FDA.reportPublic FDA data

3 ML insulin glulisine, human 100 UNT/ML Pen Injector [Apidra]

RxCUI
847261
RxNorm name
3 ML insulin glulisine, human 100 UNT/ML Pen Injector [Apidra]
Display name
3 ML insulin glulisine, human 100 UNT/ML Pen Injector [Apidra]
Full name
3 ML insulin glulisine, human 100 UNT/ML Pen Injector [Apidra]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:25

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021629Apidrainsulin glulisine351(a)Rx2026-06-01

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
ApidraINSULIN GLULISINEsanofi-aventis U.S. LLCe7af6a7a-8046-4fb4-9979-4ec4230b23aa2025-11-25Warnings, Adverse reactionsExact identifier
rxcui: 847261

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
e7af6a7a-8046-4fb4-9979-4ec4230b23aa3 ML insulin glulisine, human 100 UNT/ML Pen Injector [Apidra]SBD28These highlights do not include all the information needed to use APIDRA safely and effectively. See full prescribing information for APIDRA. APIDRA ® (insulin glulisine) injection, for subcutaneous or intravenous use Initial U.S. Approval: 200420251125
e7af6a7a-8046-4fb4-9979-4ec4230b23aa3 ML Apidra 100 UNT/ML Pen InjectorSY28These highlights do not include all the information needed to use APIDRA safely and effectively. See full prescribing information for APIDRA. APIDRA ® (insulin glulisine) injection, for subcutaneous or intravenous use Initial U.S. Approval: 200420251125
e7af6a7a-8046-4fb4-9979-4ec4230b23aaApidra 100 UNT/ML in 3 ML Pen InjectorPSN28These highlights do not include all the information needed to use APIDRA safely and effectively. See full prescribing information for APIDRA. APIDRA ® (insulin glulisine) injection, for subcutaneous or intravenous use Initial U.S. Approval: 200420251125
e7af6a7a-8046-4fb4-9979-4ec4230b23aaApidra 100 UNT/ML per 3 ML SoloSTAR PenSY28These highlights do not include all the information needed to use APIDRA safely and effectively. See full prescribing information for APIDRA. APIDRA ® (insulin glulisine) injection, for subcutaneous or intravenous use Initial U.S. Approval: 200420251125