FDA.reportPublic FDA data

0.4 ML adalimumab-bwwd 100 MG/ML Prefilled Syringe [Hadlima]

RxCUI
2640428
RxNorm name
0.4 ML adalimumab-bwwd 100 MG/ML Prefilled Syringe [Hadlima]
Display name
0.4 ML adalimumab-bwwd 100 MG/ML Prefilled Syringe [Hadlima]
Full name
0.4 ML adalimumab-bwwd 100 MG/ML Prefilled Syringe [Hadlima]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:56

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761059Hadlimaadalimumab-bwwd351(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.

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
4774a951-3ce8-43b6-80b1-e6b23752aae6HADLIMA 40 MG in 0.4 ML Prefilled Syringe [PSN] · 0.4 ML adalimumab-bwwd 100 MG/ML Prefilled Syringe [Hadlima] [SBD] · 0.4 ML Hadlima 100 MG/ML Prefilled Syringe [SY] · Hadlima 40 MG per 0.4 ML Prefilled Syringe [SY]413These highlights do not include all the information needed to use HADLIMA safely and effectively. See full prescribing information for HADLIMA. HADLIMA (adalimumab-bwwd) injection, for subcutaneous use Initial U.S. Approval: 2019 HADLIMA (adalimumab-bwwd) 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 betwee20251017