FDA.reportPublic FDA data

insulin glargine 300 UNT/ML in 1.5 ML Pen Injector

RxCUI
1604539
RxNorm name
insulin glargine 300 UNT/ML in 1.5 ML Pen Injector
Display name
insulin glargine 300 UNT/ML in 1.5 ML Pen Injector
Full name
insulin glargine 300 UNT/ML in 1.5 ML Pen Injector
Term type
PSN
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 · 3 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: 1604539
Insulin glargine U-300 MaxINSULIN GLARGINESanofi-Aventis U.S. LLC99ea856d-9562-443a-9422-1006a3cff2f42025-05-30Warnings, Adverse reactionsExact identifier
rxcui: 1604539
TOUJEOINSULIN GLARGINEA-S Medication Solutions257ca17b-6ff7-4f2e-9037-4c185bac57682023-04-27Warnings, Adverse reactionsExact identifier
rxcui: 1604539

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
c9561d96-124d-48ca-982f-0aa1575bff36insulin glargine 300 UNT/ML in 1.5 ML Pen Injector [PSN] · 1.5 ML insulin glargine 300 UNT/ML Pen Injector [SCD] · insulin glargine 300 UNT/ML per 1.5 ML Pen Injector [SY]325These 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-9037-4c185bac5768insulin glargine 300 UNT/ML in 1.5 ML Pen Injector [PSN] · 1.5 ML insulin glargine 300 UNT/ML Pen Injector [SCD] · insulin glargine 300 UNT/ML per 1.5 ML Pen Injector [SY]313These 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
99ea856d-9562-443a-9422-1006a3cff2f4insulin glargine 300 UNT/ML in 1.5 ML Pen Injector [PSN] · 1.5 ML insulin glargine 300 UNT/ML Pen Injector [SCD] · insulin glargine 300 UNT/ML per 1.5 ML Pen Injector [SY]37These highlights do not include all the information needed to use INSULIN GLARGINE, U-300 safely and effectively. See full prescribing information for INSULIN GLARGINE, U-300. INSULIN GLARGINE, U-300, injection, for subcutaneous use Initial U.S. Approval: 2015 This product is TOUJEO ® (insulin glargine).20250530