FDA.reportPublic FDA data

AMJEVITA 80 MG in 0.8 ML Auto-Injector

RxCUI
2663915
RxNorm name
AMJEVITA 80 MG in 0.8 ML Auto-Injector
Display name
AMJEVITA 80 MG in 0.8 ML Auto-Injector
Full name
AMJEVITA 80 MG in 0.8 ML Auto-Injector
Term type
PSN
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: 2663915
AMJEVITAADALIMUMAB-ATTOAmgen, Inc9c44bd5b-4464-40a4-8933-8680950f00f22026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2663915
AMJEVITAADALIMUMAB-ATTONuvaila Limitedd7862491-2634-4402-b001-dcc1abf8dd582026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2663915

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 80 MG in 0.8 ML Auto-Injector [PSN] · 0.8 ML adalimumab-atto 100 MG/ML Auto-Injector [Amjevita] [SBD] · Amjevita 80 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-be59bc6a4aa4AMJEVITA 80 MG in 0.8 ML Auto-Injector [PSN] · 0.8 ML adalimumab-atto 100 MG/ML Auto-Injector [Amjevita] [SBD] · Amjevita 80 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
d7862491-2634-4402-b001-dcc1abf8dd58AMJEVITA 80 MG in 0.8 ML Auto-Injector [PSN] · 0.8 ML adalimumab-atto 100 MG/ML Auto-Injector [Amjevita] [SBD] · Amjevita 80 MG per 0.8 ML Auto-Injector [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