FDA.reportPublic FDA data

adalimumab-atto 40 MG per 0.8 ML Auto-Injector

RxCUI
2627719
RxNorm name
adalimumab-atto 40 MG per 0.8 ML Auto-Injector
Display name
adalimumab-atto 40 MG per 0.8 ML Auto-Injector
Full name
adalimumab-atto 40 MG per 0.8 ML Auto-Injector
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:10

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761024Amjevitaadalimumab-atto351(k) InterchangeableRx2026-07-01

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
AMJEVITAADALIMUMAB-ATTOAmgen USA Inc.b7178e36-6787-45ab-8fee-be59bc6a4aa42026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2627719
AMJEVITAADALIMUMAB-ATTOAmgen, Inc9c44bd5b-4464-40a4-8933-8680950f00f22026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2627719

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
9c44bd5b-4464-40a4-8933-8680950f00f2adalimumab-atto 40 MG in 0.8 ML Auto-Injector [PSN] · 0.8 ML adalimumab-atto 50 MG/ML Auto-Injector [SCD] · adalimumab-atto 40 MG per 0.8 ML Auto-Injector [SY]335These highlights do not include all the information needed to use AMJEVITA safely and effectively. See full prescribing information for AMJEVITA. AMJEVITA ® (adalimumab-atto) injection, for subcutaneous use Initial U.S. Approval: 2016 AMJEVITA (adalimumab-atto) 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 b20260310
b7178e36-6787-45ab-8fee-be59bc6a4aa4adalimumab-atto 40 MG in 0.8 ML Auto-Injector [PSN] · 0.8 ML adalimumab-atto 50 MG/ML Auto-Injector [SCD] · adalimumab-atto 40 MG per 0.8 ML Auto-Injector [SY]314These highlights do not include all the information needed to use AMJEVITA safely and effectively. See full prescribing information for AMJEVITA. AMJEVITA ® (adalimumab-atto) injection, for subcutaneous use Initial U.S. Approval: 2016 AMJEVITA (adalimumab-atto) 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 b20251021