FDA.reportPublic FDA data

1.5 ML insulin glargine 300 UNT/ML Pen Injector [Toujeo]

RxCUI
1604544
RxNorm name
1.5 ML insulin glargine 300 UNT/ML Pen Injector [Toujeo]
Display name
1.5 ML insulin glargine 300 UNT/ML Pen Injector [Toujeo]
Full name
1.5 ML insulin glargine 300 UNT/ML Pen Injector [Toujeo]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:21

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
206538Toujeoinsulin glargine351(a)Rx2026-07-01

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOUJEOINSULIN GLARGINESanofi-Aventis U.S. LLCc9561d96-124d-48ca-982f-0aa1575bff362025-05-30Warnings, Adverse reactionsExact identifier
rxcui: 1604544
TOUJEOINSULIN GLARGINEA-S Medication Solutions257ca17b-6ff7-4f2e-9037-4c185bac57682023-04-27Warnings, Adverse reactionsExact identifier
rxcui: 1604544

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
c9561d96-124d-48ca-982f-0aa1575bff36Toujeo 300 UNT/ML in 1.5 ML Pen Injector [PSN] · 1.5 ML insulin glargine 300 UNT/ML Pen Injector [Toujeo] [SBD] · 1.5 ML Toujeo 300 UNT/ML Pen Injector [SY] · Toujeo 300 UNT/ML 1.5 ML Prefilled Pen [SY]425These highlights do not include all the information needed to use TOUJEO ® U-300 safely and effectively. See full prescribing information for TOUJEO ® U-300. TOUJEO U-300 (insulin glargine) injection, for subcutaneous use Initial U.S. Approval: 201520250530
257ca17b-6ff7-4f2e-9037-4c185bac5768Toujeo 300 UNT/ML in 1.5 ML Pen Injector [PSN] · 1.5 ML insulin glargine 300 UNT/ML Pen Injector [Toujeo] [SBD] · 1.5 ML Toujeo 300 UNT/ML Pen Injector [SY] · Toujeo 300 UNT/ML 1.5 ML Prefilled Pen [SY]413These highlights do not include all the information needed to use TOUJEO U-300 safely and effectively. See full prescribing information for TOUJEO ® U-300. TOUJEO U-300 (insulin glargine) injection, for subcutaneous use Initial U.S. Approval: 201520230427