FDA.reportPublic FDA data

insulin glargine-yfgn 100 UNT/ML Injectable Solution [Semglee]

RxCUI
2563977
RxNorm name
insulin glargine-yfgn 100 UNT/ML Injectable Solution [Semglee]
Display name
insulin glargine-yfgn 100 UNT/ML Injectable Solution [Semglee]
Full name
insulin glargine-yfgn 100 UNT/ML Injectable Solution [Semglee]
Term type
SBD
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SEMGLEEINSULIN GLARGINE-YFGNBiocon Biologics Inc.8cf5544f-87d6-468b-f6ae-898b1fdb5d802025-03-03Warnings, Adverse reactionsExact identifier
rxcui: 2563977

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
8cf5544f-87d6-468b-f6ae-898b1fdb5d80Semglee (insulin glargine-yfgn) 100 UNT/ML Injectable Solution [PSN] · insulin glargine-yfgn 100 UNT/ML Injectable Solution [Semglee] [SBD] · Semglee (insulin glargine-yfgn) 100 UNT/ML Injectable Solution [SY]314These 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