FDA.reportPublic FDA data

3 ML insulin degludec 100 UNT/ML Pen Injector

RxCUI
1670011
RxNorm name
3 ML insulin degludec 100 UNT/ML Pen Injector
Display name
3 ML insulin degludec 100 UNT/ML Pen Injector
Full name
3 ML insulin degludec 100 UNT/ML Pen Injector
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:56

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
203314Tresibainsulin degludec351(a)Rx2026-07-01

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Insulin DegludecINSULIN DEGLUDECA-S Medication Solutions7a4bd8e5-7af4-4573-97c2-9945faf6a7dd2024-06-03Warnings, Adverse reactionsExact identifier
rxcui: 1670011
Insulin DegludecINSULIN DEGLUDECNovo Nordisk Pharma, Inc.c1be283d-4b1d-4996-b2a7-4488dbff30372022-07-01Warnings, Adverse reactionsExact identifier
rxcui: 1670011
TresibaINSULIN DEGLUDECNovo Nordisk456c5e87-3dfd-46fa-8ac0-c6128d4c97c62022-07-01Warnings, Adverse reactionsExact identifier
rxcui: 1670011

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 4 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
456c5e87-3dfd-46fa-8ac0-c6128d4c97c6insulin degludec 100 UNT/ML in 3 ML Pen Injector [PSN] · 3 ML insulin degludec 100 UNT/ML Pen Injector [SCD] · insulin degludec 100 UNT/ML per 3 ML Pen Injector [SY]314These highlights do not include all the information needed to use TRESIBA safely and effectively. See full prescribing information for TRESIBA. TRESIBA ® (insulin degludec) injection, for subcutaneous use Initial U.S. Approval: 201520220701
7a4bd8e5-7af4-4573-97c2-9945faf6a7ddinsulin degludec 100 UNT/ML in 3 ML Pen Injector [PSN] · 3 ML insulin degludec 100 UNT/ML Pen Injector [SCD] · insulin degludec 100 UNT/ML per 3 ML Pen Injector [SY]31These highlights do not include all the information needed to use INSULIN DEGLUDEC safely and effectively. See full prescribing information for INSULIN DEGLUDEC. INSULIN DEGLUDEC injection, for subcutaneous use Initial U.S. Approval: 2015 This product is Tresiba (insulin degludec).20240603
afb63b26-5f28-4679-8a8b-5933ddf77fdcinsulin degludec 100 UNT/ML in 3 ML Pen Injector [PSN] · 3 ML insulin degludec 100 UNT/ML Pen Injector [SCD] · insulin degludec 100 UNT/ML per 3 ML Pen Injector [SY]31These highlights do not include all the information needed to use TRESIBA safely and effectively. See full prescribing information for TRESIBA. TRESIBA ® (insulin degludec) injection, for subcutaneous use Initial U.S. Approval: 201520240201
c1be283d-4b1d-4996-b2a7-4488dbff3037insulin degludec 100 UNT/ML in 3 ML Pen Injector [PSN] · 3 ML insulin degludec 100 UNT/ML Pen Injector [SCD] · insulin degludec 100 UNT/ML per 3 ML Pen Injector [SY]31These highlights do not include all the information needed to use INSULIN DEGLUDEC safely and effectively. See full prescribing information for INSULIN DEGLUDEC. INSULIN DEGLUDEC injection, for subcutaneous use Initial U.S. Approval: 2015 This product is Tresiba (insulin degludec).20220701