FDA.reportPublic FDA data

0.8 ML Hadlima 50 MG/ML Prefilled Syringe

RxCUI
2640305
RxNorm name
0.8 ML Hadlima 50 MG/ML Prefilled Syringe
Display name
0.8 ML Hadlima 50 MG/ML Prefilled Syringe
Full name
0.8 ML Hadlima 50 MG/ML Prefilled Syringe
Term type
SY
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.

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
HADLIMAADALIMUMAB-BWWDA-S Medication Solutions7345f276-102e-4175-b7ef-ff1706b054722023-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2640305

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
4774a951-3ce8-43b6-80b1-e6b23752aae6HADLIMA 40 MG in 0.8 ML Prefilled Syringe [PSN] · 0.8 ML adalimumab-bwwd 50 MG/ML Prefilled Syringe [Hadlima] [SBD] · 0.8 ML Hadlima 50 MG/ML Prefilled Syringe [SY] · Hadlima 40 MG per 0.8 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
7345f276-102e-4175-b7ef-ff1706b05472HADLIMA 40 MG in 0.8 ML Prefilled Syringe [PSN] · 0.8 ML adalimumab-bwwd 50 MG/ML Prefilled Syringe [Hadlima] [SBD] · 0.8 ML Hadlima 50 MG/ML Prefilled Syringe [SY] · Hadlima 40 MG per 0.8 ML Prefilled Syringe [SY]43These 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* to HUMIRA (adalimumab)20231023