FDA.reportPublic FDA data

0.5 ML tirzepatide 15 MG/ML Injection [Mounjaro]

RxCUI
2644399
RxNorm name
0.5 ML tirzepatide 15 MG/ML Injection [Mounjaro]
Display name
0.5 ML tirzepatide 15 MG/ML Injection [Mounjaro]
Full name
0.5 ML tirzepatide 15 MG/ML Injection [Mounjaro]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:22

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
MounjaroTIRZEPATIDEEli Lilly and Companyd2d7da5d-ad07-4228-955f-cf7e355c8cc02026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2644399

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
d2d7da5d-ad07-4228-955f-cf7e355c8cc0mounjaro 7.5 MG in 0.5 ML Injection [PSN] · 0.5 ML tirzepatide 15 MG/ML Injection [Mounjaro] [SBD] · 0.5 ML Mounjaro 15 MG/ML Injection [SY] · Mounjaro 7.5 MG per 0.5 ML Injection [SY]438These highlights do not include all the information needed to use MOUNJARO safely and effectively. See full prescribing information for MOUNJARO. MOUNJARO ® (tirzepatide) Injection, for subcutaneous use Initial U.S. Approval: 202220260422