FDA.reportPublic FDA data

insulin glargine 100 UNT/ML Injectable Solution

RxCUI
311041
RxNorm name
insulin glargine 100 UNT/ML Injectable Solution
Display name
insulin glargine 100 UNT/ML Injectable Solution
Full name
insulin glargine 100 UNT/ML Injectable Solution
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:23

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021081Lantusinsulin 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
Lantus SolostarINSULIN GLARGINEsanofi-aventis U.S. LLCd5e07a0c-7e14-4756-9152-9fea485d654a2025-06-02Warnings, Adverse reactionsExact identifier
rxcui: 311041
LantusINSULIN GLARGINEA-S Medication Solutionsae27bb66-5dbe-4f01-a89e-f4fa7cb09c992023-02-04Warnings, Adverse reactionsExact identifier
rxcui: 311041

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 5 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
d5e07a0c-7e14-4756-9152-9fea485d654ainsulin glargine 100 UNT/ML Injectable Solution [PSN] · insulin glargine 100 UNT/ML Injectable Solution [SCD] · insulin analog, glargine 100 UNT/ML Injectable Solution [SY]335These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS ® (insulin glargine) injection, for subcutaneous use Initial U.S. Approval: 200020250602
ae27bb66-5dbe-4f01-a89e-f4fa7cb09c99insulin glargine 100 UNT/ML Injectable Solution [PSN] · insulin glargine 100 UNT/ML Injectable Solution [SCD] · insulin analog, glargine 100 UNT/ML Injectable Solution [SY]312These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS ® (insulin glargine) injection, for subcutaneous use Initial U.S. Approval: 200020230204
6c81d894-67eb-4c68-8af1-8cc220adb6f5insulin glargine 100 UNT/ML Injectable Solution [PSN] · insulin glargine 100 UNT/ML Injectable Solution [SCD] · insulin analog, glargine 100 UNT/ML Injectable Solution [SY]32These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 200020140109
b861fdd9-e134-436e-8c0c-a60dd0006dd3insulin glargine 100 UNT/ML Injectable Solution [PSN] · insulin glargine 100 UNT/ML Injectable Solution [SCD] · insulin analog, glargine 100 UNT/ML Injectable Solution [SY]32These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 200020100105
f2149727-c2df-41b0-97f1-45ea75e0aa1ainsulin glargine 100 UNT/ML Injectable Solution [PSN] · insulin glargine 100 UNT/ML Injectable Solution [SCD] · insulin analog, glargine 100 UNT/ML Injectable Solution [SY]31These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 200020110920