Xultophy 100/3.6 (Page 12 of 12)

PACKAGE/LABEL 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

5×3 mL Prefilled Pens

For subcutaneous use only

Rx 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.

Dispense in this sealed carton.

Trade Carton
(click image for full-size original)
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 (INSULIN DEGLUDEC) INSULIN DEGLUDEC 100 [iU] in 1 mL
LIRAGLUTIDE (LIRAGLUTIDE) LIRAGLUTIDE 3.6 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 19.7 mg in 1 mL
PHENOL 5.70 mg in 1 mL
ZINC 55 ug in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0169-2911-15 5 SYRINGE, PLASTIC in 1 CARTON contains a SYRINGE, PLASTIC
1 3 mL in 1 SYRINGE, PLASTIC This package is contained within the CARTON (0169-2911-15)
2 NDC:0169-2911-97 1 SYRINGE, PLASTIC in 1 CARTON contains a SYRINGE, PLASTIC (0169-2911-90)
2 NDC:0169-2911-90 3 mL in 1 SYRINGE, PLASTIC This package is contained within the CARTON (0169-2911-97)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA208583 11/21/2016
Labeler — Novo Nordisk (622920320)

Revised: 11/2019 Novo Nordisk

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