FDA.reportPublic FDA data

0.4 ML adalimumab-atto 100 MG/ML Prefilled Syringe [Amjevita]

RxCUI
2663907
RxNorm name
0.4 ML adalimumab-atto 100 MG/ML Prefilled Syringe [Amjevita]
Display name
0.4 ML adalimumab-atto 100 MG/ML Prefilled Syringe [Amjevita]
Full name
0.4 ML adalimumab-atto 100 MG/ML Prefilled Syringe [Amjevita]
Term type
SBD
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 · 3 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: 2663907
AMJEVITAADALIMUMAB-ATTOAmgen, Inc9c44bd5b-4464-40a4-8933-8680950f00f22026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2663907
AMJEVITAADALIMUMAB-ATTONuvaila Limitedd7862491-2634-4402-b001-dcc1abf8dd582026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2663907

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
9c44bd5b-4464-40a4-8933-8680950f00f2AMJEVITA 40 MG in 0.4 ML Prefilled Syringe [PSN] · 0.4 ML adalimumab-atto 100 MG/ML Prefilled Syringe [Amjevita] [SBD] · Amjevita 40 MG per 0.4 ML Prefilled Syringe [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-be59bc6a4aa4AMJEVITA 40 MG in 0.4 ML Prefilled Syringe [PSN] · 0.4 ML adalimumab-atto 100 MG/ML Prefilled Syringe [Amjevita] [SBD] · Amjevita 40 MG per 0.4 ML Prefilled Syringe [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
d7862491-2634-4402-b001-dcc1abf8dd58AMJEVITA 40 MG in 0.4 ML Prefilled Syringe [PSN] · 0.4 ML adalimumab-atto 100 MG/ML Prefilled Syringe [Amjevita] [SBD] · Amjevita 40 MG per 0.4 ML Prefilled Syringe [SY]36These 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 b20260308