FDA.reportPublic FDA data

regular insulin, human (concentrated) 500 UNT/ML Injectable Solution

RxCUI
249220
RxNorm name
regular insulin, human (concentrated) 500 UNT/ML Injectable Solution
Display name
regular insulin, human (concentrated) 500 UNT/ML Injectable Solution
Full name
regular insulin, human (concentrated) 500 UNT/ML Injectable Solution
Term type
PSN
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: 249220

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-e14675255e8cregular insulin, human (concentrated) 500 UNT/ML Injectable Solution [PSN] · insulin, regular, human 500 UNT/ML Injectable Solution [SCD] · insulin, human regular 500 UNT/ML Injectable Solution [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