FDA.reportPublic FDA data

Tresiba 200 UNT/ML in 3 ML Pen Injector

RxCUI
1670023
RxNorm name
Tresiba 200 UNT/ML in 3 ML Pen Injector
Display name
Tresiba 200 UNT/ML in 3 ML Pen Injector
Full name
Tresiba 200 UNT/ML in 3 ML Pen Injector
Term type
PSN
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
TRESIBAINSULIN DEGLUDECA-S Medication Solutionse8ccd2f4-6ba9-4839-87f8-4742dc9b1c172024-02-22Warnings, Adverse reactionsExact identifier
rxcui: 1670023
TresibaINSULIN DEGLUDECA-S Medication Solutions84197351-cb71-4282-8217-13103404a2b42023-12-12Warnings, Adverse reactionsExact identifier
rxcui: 1670023
TresibaINSULIN DEGLUDECNovo Nordisk456c5e87-3dfd-46fa-8ac0-c6128d4c97c62022-07-01Warnings, Adverse reactionsExact identifier
rxcui: 1670023

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
456c5e87-3dfd-46fa-8ac0-c6128d4c97c6Tresiba 200 UNT/ML in 3 ML Pen Injector [PSN] · 3 ML insulin degludec 200 UNT/ML Pen Injector [Tresiba] [SBD] · 3 ML Tresiba 200 UNT/ML Pen Injector [SY] · Tresiba 200 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
84197351-cb71-4282-8217-13103404a2b4Tresiba 200 UNT/ML in 3 ML Pen Injector [PSN] · 3 ML insulin degludec 200 UNT/ML Pen Injector [Tresiba] [SBD] · 3 ML Tresiba 200 UNT/ML Pen Injector [SY] · Tresiba 200 UNT/ML per 3 ML Pen Injector [SY]411These 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: 201520231212
e8ccd2f4-6ba9-4839-87f8-4742dc9b1c17Tresiba 200 UNT/ML in 3 ML Pen Injector [PSN] · 3 ML insulin degludec 200 UNT/ML Pen Injector [Tresiba] [SBD] · 3 ML Tresiba 200 UNT/ML Pen Injector [SY] · Tresiba 200 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: 201520240222