FDA.reportPublic FDA data

3 ML insulin degludec 100 UNT/ML Pen Injector [Tresiba]

RxCUI
1670016
RxNorm name
3 ML insulin degludec 100 UNT/ML Pen Injector [Tresiba]
Display name
3 ML insulin degludec 100 UNT/ML Pen Injector [Tresiba]
Full name
3 ML insulin degludec 100 UNT/ML Pen Injector [Tresiba]
Term type
SBD
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TresibaINSULIN DEGLUDECNovo Nordisk456c5e87-3dfd-46fa-8ac0-c6128d4c97c62022-07-01Warnings, Adverse reactionsExact identifier
rxcui: 1670016

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
456c5e87-3dfd-46fa-8ac0-c6128d4c97c6Tresiba 100 UNT/ML in 3 ML Pen Injector [PSN] · 3 ML insulin degludec 100 UNT/ML Pen Injector [Tresiba] [SBD] · 3 ML Tresiba 100 UNT/ML Pen Injector [SY] · Tresiba 100 UNT/ML per 3 ML Pen Injector [SY]414These 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
afb63b26-5f28-4679-8a8b-5933ddf77fdcTresiba 100 UNT/ML in 3 ML Pen Injector [PSN] · 3 ML insulin degludec 100 UNT/ML Pen Injector [Tresiba] [SBD] · 3 ML Tresiba 100 UNT/ML Pen Injector [SY] · Tresiba 100 UNT/ML per 3 ML Pen Injector [SY]41These 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