Fiasp (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — VIAL

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
U100 Fiasp Vial Trade
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — FLEXTOUCH

NDC 0169-3204-15 List 320415

FIASP ® FlexTouch ®

(insulin aspart injection)

For Single Patient Use Only

100 units/mL (U-100)

5×3 mL Prefilled Pens

For subcutaneous use only

Rx Only

Recommended for use with NovoFine® ,

NovoFine® Plus or NovoTwist® 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.

U100 Fiasp FlexTouch Trade
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — PenFill

NDC 0169-3205-15 List 320515

FIASP® PenFill®

(insulin aspart injection)

For Subcutaneous Use

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 or NovoTwist® 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

U100 Fiasp PenFill Trade
(click image for full-size original)
FIASP insulin 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 (INSULIN ASPART) INSULIN ASPART 100 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 0.53 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0169-3201-11 1 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS
1 10 mL in 1 VIAL, GLASS This package is contained within the CARTON (0169-3201-11)
2 NDC:0169-3201-90 1 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS
2 10 mL in 1 VIAL, GLASS This package is contained within the CARTON (0169-3201-90)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA208751 10/20/2017
FIASP insulin 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 (INSULIN ASPART) INSULIN ASPART 100 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 0.53 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0169-3204-15 5 SYRINGE, PLASTIC in 1 CARTON contains a SYRINGE, PLASTIC
1 3 mL in 1 SYRINGE, PLASTIC This package is contained within the CARTON (0169-3204-15)
2 NDC:0169-3204-97 1 SYRINGE, PLASTIC in 1 CARTON contains a SYRINGE, PLASTIC (0169-3204-90)
2 NDC:0169-3204-90 3 mL in 1 SYRINGE, PLASTIC This package is contained within the CARTON (0169-3204-97)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA208751 10/20/2017
FIASP insulin 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 (INSULIN ASPART) INSULIN ASPART 100 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0169-3205-15 5 CARTRIDGE in 1 CARTON contains a CARTRIDGE (0169-3205-11)
1 NDC:0169-3205-11 3 mL in 1 CARTRIDGE This package is contained within the CARTON (0169-3205-15)
2 NDC:0169-3205-95 5 CARTRIDGE in 1 CARTON contains a CARTRIDGE (0169-3205-91)
2 NDC:0169-3205-91 3 mL in 1 CARTRIDGE This package is contained within the CARTON (0169-3205-95)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA208751 09/24/2018
Labeler — Novo Nordisk (622920320)
Establishment
Name Address ID/FEI Operations
Novo Nordisk Pharmaceutical Industries, LP 622920320 MANUFACTURE (0169-3201)

Revised: 12/2019 Novo Nordisk

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