FDA.reportPublic FDA data

Gomekli 1 MG Tablet for Oral Suspension

RxCUI
2705635
RxNorm name
Gomekli 1 MG Tablet for Oral Suspension
Display name
Gomekli 1 MG Tablet for Oral Suspension
Full name
Gomekli 1 MG Tablet for Oral Suspension
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:57

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
GomekliMIRDAMETINIBSpringWorks Therapeutics, Inc.4c41bf90-5fa7-4935-a95c-e047ea6bbf8e2026-07-10Warnings, Adverse reactionsExact identifier
rxcui: 2705635

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
4c41bf90-5fa7-4935-a95c-e047ea6bbf8eGomekli 1 MG Tablet for Oral SuspensionSY6These highlights do not include all the information needed to use GOMEKLI safely and effectively. See full prescribing information for GOMEKLI. GOMEKLI TM (mirdametinib) capsules, for oral use GOMEKLI TM (mirdametinib) tablets for oral suspension Initial U.S. Approval: 202520260511
4c41bf90-5fa7-4935-a95c-e047ea6bbf8eGOMEKLI 1 MG Tablet for Oral SuspensionPSN6These highlights do not include all the information needed to use GOMEKLI safely and effectively. See full prescribing information for GOMEKLI. GOMEKLI TM (mirdametinib) capsules, for oral use GOMEKLI TM (mirdametinib) tablets for oral suspension Initial U.S. Approval: 202520260511
4c41bf90-5fa7-4935-a95c-e047ea6bbf8emirdametinib 1 MG Tablet for Oral Suspension [Gomekli]SBD6These highlights do not include all the information needed to use GOMEKLI safely and effectively. See full prescribing information for GOMEKLI. GOMEKLI TM (mirdametinib) capsules, for oral use GOMEKLI TM (mirdametinib) tablets for oral suspension Initial U.S. Approval: 202520260511