FDA.reportPublic FDA data

TRESIBA

Product NDC
50090-7077
Requested package NDC
50090-7077-0
11-digit product format
500907077
Labeler code
50090
Product ID
50090-7077_cc399f8e-7e57-48bd-993c-2104a4b1acf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin degludec
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
A-S Medication Solutions
Application
BLA203314
Marketing category
BLA
Marketing start
2015-09-25
Substance
INSULIN DEGLUDEC
Active strength
100 U/mL
Pharmacologic classes
Insulin Analog [EPC], Insulin [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-707750090-7077-0DDiscontinued by firm2026-08-17

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0dd952e2-ff48-4739-9b8d-72ae0b326834Product name220200323
34796cf9-f067-40c8-ac2d-d04e5b83ae05Product name220200323
6a6ef80c-37d6-4e02-aa78-fce7b811234eProduct name220200323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7077-0TRESIBA5 in 1 CARTONINJECTION, SOLUTION51
50090-7077-0TRESIBA3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7077-0ML - Milliliter50090-70771939908f-cab3-4956-91cc-883259f5f32612024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7077TRESIBA (INSULIN DEGLUDEC) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20240203_afb63b26-5f28-4679-8a8b-5933ddf77fdc.zip

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 · 6 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
application number: BLA203314
Insulin DegludecINSULIN DEGLUDECA-S Medication Solutions62128c8b-f613-44d9-af04-18d52c4348cd2024-05-31Warnings, Adverse reactionsExact identifier
application number: BLA203314
TRESIBAINSULIN DEGLUDECA-S Medication Solutionse8ccd2f4-6ba9-4839-87f8-4742dc9b1c172024-02-22Warnings, Adverse reactionsExact identifier
application number: BLA203314
TresibaINSULIN DEGLUDECA-S Medication Solutions84197351-cb71-4282-8217-13103404a2b42023-12-12Warnings, Adverse reactionsExact identifier
application number: BLA203314
Insulin DegludecINSULIN DEGLUDECNovo Nordisk Pharma, Inc.c1be283d-4b1d-4996-b2a7-4488dbff30372022-07-01Warnings, Adverse reactionsExact identifier
application number: BLA203314
TresibaINSULIN DEGLUDECNovo Nordisk456c5e87-3dfd-46fa-8ac0-c6128d4c97c62022-07-01Warnings, Adverse reactionsExact identifier
application number: BLA203314

Purple Book Biologic Products#

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1670011insulin degludec 100 UNT/ML in 3 ML Pen InjectorPSNafb63b26-5f28-4679-8a8b-5933ddf77fdc1
1670016Tresiba 100 UNT/ML in 3 ML Pen InjectorPSNafb63b26-5f28-4679-8a8b-5933ddf77fdc1
16700163 ML insulin degludec 100 UNT/ML Pen Injector [Tresiba]SBDafb63b26-5f28-4679-8a8b-5933ddf77fdc1
16700113 ML insulin degludec 100 UNT/ML Pen InjectorSCDafb63b26-5f28-4679-8a8b-5933ddf77fdc1
16700163 ML Tresiba 100 UNT/ML Pen InjectorSYafb63b26-5f28-4679-8a8b-5933ddf77fdc1
1670011insulin degludec 100 UNT/ML per 3 ML Pen InjectorSYafb63b26-5f28-4679-8a8b-5933ddf77fdc1
1670016Tresiba 100 UNT/ML per 3 ML Pen InjectorSYafb63b26-5f28-4679-8a8b-5933ddf77fdc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7077-0500907077005 SYRINGE, PLASTIC in 1 CARTON (50090-7077-0) / 3 mL in 1 SYRINGE, PLASTIC2024-01-29NoNoHistorical