Fiasp

Product NDC
0169-3206
11-digit product format
001693206
Labeler code
0169
Product ID
0169-3206_133d5f6e-b40f-47b6-ab47-10dc37114d79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin aspart
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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
D933668QVXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1986354Internal RxNorm lookup
1986356Internal RxNorm lookup
2205454Internal RxNorm lookup
2642808Internal RxNorm lookup
2642809Internal RxNorm lookup
2730170Internal RxNorm lookup
2730172Internal RxNorm lookup
2730174Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
834e7efc-393f-4c55-9125-628562a8a5cfAvailable on FDA.report

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
0169-3206-11Fiasp1.6 mL in 1 CARTRIDGEINJECTION, SOLUTION1.618
0169-3206-15Fiasp5 in 1 CARTONINJECTION, SOLUTION518
0169-3206-91Fiasp1.6 mL in 1 CARTRIDGEINJECTION, SOLUTION1.618
0169-3206-95Fiasp5 in 1 CARTONINJECTION, SOLUTION518

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0169-3206-11ML - Milliliter0169-32066c92b205-5cc5-444b-b9f9-6a5c5dcd9ee512023-09-05
0169-3206-15ML - Milliliter0169-320618e1bf38-3923-4a6c-85a3-1a39e94c772912023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0169-3206FIASP (INSULIN ASPART INJECTION) INJECTION, SOLUTION FIASP (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK]18Current NDC, 4 package rows20230725_834e7efc-393f-4c55-9125-628562a8a5cf.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FiaspINSULIN ASPART INJECTIONNovo Nordisk834e7efc-393f-4c55-9125-628562a8a5cf2023-06-21Warnings, Adverse reactionsExact identifier
application number: BLA208751
ndc (product): 0169-3206

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
208751Fiaspinsulin aspart351(a)Rx2026-07-01

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 startSampleExclude flagStatus
0169-3206-11001693206111.6 mL in 1 CARTRIDGE1.6 mlHistorical
0169-3206-15001693206155 CARTRIDGE in 1 CARTON (0169-3206-15) / 1.6 mL in 1 CARTRIDGE (0169-3206-11) 5 cartridge2023-09-14NoNoCurrent
0169-3206-91001693206911.6 mL in 1 CARTRIDGE1.6 mlHistorical
0169-3206-95001693206955 CARTRIDGE in 1 CARTON (0169-3206-95) / 1.6 mL in 1 CARTRIDGE (0169-3206-91) 5 cartridge2023-09-14YesNoCurrent