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 ID: 0169-3205_0d8112c7-3e31-4272-911f-06e803633178
• NDC: 0169-3205
• Product Type: Human Prescription Drug
• Proprietary Name: Fiasp
• Generic Name: Insulin Aspart Injection
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2018-09-24
• Marketing Category: BLA / NDA
• Application Number: BLA208751
• Labeler Name: Novo Nordisk
• Substance Name: INSULIN ASPART
• Active Ingredient Strength: 100 [iU]/mL
• Pharm Classes: Insulin [CS],Insulin Analog [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0169-3205-15

5 CARTRIDGE in 1 CARTON (0169-3205-15) > 3 mL in 1 CARTRIDGE (0169-3205-11)

• Marketing Start Date: 2019-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0169-3205-11 [00169320511]

Fiasp INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA208751
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-10-30

NDC 0169-3205-95 [00169320595]

Fiasp INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA208751
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-10-01

NDC 0169-3205-15 [00169320515]

Fiasp INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA208751
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-10-01

NDC 0169-3205-91 [00169320591]

Fiasp INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA208751
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-10-30

Drug Details

Active Ingredients

Ingredient	Strength
INSULIN ASPART	100 [iU]/mL

OpenFDA Data

• SPL SET ID: 834e7efc-393f-4c55-9125-628562a8a5cf
• Manufacturer:
  • Novo Nordisk
• UNII:
  • D933668QVX
• 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"

NDC	Brand Name	Generic Name
0169-3201	Fiasp	insulin aspart injection
0169-3204	Fiasp	insulin aspart injection
0169-3205	Fiasp	insulin aspart injection