FDA.reportPublic FDA data

Hulio 40 MG per 0.8 ML Prefilled Syringe

RxCUI
2640418
RxNorm name
Hulio 40 MG per 0.8 ML Prefilled Syringe
Display name
Hulio 40 MG per 0.8 ML Prefilled Syringe
Full name
Hulio 40 MG per 0.8 ML Prefilled Syringe
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:01

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761154Hulioadalimumab-fkjp351(k) InterchangeableRx2026-07-01

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
HULIOADALIMUMAB-FKJPBiocon Biologics Inc661ad70b-c313-2899-8a7e-7a67bd897ca92025-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2640418

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
661ad70b-c313-2899-8a7e-7a67bd897ca9Hulio 40 MG in 0.8 ML Prefilled Syringe [PSN] · 0.8 ML adalimumab-fkjp 50 MG/ML Prefilled Syringe [Hulio] [SBD] · 0.8 ML Hulio 50 MG/ML Prefilled Syringe [SY] · Hulio 40 MG per 0.8 ML Prefilled Syringe [SY]411These highlights do not include all the information needed to use HULIO safely and effectively. See full prescribing information for HULIO . HULIO ® (adalimumab-fkjp) injection, for subcutaneous use Initial U.S. Approval: 2020 HULIO ® (adalimumab-fkjp) is biosimilar* to HUMIRA (adalimumab)20250206