NDC Code(s) : 0169-2660-15, 0169-2660-90, 0169-2660-97, 0169-2550-13, 0169-2550-90, 0169-2550-97, 0169-2662-11, 0169-2662-90
Packager : Novo Nordisk

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Tresibainsulin degludec INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-2660
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 U in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN(UNII: PDC6A3C0OX)19.6 mg in 1 mL
PHENOL(UNII: 339NCG44TV)1.50 mg in 1 mL
METACRESOL(UNII: GGO4Y809LO)1.72 mg in 1 mL
ZINC(UNII: J41CSQ7QDS)32.7 ug in 1 mL
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-2660-155 in 1 CARTON 25/09/2015
13 mL in 1 SYRINGE, PLASTIC Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0169-2660-971 in 1 CARTON 25/09/2015
2NDC:0169-2660-903 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 BLA203314 09/25/2015
Tresibainsulin degludec INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-2550
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 DEGLUDEC200 U in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN(UNII: PDC6A3C0OX)19.6 mg in 1 mL
PHENOL(UNII: 339NCG44TV)1.50 mg in 1 mL
METACRESOL(UNII: GGO4Y809LO)1.72 mg in 1 mL
ZINC(UNII: J41CSQ7QDS)71.9 ug in 1 mL
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-2550-133 in 1 CARTON 25/09/2015
13 mL in 1 SYRINGE, PLASTIC Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0169-2550-971 in 1 CARTON 25/09/2015
2NDC:0169-2550-903 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 BLA203314 09/25/2015
Tresibainsulin degludec INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-2662
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 U in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN(UNII: PDC6A3C0OX)19.6 mg in 1 mL
PHENOL(UNII: 339NCG44TV)1.50 mg in 1 mL
METACRESOL(UNII: GGO4Y809LO)1.72 mg in 1 mL
ZINC(UNII: J41CSQ7QDS)32.7 ug in 1 mL
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-2662-111 in 1 CARTON 02/05/2019
110 mL in 1 VIAL, GLASS Type 0: Not a Combination Product
2NDC:0169-2662-901 in 1 CARTON 02/05/2019
210 mL in 1 VIAL, GLASS Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA203314 11/21/2018

LABELER - Novo Nordisk(622920320)

PRINCIPAL DISPLAY PANEL

  •   NDC 0169-2662-11 List 266211

TRESIBA®

  •   (insulin degludec) injection

100 units/mL (U-100)

For subcutaneous use only

  •   Use only with a U-100 syringe.
  •  Rx Only10 mL vial multiple-dose vial
Vial carton

PRINCIPAL DISPLAY PANEL

  •   NDC 0169-2660-15 List: 266015

TRESIBA®

FlexTouch®

(insulin degludec) injection

For Single Patient Use Only

100 units/mL (U-100)

5×3 mL Prefilled Pens

For subcutaneous use only

Recommended for use with NovoFine®, NovoFine® Plus or NovoTwist® disposable needles.

Keep in a cold place until first use.

Store at 36°F to 46°F (2°C to 8°C).

Do not freeze.

After first use, store between 36°F to 86°F (2°C to 30°C) for up to 56 days.

Protect from light.

Rx Only

Dispense in this sealed carton.

U100 FT carton

PRINCIPAL DISPLAY PANEL

  •   NDC 0169-2550-13 List: 255013

TRESIBA®

FlexTouch®

(insulin degludec) injection

For Single Patient Use Only

200 units/mL (U-200)

3×3 mL Prefilled Pens

For subcutaneous use only

Recommended for use with NovoFine®, NovoFine® Plus or NovoTwist® disposable needles.
disposable needles.

Keep in a cold place until first use.

Store at 36°F to 46°F (2°C to 8°C).

Do not freeze.

After first use, store between 36°F to 86°F (2°C to 30°C) for up to 56 days.

Protect from light.

Rx Only

Dispense in this sealed carton.

U200 FT carton