FDA.reportPublic FDA data

Xultophy 100/3.6

Product NDC
0169-2911
11-digit product format
001692911
Labeler code
0169
Product ID
0169-2911_7ade72ef-d354-430d-afad-3b63b95f5b39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin degludec and liraglutide
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Novo Nordisk
Application
BLA208583
Marketing category
BLA
Marketing start
2016-11-21
Substance
INSULIN DEGLUDEC; LIRAGLUTIDE
Active strength
100; 3.6 [iU]/mL; mg/mL
Pharmacologic classes
GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], 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 packagepackage0169-29110169-2911-97DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Additional Listing Data#

Finished product
Yes
Brand name base
Xultophy 100/3.6
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN DEGLUDEC100 [iU]/mL
LIRAGLUTIDE3.6 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
54Q18076QBInternal UNII lookup
839I73S42AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1860167Internal RxNorm lookup
1860172Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
21335fe4-d395-4501-ac2a-2f20d7520da9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d8dac6c8-0045-42cf-b357-c3350b4ada5cProduct name220251021
0dd952e2-ff48-4739-9b8d-72ae0b326834Product name220200323
34796cf9-f067-40c8-ac2d-d04e5b83ae05Product name220200323
6a6ef80c-37d6-4e02-aa78-fce7b811234eProduct name220200323
ce962b7e-f9f8-43e6-8d30-41514e79f3e4Product name120190201
2f360a13-6ea8-4c2b-b2ef-10133c2836d9Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0169-2911-15Xultophy 100/3.63 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION314
0169-2911-15Xultophy 100/3.65 in 1 CARTONINJECTION, SOLUTION514
0169-2911-90Xultophy 100/3.63 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION314
0169-2911-97Xultophy 100/3.61 in 1 CARTONINJECTION, SOLUTION114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0169-2911-15ML - Milliliter0169-29115c60116a-7415-4291-be6b-4ef8b971636a12016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0169-2911XULTOPHY 100/3.6 (INSULIN DEGLUDEC AND LIRAGLUTIDE) INJECTION, SOLUTION [NOVO NORDISK]12Current NDC, Legacy NDC, 4 package rows20241115_21335fe4-d395-4501-ac2a-2f20d7520da9.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Xultophy 100/3.6INSULIN DEGLUDEC AND LIRAGLUTIDENovo Nordisk21335fe4-d395-4501-ac2a-2f20d7520da92025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA208583
ndc (product): 0169-2911

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
208583Xultophy 100/3.6insulin degludec and liraglutide351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1860167insulin degludec 100 UNT/ML / liraglutide 3.6 MG/ML in 3 ML Pen InjectorPSN21335fe4-d395-4501-ac2a-2f20d7520da914
1860172Xultophy 100/3.6 in 3 ML Pen InjectorPSN21335fe4-d395-4501-ac2a-2f20d7520da914
18601723 ML insulin degludec 100 UNT/ML / liraglutide 3.6 MG/ML Pen Injector [Xultophy]SBD21335fe4-d395-4501-ac2a-2f20d7520da914
18601673 ML insulin degludec 100 UNT/ML / liraglutide 3.6 MG/ML Pen InjectorSCD21335fe4-d395-4501-ac2a-2f20d7520da914
1860167insulin degludec 100 UNT/ML / liraglutide 3.6 MG/ML per 3 ML Pen InjectorSY21335fe4-d395-4501-ac2a-2f20d7520da914
1860172Xultophy (insulin degludec 100 UNT / liraglutide 3.6 MG/ML) per 3 ML Pen InjectorSY21335fe4-d395-4501-ac2a-2f20d7520da914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0169-2911-15001692911155 SYRINGE, PLASTIC in 1 CARTON (0169-2911-15) / 3 mL in 1 SYRINGE, PLASTIC2016-11-210000-00-00NoNoCurrent
0169-2911-90001692911903 mL in 1 SYRINGE, PLASTIC3 mlHistorical
0169-2911-97001692911971 SYRINGE, PLASTIC in 1 CARTON (0169-2911-97) > 3 mL in 1 SYRINGE, PLASTIC (0169-2911-90) 2016-11-210000-00-00NoNoCurrent