FDA.reportPublic FDA data

3 ML insulin, regular, human 500 UNT/ML Pen Injector [Humulin R]

RxCUI
1731317
RxNorm name
3 ML insulin, regular, human 500 UNT/ML Pen Injector [Humulin R]
Display name
3 ML insulin, regular, human 500 UNT/ML Pen Injector [Humulin R]
Full name
3 ML insulin, regular, human 500 UNT/ML Pen Injector [Humulin R]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:17

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
018780Humulin R U-100insulin human351(a)OTC2026-07-01

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
Humulin R U-500INSULIN HUMANEli Lilly and Companyb60e8dd0-1d48-4dc9-87fd-e14675255e8c2024-02-22Warnings, Adverse reactionsExact identifier
rxcui: 1731317

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
b60e8dd0-1d48-4dc9-87fd-e14675255e8cHumuLIN R (concentrated) 500 UNT/ML in 3 ML Pen Injector [PSN] · 3 ML insulin, regular, human 500 UNT/ML Pen Injector [Humulin R] [SBD] · 3 ML Humulin R 500 UNT/ML Pen Injector [SY]340These highlights do not include all the information needed to use HUMULIN R U-500 safely and effectively. See full prescribing information for HUMULIN R U-500. HUMULIN R U-500 (insulin human) injection, for subcutaneous use Initial U.S. Approval: 199420240222