FDA.reportPublic FDA data

Awiqli

Product NDC
0169-3121
11-digit product format
001693121
Labeler code
0169
Product ID
0169-3121_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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
P7YU3ED05NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2740401Internal RxNorm lookup
2740408Internal RxNorm lookup
2740410Internal RxNorm lookup
2740411Internal RxNorm lookup
2740412Internal RxNorm lookup
2740413Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5162b93e-5775-4581-a5e9-e8783ae0acd7Available on FDA.report

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
0169-3121-01Awiqli3 mL in 1 SYRINGEINJECTION, SOLUTION31
0169-3121-13Awiqli1 in 1 CARTONINJECTION, SOLUTION11

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
AwiqliINSULIN ICODEC-ABAENovo Nordisk5162b93e-5775-4581-a5e9-e8783ae0acd72026-03-26Warnings, Adverse reactionsExact identifier
application number: BLA761326
ndc (product): 0169-3121

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761326Awiqliinsulin icodec-abae351(a)Rx2026-07-01

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
0169-3121-01001693121013 mL in 1 SYRINGE3 mlHistorical
0169-3121-13001693121131 SYRINGE in 1 CARTON (0169-3121-13) / 3 mL in 1 SYRINGE (0169-3121-01) 1 syringe2026-03-26NoNoCurrent