FDA.reportPublic FDA data

mirabegron 8 MG/mL 24HR Extended Release Suspension

RxCUI
2541233
RxNorm name
mirabegron 8 MG/mL 24HR Extended Release Suspension
Display name
mirabegron 8 MG/mL 24HR Extended Release Suspension
Full name
mirabegron 8 MG/mL 24HR Extended Release Suspension
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:18

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MirabegronMIRABEGRONAscend Laboratories, LLC1c9022af-4841-4f3f-9737-1c5eef58e86b2026-05-22Warnings, Adverse reactionsExact identifier
rxcui: 2541233
MyrbetriqMIRABEGRONAstellas Pharma US, Inc.ba9e9e15-e666-4c56-9271-2e24739cfa2d2024-08-01Warnings, Adverse reactionsExact identifier
rxcui: 2541233

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
ba9e9e15-e666-4c56-9271-2e24739cfa2d24 HR mirabegron 8 MG/ML Extended Release SuspensionSCD17These highlights do not include all the information needed to use MYRBETRIQ ® /MYRBETRIQ ® GRANULES safely and effectively. See full prescribing information for MYRBETRIQ/MYRBETRIQ GRANULES. MYRBETRIQ (mirabegron extended-release tablets), for oral use MYRBETRIQ GRANULES (mirabegron for extended-release oral suspension) Initial U.S. Approval: 201220240801
ba9e9e15-e666-4c56-9271-2e24739cfa2dmirabegron 8 MG/ML 24 HR Extended Release SuspensionSY17These highlights do not include all the information needed to use MYRBETRIQ ® /MYRBETRIQ ® GRANULES safely and effectively. See full prescribing information for MYRBETRIQ/MYRBETRIQ GRANULES. MYRBETRIQ (mirabegron extended-release tablets), for oral use MYRBETRIQ GRANULES (mirabegron for extended-release oral suspension) Initial U.S. Approval: 201220240801
ba9e9e15-e666-4c56-9271-2e24739cfa2dmirabegron 8 MG/mL 24HR Extended Release SuspensionPSN17These highlights do not include all the information needed to use MYRBETRIQ ® /MYRBETRIQ ® GRANULES safely and effectively. See full prescribing information for MYRBETRIQ/MYRBETRIQ GRANULES. MYRBETRIQ (mirabegron extended-release tablets), for oral use MYRBETRIQ GRANULES (mirabegron for extended-release oral suspension) Initial U.S. Approval: 201220240801
1c9022af-4841-4f3f-9737-1c5eef58e86bmirabegron 8 MG/mL 24HR Extended Release SuspensionPSN6These highlights do not include all the information needed to use MIRABEGRON FOR EXTENDED-RELEASE ORAL SUSPENSION safely and effectively. See full prescribing information for MIRABEGRON FOR EXTENDED-RELEASE ORAL SUSPENSION. MIRABEGRON for extended-release oral suspension Initial U.S. Approval: 201220260318
1c9022af-4841-4f3f-9737-1c5eef58e86b24 HR mirabegron 8 MG/ML Extended Release SuspensionSCD6These highlights do not include all the information needed to use MIRABEGRON FOR EXTENDED-RELEASE ORAL SUSPENSION safely and effectively. See full prescribing information for MIRABEGRON FOR EXTENDED-RELEASE ORAL SUSPENSION. MIRABEGRON for extended-release oral suspension Initial U.S. Approval: 201220260318
1c9022af-4841-4f3f-9737-1c5eef58e86bmirabegron 8 MG/ML 24 HR Extended Release SuspensionSY6These highlights do not include all the information needed to use MIRABEGRON FOR EXTENDED-RELEASE ORAL SUSPENSION safely and effectively. See full prescribing information for MIRABEGRON FOR EXTENDED-RELEASE ORAL SUSPENSION. MIRABEGRON for extended-release oral suspension Initial U.S. Approval: 201220260318