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

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 Identifiers#

Field, Values table
FieldValues
Unii54Q18076QB, 839I73S42A
Rxcui1860167, 1860172

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

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