NDC 0169-3205

Fiasp

Insulin Aspart Injection

Fiasp is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Novo Nordisk. The primary component is Insulin Aspart.

Product ID0169-3205_0d8112c7-3e31-4272-911f-06e803633178
NDC0169-3205
Product TypeHuman Prescription Drug
Proprietary NameFiasp
Generic NameInsulin Aspart Injection
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2018-09-24
Marketing CategoryBLA / NDA
Application NumberBLA208751
Labeler NameNovo Nordisk
Substance NameINSULIN ASPART
Active Ingredient Strength100 [iU]/mL
Pharm ClassesInsulin [CS],Insulin Analog [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0169-3205-15

5 CARTRIDGE in 1 CARTON (0169-3205-15) > 3 mL in 1 CARTRIDGE (0169-3205-11)
Marketing Start Date2019-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0169-3205-11 [00169320511]

Fiasp INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208751
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-10-30

NDC 0169-3205-95 [00169320595]

Fiasp INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208751
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-10-01

NDC 0169-3205-15 [00169320515]

Fiasp INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208751
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-10-01

NDC 0169-3205-91 [00169320591]

Fiasp INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA208751
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-10-30

Drug Details

Active Ingredients

IngredientStrength
INSULIN ASPART100 [iU]/mL

OpenFDA Data

SPL SET ID:834e7efc-393f-4c55-9125-628562a8a5cf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1653202
  • 311040
  • 1986354
  • 1986356
  • Pharmacological Class

    • Insulin [CS]
    • Insulin Analog [EPC]

    NDC Crossover Matching brand name "Fiasp" or generic name "Insulin Aspart Injection"

    NDCBrand NameGeneric Name
    0169-3201Fiaspinsulin aspart injection
    0169-3204Fiaspinsulin aspart injection
    0169-3205Fiaspinsulin aspart injection

    Trademark Results [Fiasp]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FIASP
    FIASP
    79162960 4966787 Live/Registered
    Novo Nordisk A/S
    2015-02-09
    FIASP
    FIASP
    79140450 4541341 Live/Registered
    Novo Nordisk A/S
    2013-10-28

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