NDC Code(s) : 73070-403-15, 73070-503-15, 73070-400-11
Packager : Novo Nordisk Pharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Insulin Degludecinsulin degludec INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:73070-403
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:73070-403-155 in 1 CARTON 07/01/2022
13 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 07/01/2022
Insulin Degludecinsulin degludec INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:73070-503
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:73070-503-153 in 1 CARTON 07/01/2022
13 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 07/01/2022
Insulin Degludecinsulin degludec INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:73070-400
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:73070-400-111 in 1 CARTON 07/01/2022
110 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 07/01/2022

LABELER - Novo Nordisk Pharma, Inc.(117032563)

Establishment
Name Address ID/FEI Business Operations
Novo Nordisk A/S 305914798 MANUFACTURE(73070-403, 73070-503, 73070-400)

Establishment
Name Address ID/FEI Business Operations
Novo Nordisk A/S 305156788 API MANUFACTURE(73070-403, 73070-503, 73070-400)

Establishment
Name Address ID/FEI Business Operations
Novo Nordisk Pharmaceutical Industries, LP 622920320 MANUFACTURE(73070-403, 73070-503, 73070-400)

PRINCIPAL DISPLAY PANEL

NDC 73070-400-11 List 040011

Insulin Degludec

  •  Injection

100 units/mL (U-100)

For subcutaneous use only

  •  Rx Only

This product is Tresiba (insulin degludec).

Use only with a U-100 syringe.

10 mL multiple-dose vial

Vial carton

PRINCIPAL DISPLAY PANEL

NDC 73070-403-15 List: 040315

Insulin Degludec

Injection

FlexTouch®

For Single Patient Use Only

100 units/mL (U-100)

This product is Tresiba (insulin degludec).

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.

FT U100

PRINCIPAL DISPLAY PANEL

  •   NDC 73070-503-15List: 050315

Insulin Degludec

Injection

FlexTouch®

For Single Patient Use Only

200 units/mL (U-200)

This product is Tresiba (insulin degludec).

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.

FT U200