FDA.reportPublic FDA data

inFLIXimab-dyyb 120 MG in 1 ML Prefilled Syringe

RxCUI
2675753
RxNorm name
inFLIXimab-dyyb 120 MG in 1 ML Prefilled Syringe
Display name
inFLIXimab-dyyb 120 MG in 1 ML Prefilled Syringe
Full name
inFLIXimab-dyyb 120 MG in 1 ML Prefilled Syringe
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:08

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761358Zymfentrainfliximab-dyyb351(a)Rx2026-08-01

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZYMFENTRAINFLIXIMAB-DYYBCELLTRION USA Inc.93a193ab-9f96-4da6-aa7c-31212e81879a2025-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2675753

DailyMed RxNorm Mappings#

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

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
93a193ab-9f96-4da6-aa7c-31212e81879ainFLIXimab-dyyb 120 MG in 1 ML Prefilled Syringe [PSN] · 1 ML infliximab-dyyb 120 MG/ML Prefilled Syringe [SCD] · infliximab-dyyb 120 MG per 1 ML Prefilled Syringe [SY]39These highlights do not include all the information needed to use ZYMFENTRA safely and effectively. See full prescribing information for ZYMFENTRA. ZYMFENTRA (infliximab-dyyb) injection, for subcutaneous use Initial U.S. Approval: 201620250528