FDA.reportPublic FDA data

Fiasp

Product NDC
0169-3204
11-digit product format
001693204
Labeler code
0169
Product ID
0169-3204_133d5f6e-b40f-47b6-ab47-10dc37114d79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin aspart injection
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Novo Nordisk
Application
BLA208751
Marketing category
BLA
Marketing start
2017-10-20
Substance
INSULIN ASPART
Active strength
100 [iU]/mL
Pharmacologic classes
Insulin Analog [EPC], Insulin [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fiasp
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN ASPART100 [iU]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD933668QVX
Rxcui1986354, 1986356, 2205454, 2642808, 2642809, 2730170, 2730172, 2730174

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
24eab60a-55c8-40c1-8c86-7ed01a7a8befProduct name120240227
09fb02dd-baf0-4f67-b464-599bf26324b6Product name220200323
6a6ef80c-37d6-4e02-aa78-fce7b811234eProduct name220200323
91ae268d-ee0f-6988-629d-5065a4376a50Product name220200323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0169-3204-15Fiasp3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION318
0169-3204-15Fiasp5 in 1 CARTONINJECTION, SOLUTION518
0169-3204-90Fiasp3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION318
0169-3204-97Fiasp1 in 1 CARTONINJECTION, SOLUTION118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0169-3204-15ML - Milliliter0169-320444d0fe47-537a-4f92-b1d9-bc1287dafd5012017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0169-3204FIASP (INSULIN ASPART INJECTION) INJECTION, SOLUTION FIASP (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK]18Current NDC, Legacy NDC, 4 package rows20230725_834e7efc-393f-4c55-9125-628562a8a5cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2642809Fiasp 100 UNT/mL in 1.6 mL CartridgePSN834e7efc-393f-4c55-9125-628562a8a5cf18
2205454Fiasp 100 UNT/mL in 3 mL CartridgePSN834e7efc-393f-4c55-9125-628562a8a5cf18
1986356Fiasp 100 UNT/mL in 3 mL Pen InjectorPSN834e7efc-393f-4c55-9125-628562a8a5cf18
1986354Fiasp 100 UNT/mL Injectable SolutionPSN834e7efc-393f-4c55-9125-628562a8a5cf18
2730174insulin aspart (niacinamide) 100 UNT/ML Injectable SolutionPSN834e7efc-393f-4c55-9125-628562a8a5cf18
2642808insulin aspart, human 100 UNT/ML in 1.6 ML CartridgePSN834e7efc-393f-4c55-9125-628562a8a5cf18
2730170insulin, aspart, human (niacinamide) 100 UNT/ML in 3 ML CartridgePSN834e7efc-393f-4c55-9125-628562a8a5cf18
2730172insulin, aspart, human (niacinamide) 100 UNT/ML in 3 ML Pen InjectorPSN834e7efc-393f-4c55-9125-628562a8a5cf18
26428091.6 ML insulin aspart, human 100 UNT/ML Cartridge [Fiasp]SBD834e7efc-393f-4c55-9125-628562a8a5cf18
2205454Niacinamide 3 ML insulin aspart, human 100 UNT/ML Cartridge [Fiasp]SBD834e7efc-393f-4c55-9125-628562a8a5cf18
1986356Niacinamide 3 ML insulin aspart, human 100 UNT/ML Pen Injector [Fiasp]SBD834e7efc-393f-4c55-9125-628562a8a5cf18
1986354Niacinamide insulin aspart, human 100 UNT/ML Injectable Solution [Fiasp]SBD834e7efc-393f-4c55-9125-628562a8a5cf18
26428081.6 ML insulin aspart, human 100 UNT/ML CartridgeSCD834e7efc-393f-4c55-9125-628562a8a5cf18
2730170Niacinamide 3 ML insulin aspart, human 100 UNT/ML CartridgeSCD834e7efc-393f-4c55-9125-628562a8a5cf18
2730172Niacinamide 3 ML insulin aspart, human 100 UNT/ML Pen InjectorSCD834e7efc-393f-4c55-9125-628562a8a5cf18
2730174Niacinamide insulin aspart, human 100 UNT/ML Injectable SolutionSCD834e7efc-393f-4c55-9125-628562a8a5cf18
22054543 ML Fiasp 100 UNT/ML CartridgeSY834e7efc-393f-4c55-9125-628562a8a5cf18
19863563 ML Fiasp 100 UNT/ML Pen InjectorSY834e7efc-393f-4c55-9125-628562a8a5cf18
1986354Fiasp 100 UNT/ML Injectable SolutionSY834e7efc-393f-4c55-9125-628562a8a5cf18
2642809Fiasp 100 UNT/ML per 1.6 ML CartridgeSY834e7efc-393f-4c55-9125-628562a8a5cf18
2205454Fiasp 100 UNT/ML per 3 ML CartridgeSY834e7efc-393f-4c55-9125-628562a8a5cf18
2730174insulin analog, aspart (niacinamide) 100 UNT/ML Injectable SolutionSY834e7efc-393f-4c55-9125-628562a8a5cf18
2642808insulin aspart, human 100 UNT/ML per 1.6 ML CartridgeSY834e7efc-393f-4c55-9125-628562a8a5cf18
2730170insulin, aspart, human (niacinamide) 100 UNT/ML per 3 ML CartridgeSY834e7efc-393f-4c55-9125-628562a8a5cf18
2730172insulin, aspart, human (niacinamide) 100 UNT/ML per 3 ML Pen InjectorSY834e7efc-393f-4c55-9125-628562a8a5cf18
2205454Niacinamide Fiasp 100 UNT/ML CartridgeSY834e7efc-393f-4c55-9125-628562a8a5cf18
1986354Niacinamide Fiasp 100 UNT/ML Injectable SolutionSY834e7efc-393f-4c55-9125-628562a8a5cf18
1986356Niacinamide Fiasp 100 UNT/ML Pen InjectorSY834e7efc-393f-4c55-9125-628562a8a5cf18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0169-3204-15001693204155 SYRINGE, PLASTIC in 1 CARTON (0169-3204-15) / 3 mL in 1 SYRINGE, PLASTIC2017-10-200000-00-00NoNoCurrent
0169-3204-90001693204903 mL in 1 SYRINGE, PLASTIC3 mlHistorical
0169-3204-97001693204971 SYRINGE, PLASTIC in 1 CARTON (0169-3204-97) / 3 mL in 1 SYRINGE, PLASTIC (0169-3204-90) 2017-10-200000-00-00YesNoCurrent