FDA.reportPublic FDA data

{1 (1 ML mirikizumab-mrkz 100 MG/ML Prefilled Syringe [Omvoh]) / 1 (2 ML mirikizumab-mrkz 100 MG/ML Prefilled Syringe [Omvoh]) } Pack [Omvoh Prefilled Syringe 300 MG Dose Carton]

RxCUI
2703054
RxNorm name
{1 (1 ML mirikizumab-mrkz 100 MG/ML Prefilled Syringe [Omvoh]) / 1 (2 ML mirikizumab-mrkz 100 MG/ML Prefilled Syringe [Omvoh]) } Pack [Omvoh Prefilled Syringe 300 MG Dose Carton]
Display name
{1 (1 ML mirikizumab-mrkz 100 MG/ML Prefilled Syringe [Omvoh]) / 1 (2 ML mirikizumab-mrkz 100 MG/ML Prefilled Syringe [Omvoh]) } Pack [Omvoh Prefilled Syringe 300 MG Dose Carton]
Full name
{1 (1 ML mirikizumab-mrkz 100 MG/ML Prefilled Syringe [Omvoh]) / 1 (2 ML mirikizumab-mrkz 100 MG/ML Prefilled Syringe [Omvoh]) } Pack [Omvoh Prefilled Syringe 300 MG Dose Carton]
Term type
BPCK
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

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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmvohMIRIKIZUMAB-MRKZEli Lilly and Company472cbe04-263e-433d-9a0f-58c1b50b715a2025-11-04Warnings, Adverse reactionsExact identifier
rxcui: 2703054

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
472cbe04-263e-433d-9a0f-58c1b50b715a{1 (1 ML mirikizumab-mrkz 100 MG/ML Prefilled Syringe [Omvoh]) / 1 (2 ML mirikizumab-mrkz 100 MG/ML Prefilled Syringe [Omvoh]) } Pack [Omvoh Prefilled Syringe 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
472cbe04-263e-433d-9a0f-58c1b50b715aomvoh Prefilled Syringe 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-58c1b50b715aOmvoh Prefilled Syringe 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