FDA.reportPublic FDA data

1 ML infliximab-dyyb 120 MG/ML Pen Injector [Zymfentra]

RxCUI
2675749
RxNorm name
1 ML infliximab-dyyb 120 MG/ML Pen Injector [Zymfentra]
Display name
1 ML infliximab-dyyb 120 MG/ML Pen Injector [Zymfentra]
Full name
1 ML infliximab-dyyb 120 MG/ML Pen Injector [Zymfentra]
Term type
SBD
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)Rx2026-06-01

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZYMFENTRAINFLIXIMAB-DYYBCELLTRION USA Inc.93a193ab-9f96-4da6-aa7c-31212e81879a2025-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2675749

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
93a193ab-9f96-4da6-aa7c-31212e81879a1 ML infliximab-dyyb 120 MG/ML Pen Injector [Zymfentra]SBD9These 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
93a193ab-9f96-4da6-aa7c-31212e81879aZymfentra 120 MG in 1 ML Pen InjectorPSN9These 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
93a193ab-9f96-4da6-aa7c-31212e81879aZymfentra 120 MG per 1 ML Pen InjectorSY9These 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
93a193ab-9f96-4da6-aa7c-31212e81879a1 ML Zymfentra 120 MG/ML Pen InjectorSY9These 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