FDA.reportPublic FDA data

{4 (0.8 ML adalimumab-aacf 50 MG/ML Auto-Injector) } Pack

RxCUI
2640864
RxNorm name
{4 (0.8 ML adalimumab-aacf 50 MG/ML Auto-Injector) } Pack
Display name
{4 (0.8 ML adalimumab-aacf 50 MG/ML Auto-Injector) } Pack
Full name
{4 (0.8 ML adalimumab-aacf 50 MG/ML Auto-Injector) } Pack
Term type
GPCK
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 · 2 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: 2640864
Adalimumab-aacfADALIMUMABFresenius Kabi USA, LLC2488b0bc-7b8f-4cc8-91ea-48e7ea5e89152026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2640864

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
43de75ac-1a37-4609-9edd-68bda2448a47adalimumab-aacf starter pack 40 MG/0.8 ML Auto-Injector (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
43de75ac-1a37-4609-9edd-68bda2448a47adalimumab-aacf starter pack 40 MG/0.8 ML Auto-Injector (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-68bda2448a47{4 (0.8 ML adalimumab-aacf 50 MG/ML Auto-Injector) } PackGPCK7These 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
2488b0bc-7b8f-4cc8-91ea-48e7ea5e8915adalimumab-aacf starter pack 40 MG/0.8 ML Auto-Injector (4 count)SY6These highlights do not include all the information needed to use ADALIMUMAB-AACF safely and effectively. See full prescribing information for ADALIMUMAB-AACF. ADALIMUMAB-AACF injection, for subcutaneous use Initial U.S. Approval: 2022 This product is IDACIO ® (adalimumab-aacf). 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 th20260108
2488b0bc-7b8f-4cc8-91ea-48e7ea5e8915{4 (0.8 ML adalimumab-aacf 50 MG/ML Auto-Injector) } PackGPCK6These highlights do not include all the information needed to use ADALIMUMAB-AACF safely and effectively. See full prescribing information for ADALIMUMAB-AACF. ADALIMUMAB-AACF injection, for subcutaneous use Initial U.S. Approval: 2022 This product is IDACIO ® (adalimumab-aacf). 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 th20260108
2488b0bc-7b8f-4cc8-91ea-48e7ea5e8915adalimumab-aacf starter pack 40 MG/0.8 ML Auto-Injector (4 count)PSN6These highlights do not include all the information needed to use ADALIMUMAB-AACF safely and effectively. See full prescribing information for ADALIMUMAB-AACF. ADALIMUMAB-AACF injection, for subcutaneous use Initial U.S. Approval: 2022 This product is IDACIO ® (adalimumab-aacf). 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 th20260108