FDA.reportPublic FDA data

insulin isophane (NPH), human 100 UNT/mL in 3 mL Pen Injector

RxCUI
1654862
RxNorm name
insulin isophane (NPH), human 100 UNT/mL in 3 mL Pen Injector
Display name
insulin isophane (NPH), human 100 UNT/mL in 3 mL Pen Injector
Full name
insulin isophane (NPH), human 100 UNT/mL in 3 mL Pen Injector
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:28

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
019959Novolin Ninsulin isophane human351(a)OTC2026-07-01
018781Humulin Ninsulin isophane 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Humulin NINSULIN HUMANEli Lilly and Companyf6edd793-440b-40c2-96b5-c16133b7a9212025-12-19Warnings, Adverse reactionsExact identifier
rxcui: 1654862
Novolin NHUMAN INSULINNovo Nordisk82f1445c-b2c6-445a-82cf-ba8825fac7762022-11-23Warnings, Adverse reactionsExact identifier
rxcui: 1654862

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
f6edd793-440b-40c2-96b5-c16133b7a921insulin isophane (NPH), human 100 UNT/mL in 3 mL Pen Injector [PSN] · 3 ML insulin isophane, human 100 UNT/ML Pen Injector [SCD] · insulin isophane (NPH), human 100 UNT/ML per 3 ML Pen Injector [SY] · insulin isophane U-100 per 3 ML Pen Injector [SY]450These highlights do not include all the information needed to use HUMULIN N safely and effectively. See full prescribing information for HUMULIN N. HUMULIN N (insulin isophane human) injectable suspension, for subcutaneous use Initial U.S. Approval: 198220251219
82f1445c-b2c6-445a-82cf-ba8825fac776insulin isophane (NPH), human 100 UNT/mL in 3 mL Pen Injector [PSN] · 3 ML insulin isophane, human 100 UNT/ML Pen Injector [SCD] · insulin isophane (NPH), human 100 UNT/ML per 3 ML Pen Injector [SY] · insulin isophane U-100 per 3 ML Pen Injector [SY]417These highlights do not include all the information needed to use NOVOLIN N safely and effectively. See full prescribing information for NOVOLIN N. NOVOLIN ® N (insulin isophane human) injectable suspension, for subcutaneous use Initial U.S. Approval: 199120221123
69dffec8-6ea9-441b-b795-042dcc26843dinsulin isophane (NPH), human 100 UNT/mL in 3 mL Pen Injector [PSN] · 3 ML insulin isophane, human 100 UNT/ML Pen Injector [SCD] · insulin isophane (NPH), human 100 UNT/ML per 3 ML Pen Injector [SY] · insulin isophane U-100 per 3 ML Pen Injector [SY]41These highlights do not include all the information needed to use NOVOLIN N safely and effectively. See full prescribing information for NOVOLIN N. NOVOLIN ® N (insulin isophane human) injectable suspension, for subcutaneous use Initial U.S. Approval: 199120230721