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) InterchangeableRx2026-06-01

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
4774a951-3ce8-43b6-80b1-e6b23752aae60.8 ML Hadlima 50 MG/ML Prefilled SyringeSY13These 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
4774a951-3ce8-43b6-80b1-e6b23752aae60.8 ML adalimumab-bwwd 50 MG/ML Prefilled Syringe [Hadlima]SBD13These 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
4774a951-3ce8-43b6-80b1-e6b23752aae6Hadlima 40 MG per 0.8 ML Prefilled SyringeSY13These 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
4774a951-3ce8-43b6-80b1-e6b23752aae6HADLIMA 40 MG in 0.8 ML Prefilled SyringePSN13These 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-ff1706b054720.8 ML Hadlima 50 MG/ML Prefilled SyringeSY3These 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
7345f276-102e-4175-b7ef-ff1706b054720.8 ML adalimumab-bwwd 50 MG/ML Prefilled Syringe [Hadlima]SBD3These 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
7345f276-102e-4175-b7ef-ff1706b05472HADLIMA 40 MG in 0.8 ML Prefilled SyringePSN3These 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
7345f276-102e-4175-b7ef-ff1706b05472Hadlima 40 MG per 0.8 ML Prefilled SyringeSY3These 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