FDA.reportPublic FDA data

0.8 ML Idacio 50 MG/ML Prefilled Syringe

RxCUI
2640857
RxNorm name
0.8 ML Idacio 50 MG/ML Prefilled Syringe
Display name
0.8 ML Idacio 50 MG/ML Prefilled Syringe
Full name
0.8 ML Idacio 50 MG/ML Prefilled Syringe
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:56

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761255Idacioadalimumab-aacf351(k) BiosimilarRx2026-06-01

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#

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
IdacioADALIMUMAB-AACFFresenius Kabi USA, LLC43de75ac-1a37-4609-9edd-68bda2448a472026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2640857

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
43de75ac-1a37-4609-9edd-68bda2448a470.8 ML Idacio 50 MG/ML Prefilled SyringeSY7These highlights do not include all the information needed to use IDACIO safely and effectively. See full prescribing information for IDACIO. IDACIO® (adalimumab-aacf) injection, for subcutaneous use Initial U.S. Approval: 2022 IDACIO® (adalimumab-aacf) 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 differences between 20260130
43de75ac-1a37-4609-9edd-68bda2448a47Idacio 40 MG in 0.8 ML Prefilled SyringePSN7These highlights do not include all the information needed to use IDACIO safely and effectively. See full prescribing information for IDACIO. IDACIO® (adalimumab-aacf) injection, for subcutaneous use Initial U.S. Approval: 2022 IDACIO® (adalimumab-aacf) 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 differences between 20260130
43de75ac-1a37-4609-9edd-68bda2448a47Idacio 40 MG per 0.8 ML Prefilled SyringeSY7These highlights do not include all the information needed to use IDACIO safely and effectively. See full prescribing information for IDACIO. IDACIO® (adalimumab-aacf) injection, for subcutaneous use Initial U.S. Approval: 2022 IDACIO® (adalimumab-aacf) 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 differences between 20260130
43de75ac-1a37-4609-9edd-68bda2448a470.8 ML adalimumab-aacf 50 MG/ML Prefilled Syringe [Idacio]SBD7These highlights do not include all the information needed to use IDACIO safely and effectively. See full prescribing information for IDACIO. IDACIO® (adalimumab-aacf) injection, for subcutaneous use Initial U.S. Approval: 2022 IDACIO® (adalimumab-aacf) 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 differences between 20260130