FDA.reportPublic FDA data

0.8 ML adalimumab-adbm 50 MG/ML Auto-Injector

RxCUI
2640895
RxNorm name
0.8 ML adalimumab-adbm 50 MG/ML Auto-Injector
Display name
0.8 ML adalimumab-adbm 50 MG/ML Auto-Injector
Full name
0.8 ML adalimumab-adbm 50 MG/ML Auto-Injector
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:47

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761058Cyltezoadalimumab-adbm351(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
CyltezoADALIMUMAB-ADBMBoehringer Ingelheim Pharmaceuticals, Inc.115ea79b-7209-7f19-b35d-36ec0828fbf52026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2640895
Adalimumab-adbmADALIMUMAB-ADBMBoehringer Ingelheim Pharmaceuticals, Inc.62f39a7c-00df-4519-a8d4-39bbd0a649ed2025-11-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2640895
Adalimumab-adbmADALIMUMAB-ADBMQUALLENT PHARMACEUTICALS HEALTH LLCf9986706-9c75-4335-a54f-09d7716dbcef2024-11-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2640895

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
115ea79b-7209-7f19-b35d-36ec0828fbf5adalimumab-adbm 40 MG in 0.8 ML Auto-Injector [PSN] · 0.8 ML adalimumab-adbm 50 MG/ML Auto-Injector [SCD] · adalimumab-adbm 40 MG per 0.8 ML Auto-Injector [SY]317These highlights do not include all the information needed to use CYLTEZO safely and effectively. See full prescribing information for CYLTEZO. CYLTEZO ® (adalimumab-adbm) injection, for subcutaneous use Initial U.S. Approval: 2017 CYLTEZO (adalimumab-adbm) 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 betw20260303
62f39a7c-00df-4519-a8d4-39bbd0a649edadalimumab-adbm 40 MG in 0.8 ML Auto-Injector [PSN] · 0.8 ML adalimumab-adbm 50 MG/ML Auto-Injector [SCD] · adalimumab-adbm 40 MG per 0.8 ML Auto-Injector [SY]35These highlights do not include all the information needed to use ADALIMUMAB-ADBM safely and effectively. See full prescribing information for ADALIMUMAB-ADBM. ADALIMUMAB-ADBM injection, for subcutaneous use Initial U.S. Approval: 2017 This product is CYLTEZO ® (adalimumab-adbm). CYLTEZO (adalimumab-adbm) 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 th20251112
f9986706-9c75-4335-a54f-09d7716dbcefadalimumab-adbm 40 MG in 0.8 ML Auto-Injector [PSN] · 0.8 ML adalimumab-adbm 50 MG/ML Auto-Injector [SCD] · adalimumab-adbm 40 MG per 0.8 ML Auto-Injector [SY]33These highlights do not include all the information needed to use ADALIMUMAB-ADBM safely and effectively. See full prescribing information for ADALIMUMAB-ADBM. ADALIMUMAB-ADBM injection, for subcutaneous use Initial U.S. Approval: 2017 This product is CYLTEZO ® (adalimumab-adbm). CYLTEZO (adalimumab-adbm) 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 th20241112