FDA.reportPublic FDA data

{4 (0.8 ML adalimumab-aacf 50 MG/ML Auto-Injector [Idacio]) } Pack [Idacio Pen 40 MG/0.8 ML Starter Pack - Plaque Psoriasis]

RxCUI
2640865
RxNorm name
{4 (0.8 ML adalimumab-aacf 50 MG/ML Auto-Injector [Idacio]) } Pack [Idacio Pen 40 MG/0.8 ML Starter Pack - Plaque Psoriasis]
Display name
{4 (0.8 ML adalimumab-aacf 50 MG/ML Auto-Injector [Idacio]) } Pack [Idacio Pen 40 MG/0.8 ML Starter Pack - Plaque Psoriasis]
Full name
{4 (0.8 ML adalimumab-aacf 50 MG/ML Auto-Injector [Idacio]) } Pack [Idacio Pen 40 MG/0.8 ML Starter Pack - Plaque Psoriasis]
Term type
BPCK
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: 2640865

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
43de75ac-1a37-4609-9edd-68bda2448a47{4 (0.8 ML adalimumab-aacf 50 MG/ML Auto-Injector [Idacio]) } Pack [Idacio Pen 40 MG/0.8 ML Starter Pack - Plaque Psoriasis]BPCK7These 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 Pen 40 MG/0.8 ML Starter Pack - Plaque Psoriasis (4 count)PSN7These 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 Pen 40 MG/0.8 ML Starter Pack - Plaque Psoriasis (4 count)SY7These 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