FDA.reportPublic FDA data

Omvoh Prefilled Pen 300 MG Dose Carton - Crohn's Disease

RxCUI
2703052
RxNorm name
Omvoh Prefilled Pen 300 MG Dose Carton - Crohn's Disease
Display name
Omvoh Prefilled Pen 300 MG Dose Carton - Crohn's Disease
Full name
Omvoh Prefilled Pen 300 MG Dose Carton - Crohn's Disease
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
761279Omvohmirikizumab-mrkz351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
472cbe04-263e-433d-9a0f-58c1b50b715aOmvoh Prefilled Pen 300 MG Dose Carton - Crohn's DiseaseSY18These highlights do not include all the information needed to use OMVOH safely and effectively. See full prescribing information for OMVOH. OMVOH (mirikizumab-mrkz) injection, for intravenous or subcutaneous use Initial U.S. Approval: 202320251104
472cbe04-263e-433d-9a0f-58c1b50b715aomvoh Prefilled Pen 300 MG Dose Carton - Crohn's DiseasePSN18These highlights do not include all the information needed to use OMVOH safely and effectively. See full prescribing information for OMVOH. OMVOH (mirikizumab-mrkz) injection, for intravenous or subcutaneous use Initial U.S. Approval: 202320251104
472cbe04-263e-433d-9a0f-58c1b50b715a{1 (1 ML mirikizumab-mrkz 100 MG/ML Auto-Injector [Omvoh]) / 1 (2 ML mirikizumab-mrkz 100 MG/ML Auto-Injector [Omvoh]) } Pack [Omvoh Prefilled Pen 300 MG Dose Carton]BPCK18These highlights do not include all the information needed to use OMVOH safely and effectively. See full prescribing information for OMVOH. OMVOH (mirikizumab-mrkz) injection, for intravenous or subcutaneous use Initial U.S. Approval: 202320251104