FDA.reportPublic FDA data

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

RxCUI
2665419
RxNorm name
0.8 ML adalimumab-adaz 50 MG/ML Auto-Injector
Display name
0.8 ML adalimumab-adaz 50 MG/ML Auto-Injector
Full name
0.8 ML adalimumab-adaz 50 MG/ML Auto-Injector
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:55

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761071Hyrimozadalimumab-adaz351(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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYRIMOZADALIMUMAB-ADAZCordavis Limited3e303a4a-980b-4f2a-9d03-7869287586372025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2665419

DailyMed RxNorm Mappings#

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

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
3e303a4a-980b-4f2a-9d03-786928758637adalimumab-adaz 40 MG in 0.8 ML Auto-Injector [PSN] · 0.8 ML adalimumab-adaz 50 MG/ML Auto-Injector [SCD] · adalimumab-adaz 40 MG per 0.8 ML Auto-Injector [SY]37These highlights do not include all the information needed to use HYRIMOZ ® safely and effectively. See full prescribing information for HYRIMOZ. HYRIMOZ (adalimumab-adaz) injection, for subcutaneous use Initial U.S. Approval: 2018 HYRIMOZ (adalimumab-adaz) is biosimilar* to HUMIRA ® (adalimumab)20251017