FDA.reportPublic FDA data

adalimumab-afzb 40 MG in 0.8 ML Prefilled Syringe

RxCUI
2668074
RxNorm name
adalimumab-afzb 40 MG in 0.8 ML Prefilled Syringe
Display name
adalimumab-afzb 40 MG in 0.8 ML Prefilled Syringe
Full name
adalimumab-afzb 40 MG in 0.8 ML Prefilled Syringe
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:00

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761118Abriladaadalimumab-afzb351(k) InterchangeableRx2026-06-01

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
ABRILADAADALIMUMAB-AFZBPfizer Laboratories Div Pfizer Inc5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f2026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2668074

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
5ef1c7cf-466f-495e-8d13-82e2ddfa7a4fadalimumab-afzb 40 MG in 0.8 ML Prefilled SyringePSN8These highlights do not include all the information needed to use ABRILADA safely and effectively. See full prescribing information for ABRILADA. ABRILADA™ (adalimumab-afzb) injection, for subcutaneous use Initial U.S. Approval: 2019 ABRILADA (adalimumab-afzb) 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 b20260506
5ef1c7cf-466f-495e-8d13-82e2ddfa7a4fadalimumab-afzb 50 MG/ML per 0.8 ML Prefilled SyringeSY8These highlights do not include all the information needed to use ABRILADA safely and effectively. See full prescribing information for ABRILADA. ABRILADA™ (adalimumab-afzb) injection, for subcutaneous use Initial U.S. Approval: 2019 ABRILADA (adalimumab-afzb) 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 b20260506
5ef1c7cf-466f-495e-8d13-82e2ddfa7a4fadalimumab-afzb 40 MG per 0.8 ML Prefilled SyringeSY8These highlights do not include all the information needed to use ABRILADA safely and effectively. See full prescribing information for ABRILADA. ABRILADA™ (adalimumab-afzb) injection, for subcutaneous use Initial U.S. Approval: 2019 ABRILADA (adalimumab-afzb) 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 b20260506
5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f0.8 ML adalimumab-afzb 50 MG/ML Prefilled SyringeSCD8These highlights do not include all the information needed to use ABRILADA safely and effectively. See full prescribing information for ABRILADA. ABRILADA™ (adalimumab-afzb) injection, for subcutaneous use Initial U.S. Approval: 2019 ABRILADA (adalimumab-afzb) 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 b20260506