NDC Code(s) : 0169-3201-11, 0169-3201-90, 0169-3204-15, 0169-3204-90, 0169-3204-97, 0169-3205-11, 0169-3205-15, 0169-3205-91, 0169-3205-95, 0169-3206-11, 0169-3206-15, 0169-3206-91, 0169-3206-95
Packager : Novo Nordisk

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Fiaspinsulin aspart injection INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-3201
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN ASPART(UNII: D933668QVX)
(INSULIN ASPART - UNII:D933668QVX) 		INSULIN ASPART100 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-3201-111 in 1 CARTON 20/10/2017
110 mL in 1 VIAL, GLASS Type 0: Not a Combination Product
2NDC:0169-3201-901 in 1 CARTON 20/10/2017
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 BLA208751 10/20/2017
Fiaspinsulin aspart injection INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-3204
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN ASPART(UNII: D933668QVX)
(INSULIN ASPART - UNII:D933668QVX) 		INSULIN ASPART100 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM(UNII: GR686LBA74)0.42 mg in 1 mL
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-3204-155 in 1 CARTON 20/10/2017
13 mL in 1 SYRINGE, PLASTIC Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2NDC:0169-3204-971 in 1 CARTON 20/10/2017
2NDC:0169-3204-903 mL in 1 SYRINGE, PLASTIC Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA208751 10/20/2017
Fiaspinsulin aspart injection INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-3205
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN ASPART(UNII: D933668QVX)
(INSULIN ASPART - UNII:D933668QVX) 		INSULIN ASPART100 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM(UNII: GR686LBA74)0.42 mg in 1 mL
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-3205-155 in 1 CARTON 10/01/2019
1NDC:0169-3205-113 mL in 1 CARTRIDGE Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2NDC:0169-3205-955 in 1 CARTON 10/01/2019
2NDC:0169-3205-913 mL in 1 CARTRIDGE Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA208751 10/20/2017
Fiaspinsulin aspart INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0169-3206
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN ASPART(UNII: D933668QVX)
(INSULIN ASPART - UNII:D933668QVX) 		INSULIN ASPART100 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-3206-155 in 1 CARTON 14/09/2023
1NDC:0169-3206-111.6 mL in 1 CARTRIDGE Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2NDC:0169-3206-955 in 1 CARTON 14/09/2023
2NDC:0169-3206-911.6 mL in 1 CARTRIDGE Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA208751 10/20/2017

LABELER - Novo Nordisk(622920320)

PRINCIPAL DISPLAY PANEL

NDC 0169-3201-11 List 320111

FIASP ®

(insulin apart) injection

100 units/mL (U-100)

For subcutaneous or intravenous use

  •  Rx only One 10 mL multi-dose vial
Fiasp Vial 8-0911-31-301-X

PRINCIPAL DISPLAY PANEL

NDC 0169-3204-15 List 320415

FIASP ®FlexTouch ®

(insulin aspart) injection

For Single-Patient Use Only

100 units/mL (U-100)

For subcutaneous use only

Rx Only

Recommended for use with NovoFine® or

NovoFine® Plus disposable needles.

Keep in a refrigerator at 36° to 46°F (2° to 8°C) until first use.

After first use store at 36° to 86°F (2° to 30°C) up to 28 days.

Do not freeze.

Protect from light.

Dispense in this sealed carton.

5×3 mL Prefilled Pens

Fiasp - FlexTouch Carton 8-9505-31-301-X

PRINCIPAL DISPLAY PANEL

  •  NDC 0169-3205-15 List 320515

FIASP® PenFill®

(insulin aspart) injection

For Single-Patient Use Only

100 units/mL (U-100)

For Subcutaneous Use

For use with Novo Nordisk 3 mL PenFill® cartridge compatible delivery devices, NovoPen® Echo®, and NovoFine®/NovoFine® Plus disposable needles.

Not in-use (unopened) cartridges: Refrigerate at 36°F to 46°F (2°C to 8°C) in the original carton. In-use (opened) cartridge: Keep at room temperature below 86°F (30°C). Once stored at room temperature, discard after 28 days. Do not freeze. Protect from light.

Rx only

3 mL cartridges

5 cartridges per package

Fiasp PenFill Carton 8-0910-31-301-X

PRINCIPAL DISPLAY PANEL

NDC 0169-3206-15 List 320615

  •   Fiasp ® PumpCart®

(insulin aspart) injection

For Single-Patient Use Only

100 units/mL (U-100)

For use with a compatible insulin pump only

For Subcutaneous Use

Not in-use (unopened) cartridges: Refrigerate at 36°F to 46°F (2°C to 8°C) until expiration or for up to 18 days below 86°F (30°C) in the original carton.

In-use (opened) cartridges: Keep below 98.6°F (37°C) for up to 4 days.

Do not freeze. Protect from light.

Rx only

1.6 mL cartridges

5 cartridges per package

Fiasp PumpCart Carton - 8-0912-31-301-1