FDA.reportPublic FDA data

3 ML insulin glargine-yfgn 100 UNT/ML Pen Injector

RxCUI
2563971
RxNorm name
3 ML insulin glargine-yfgn 100 UNT/ML Pen Injector
Display name
3 ML insulin glargine-yfgn 100 UNT/ML Pen Injector
Full name
3 ML insulin glargine-yfgn 100 UNT/ML Pen Injector
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:08

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761201Semgleeinsulin glargine-yfgn351(k) InterchangeableRx2026-07-01

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Insulin GlargineINSULIN GLARGINE-YFGNBiocon Biologics Inc.3ac85ebb-5594-59c8-77fd-df254329d1512026-01-23Warnings, Adverse reactionsExact identifier
rxcui: 2563971
INSULIN GLARGINEINSULIN GLARGINE-YFGNCivica, Inc.72cfe377-52f6-0348-fc71-5d4ac1992ffb2025-07-24Warnings, Adverse reactionsExact identifier
rxcui: 2563971
INSULIN GLARGINEINSULIN GLARGINE-YFGNCivica, Inc.216f2167-c201-76fe-81ed-0d51fe53832f2025-07-03Warnings, Adverse reactionsExact identifier
rxcui: 2563971
SEMGLEEINSULIN GLARGINE-YFGNBiocon Biologics Inc.8cf5544f-87d6-468b-f6ae-898b1fdb5d802025-03-03Warnings, Adverse reactionsExact identifier
rxcui: 2563971

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 4 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
8cf5544f-87d6-468b-f6ae-898b1fdb5d80insulin glargine-yfgn 300 UNT in 3 ML Pen Injector [PSN] · 3 ML insulin glargine-yfgn 100 UNT/ML Pen Injector [SCD] · insulin glargine-yfgn 100 UNT/ML per 3 ML Pen Injector [SY] · insulin glargine-yfgn 300 UNT per 3 ML Pen Injector [SY]414These highlights do not include all the information needed to use SEMGLEE safely and effectively. See full prescribing information for SEMGLEE. SEMGLEE ® (insulin glargine-yfgn) injection, for subcutaneous use Initial U.S. Approval: 2021 SEMGLEE ® (insulin glargine-yfgn) is biosimilar* to LANTUS (insulin glargine).20250303
3ac85ebb-5594-59c8-77fd-df254329d151insulin glargine-yfgn 300 UNT in 3 ML Pen Injector [PSN] · 3 ML insulin glargine-yfgn 100 UNT/ML Pen Injector [SCD] · insulin glargine-yfgn 100 UNT/ML per 3 ML Pen Injector [SY] · insulin glargine-yfgn 300 UNT per 3 ML Pen Injector [SY]48These highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN. INSULIN GLARGINE-YFGN injection, for subcutaneous use Initial U.S. Approval: 2021 This product is SEMGLEE (insulin glargine-yfgn). SEMGLEE (insulin glargine-yfgn) is biosimilar* to LANTUS (insulin glargine).20250303
72cfe377-52f6-0348-fc71-5d4ac1992ffbinsulin glargine-yfgn 300 UNT in 3 ML Pen Injector [PSN] · 3 ML insulin glargine-yfgn 100 UNT/ML Pen Injector [SCD] · insulin glargine-yfgn 100 UNT/ML per 3 ML Pen Injector [SY] · insulin glargine-yfgn 300 UNT per 3 ML Pen Injector [SY]41These highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN. INSULIN GLARGINE-YFGN injection, for subcutaneous use Initial U.S. Approval: 2021 Insulin glargine-yfgn is a biosimilar* to LANTUS (insulin glargine).20250724
216f2167-c201-76fe-81ed-0d51fe53832finsulin glargine-yfgn 300 UNT in 3 ML Pen Injector [PSN] · 3 ML insulin glargine-yfgn 100 UNT/ML Pen Injector [SCD] · insulin glargine-yfgn 100 UNT/ML per 3 ML Pen Injector [SY] · insulin glargine-yfgn 300 UNT per 3 ML Pen Injector [SY]41These highlights do not include all the information needed to use INSULIN GLARGINE-YFGN safely and effectively. See full prescribing information for INSULIN GLARGINE-YFGN. INSULIN GLARGINE-YFGN injection, for subcutaneous use Initial U.S. Approval: 2021 Insulin glargine-yfgn is a biosimilar* to LANTUS (insulin glargine).20250703