FDA.reportPublic FDA data

Idacio 40 MG in 0.8 ML Injection

RxCUI
2699319
RxNorm name
Idacio 40 MG in 0.8 ML Injection
Display name
Idacio 40 MG in 0.8 ML Injection
Full name
Idacio 40 MG in 0.8 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:46

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#

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
IDACIOADALIMUMAB-AACFFresenius Kabi USA, LLC08dbaffe-9d05-43cf-b24b-b44ade8685fc2024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2699319

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
08dbaffe-9d05-43cf-b24b-b44ade8685fcIdacio 40 MG in 0.8 ML InjectionPSN1These 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 Initial U.S. Approval: 2022 IDACIO® (adalimumab-aacf) is biosimilar Guide: 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 20241015
08dbaffe-9d05-43cf-b24b-b44ade8685fc0.8 ML adalimumab-aacf 50 MG/ML Injection [Idacio]SBD1These 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 Initial U.S. Approval: 2022 IDACIO® (adalimumab-aacf) is biosimilar Guide: 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 20241015
08dbaffe-9d05-43cf-b24b-b44ade8685fcIdacio 40 MG per 0.8 ML InjectionSY1These 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 Initial U.S. Approval: 2022 IDACIO® (adalimumab-aacf) is biosimilar Guide: 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 20241015