FDA.reportPublic FDA data

Awiqli

Product NDC
0169-3105
11-digit product format
001693105
Labeler code
0169
Product ID
0169-3105_5162b93e-5775-4581-a5e9-e8783ae0acd7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Insulin icodec-abae
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Novo Nordisk
Application
BLA761326
Marketing category
BLA
Marketing start
2026-03-26
Substance
INSULIN ICODEC
Active strength
700 U/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Awiqli
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN ICODEC700 U/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP7YU3ED05N
Rxcui2740401, 2740408, 2740410, 2740411, 2740412, 2740413

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0169-3105-01Awiqli1.5 mL in 1 SYRINGEINJECTION, SOLUTION1.51
0169-3105-11Awiqli1 in 1 CARTONINJECTION, SOLUTION11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2740411Awiqli 1050 UNT in 1.5 ML Pen InjectorPSN5162b93e-5775-4581-a5e9-e8783ae0acd71
2740413Awiqli 2100 UNT in 3 ML Pen InjectorPSN5162b93e-5775-4581-a5e9-e8783ae0acd71
2740408Awiqli 700 UNT in 1 ML Pen InjectorPSN5162b93e-5775-4581-a5e9-e8783ae0acd71
2740410insulin icodec-abae 1050 UNT in 1.5 ML Pen InjectorPSN5162b93e-5775-4581-a5e9-e8783ae0acd71
2740412insulin icodec-abae 2100 UNT in 3 ML Pen InjectorPSN5162b93e-5775-4581-a5e9-e8783ae0acd71
2740401insulin icodec-abae 700 UNT in 1 ML Pen InjectorPSN5162b93e-5775-4581-a5e9-e8783ae0acd71
27404081 ML insulin icodec-abae 700 UNT/ML Pen Injector [Awiqli]SBD5162b93e-5775-4581-a5e9-e8783ae0acd71
27404111.5 ML insulin icodec-abae 700 UNT/ML Pen Injector [Awiqli]SBD5162b93e-5775-4581-a5e9-e8783ae0acd71
27404133 ML insulin icodec-abae 700 UNT/ML Pen Injector [Awiqli]SBD5162b93e-5775-4581-a5e9-e8783ae0acd71
27404011 ML insulin icodec-abae 700 UNT/ML Pen InjectorSCD5162b93e-5775-4581-a5e9-e8783ae0acd71
27404101.5 ML insulin icodec-abae 700 UNT/ML Pen InjectorSCD5162b93e-5775-4581-a5e9-e8783ae0acd71
27404123 ML insulin icodec-abae 700 UNT/ML Pen InjectorSCD5162b93e-5775-4581-a5e9-e8783ae0acd71
27404081 ML Awiqli 700 UNT/ML Pen InjectorSY5162b93e-5775-4581-a5e9-e8783ae0acd71
27404111.5 ML Awiqli 700 UNT/ML Pen InjectorSY5162b93e-5775-4581-a5e9-e8783ae0acd71
27404133 ML Awiqli 700 UNT/ML Pen InjectorSY5162b93e-5775-4581-a5e9-e8783ae0acd71
2740411Awiqli 1050 UNT per 1.5 ML Pen InjectorSY5162b93e-5775-4581-a5e9-e8783ae0acd71
2740413Awiqli 2100 UNT per 3 ML Pen InjectorSY5162b93e-5775-4581-a5e9-e8783ae0acd71
2740408Awiqli 700 UNT per 1 ML Pen InjectorSY5162b93e-5775-4581-a5e9-e8783ae0acd71
2740410insulin icodec-abae 1050 UNT per 1.5 ML Pen InjectorSY5162b93e-5775-4581-a5e9-e8783ae0acd71
2740412insulin icodec-abae 2100 UNT per 3 ML Pen InjectorSY5162b93e-5775-4581-a5e9-e8783ae0acd71
2740401insulin icodec-abae 700 UNT per 1 ML Pen InjectorSY5162b93e-5775-4581-a5e9-e8783ae0acd71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0169-3105-01001693105011.5 mL in 1 SYRINGE1.5 mlHistorical
0169-3105-11001693105111 SYRINGE in 1 CARTON (0169-3105-11) / 1.5 mL in 1 SYRINGE (0169-3105-01) 1 syringe2026-03-26NoNoCurrent