FDA.reportPublic FDA data

3 ML insulin glargine 100 UNT/ML / lixisenatide 0.033 MG/ML Pen Injector

RxCUI
1858995
RxNorm name
3 ML insulin glargine 100 UNT/ML / lixisenatide 0.033 MG/ML Pen Injector
Display name
3 ML insulin glargine 100 UNT/ML / lixisenatide 0.033 MG/ML Pen Injector
Full name
3 ML insulin glargine 100 UNT/ML / lixisenatide 0.033 MG/ML Pen Injector
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:57

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
208673Soliqua 100/33insulin glargine and lixisenatide351(a)Rx2026-08-01

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#

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
Soliqua 100/33INSULIN GLARGINE AND LIXISENATIDESanofi-Aventis U.S. LLC4bba538b-cf7c-4310-ae8f-cb711ed21bcc2026-03-18Warnings, Adverse reactionsExact identifier
rxcui: 1858995

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
4bba538b-cf7c-4310-ae8f-cb711ed21bccinsulin glargine 100 UNT/ML / lixisenatide 33 MCG/ML in 3 ML Pen Injector [PSN] · 3 ML insulin glargine 100 UNT/ML / lixisenatide 0.033 MG/ML Pen Injector [SCD] · insulin glargine 100 UNT/ML / lixisenatide 33 MCG/ML per 3 ML Pen Injector [SY]325These highlights do not include all the information needed to use SOLIQUA 100/33 safely and effectively . See full prescribing information for SOLIQUA 100/33. SOLIQUA ® 100/33 (insulin glargine and lixisenatide) injection, for subcutaneous use Initial U.S. Approval: 201620260318