NDC Code(s) : 0169-2911-15, 0169-2911-90, 0169-2911-97
Packager : Novo Nordisk

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Xultophy 100/3.6(insulin degludec and liraglutide) INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-2911
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN DEGLUDEC(UNII: 54Q18076QB)
(INSULIN DEGLUDEC - UNII:54Q18076QB) 		INSULIN DEGLUDEC100 [iU] in 1 mL
LIRAGLUTIDE(UNII: 839I73S42A)
(LIRAGLUTIDE - UNII:839I73S42A) 		LIRAGLUTIDE3.6 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN(UNII: PDC6A3C0OX)19.7 mg in 1 mL
PHENOL(UNII: 339NCG44TV)5.70 mg in 1 mL
ZINC(UNII: J41CSQ7QDS)55 ug in 1 mL
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-2911-155 in 1 CARTON 21/11/2016
13 mL in 1 SYRINGE, PLASTIC Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0169-2911-971 in 1 CARTON 21/11/2016
2NDC:0169-2911-903 mL in 1 SYRINGE, PLASTIC Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA208583 11/21/2016

LABELER - Novo Nordisk(622920320)

PRINCIPAL DISPLAY PANEL

Xultophy® 100/3.6

NDC 0169-2911-15

List: 291115

(insulin degludec and liraglutide) injection

For Single Patient Use Only

100 units/mL and 3.6 mg/mL

With each unit of insulin degludec, the pen

also delivers 0.036 mg of liraglutide

5x3 mL Prefilled Pens

For subcutaneous use only

Recommended for use with NovoFine®,

Novofine® Plus or NovoTwist® disposable needles.

Must be refrigerated until first use.

Store at 36°F – 46°F (2°C – 8°C).

Do not freeze.

Protect from light.

Rx Only

Dispense in this sealed carton.

ATTENTION: Dispense the enclosed Medication Guide to each patient.

Image of Xultophy carton.