	TTY	SPL version	Label	Effective
37eaca10-d812-48bc-8b8e-b836bfa9968f	inFLIXimab-dyyb 100 MG Injection	PSN	23	These highlights do not include all the information needed to use INFLECTRA safely and effectively. See full prescribing information for INFLECTRA. INFLECTRA ® (infliximab-dyyb) for injection, for intravenous use Initial U.S. Approval: 2016 INFLECTRA (infliximab-dyyb) 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 meaningful diffe	20250910
37eaca10-d812-48bc-8b8e-b836bfa9968f	infliximab-dyyb 100 MG Injection	SCD	23	These highlights do not include all the information needed to use INFLECTRA safely and effectively. See full prescribing information for INFLECTRA. INFLECTRA ® (infliximab-dyyb) for injection, for intravenous use Initial U.S. Approval: 2016 INFLECTRA (infliximab-dyyb) 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 meaningful diffe	20250910