FDA.reportPublic FDA data

adalimumab-afzb 20 MG per 0.4 ML Prefilled Syringe

RxCUI
2668095
RxNorm name
adalimumab-afzb 20 MG per 0.4 ML Prefilled Syringe
Display name
adalimumab-afzb 20 MG per 0.4 ML Prefilled Syringe
Full name
adalimumab-afzb 20 MG per 0.4 ML Prefilled Syringe
Term type
SY
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#

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
ABRILADAADALIMUMAB-AFZBPfizer Laboratories Div Pfizer Inc5ef1c7cf-466f-495e-8d13-82e2ddfa7a4f2026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2668095

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
5ef1c7cf-466f-495e-8d13-82e2ddfa7a4fadalimumab-afzb 20 MG per 0.4 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 20 MG in 0.4 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 0.4 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-8d13-82e2ddfa7a4f0.4 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