FDA.reportPublic FDA data

Tresiba

Product NDC
50090-3491
11-digit product format
500903491
Labeler code
50090
Product ID
50090-3491_ee96b54f-5204-4b1b-8e9c-593f56045b66
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
200 U/mL
Pharmacologic classes
Insulin Analog [EPC], Insulin [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tresiba
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN DEGLUDEC200 U/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
54Q18076QBInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1670021Internal RxNorm lookup
1670023Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
84197351-cb71-4282-8217-13103404a2b4Available on FDA.report

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
50090-3491-0Tresiba3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION311
50090-3491-0Tresiba3 in 1 CARTONINJECTION, SOLUTION311

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3491-0ML - Milliliter50090-34916088bf64-a494-4641-8860-a77c4e28ac1812024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3491TRESIBA (INSULIN DEGLUDEC) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 2 package rows20231213_84197351-cb71-4282-8217-13103404a2b4.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
ndc (product): 50090-3491
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
1670021insulin degludec 200 UNT/ML in 3 ML Pen InjectorPSN84197351-cb71-4282-8217-13103404a2b411
1670023Tresiba 200 UNT/ML in 3 ML Pen InjectorPSN84197351-cb71-4282-8217-13103404a2b411
16700233 ML insulin degludec 200 UNT/ML Pen Injector [Tresiba]SBD84197351-cb71-4282-8217-13103404a2b411
16700213 ML insulin degludec 200 UNT/ML Pen InjectorSCD84197351-cb71-4282-8217-13103404a2b411
16700233 ML Tresiba 200 UNT/ML Pen InjectorSY84197351-cb71-4282-8217-13103404a2b411
1670021insulin degludec 200 UNT/ML per 3 ML Pen InjectorSY84197351-cb71-4282-8217-13103404a2b411
1670023Tresiba 200 UNT/ML per 3 ML Pen InjectorSY84197351-cb71-4282-8217-13103404a2b411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3491-0500903491003 SYRINGE, PLASTIC in 1 CARTON (50090-3491-0) / 3 mL in 1 SYRINGE, PLASTIC2018-06-200000-00-00NoNoCurrent