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Awiqli

Insulin icodec-abae · Injection, Solution

Prescription Biologic BLA

Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information.

Overview

Brand name

Awiqli

Generic name

Insulin icodec-abae

Dosage form

Injection, Solution

Route

Subcutaneous

Marketing category

BLA · BLA

Labeler

Novo Nordisk Pharmaceutical Industries, LP

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

Data completeness

52% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Insulin Icodec	700 U/mL	—	—

Forms, strengths and routes

Source: NDC Directory

Dosage form

Injection, Solution

Route of administration

Subcutaneous

Presentations

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

761326

Application type

BLA · Biologics License Application

Approval date

March 26, 2026

Sponsor

NOVO NORDISK INC

Products on application

Submissions recorded

Products approved under application 761326.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
761326-001	AWIQLI FLEXTOUCH	INJECTION		INSULIN ICODEC	Prescription	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 761326.
Type	No.	Action	Status	Date	Review
Original application	2	Type 1 - New Molecular Entity	Approved	March 26, 2026	Standard

Review documents

0 · Original application · June 22, 2026
0 · Original application · March 31, 2026
0 · Original application · March 31, 2026

Adverse event reports

Source: openFDA FAERS

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
0169-3105-11	0169-3105	Novo Nordisk Pharmaceutical Industries, LP	1 SYRINGE in 1 CARTON (0169-3105-11) / 1.5 mL in 1 SYRINGE (0169-3105-01)	August 3, 2026
0169-3170-97	0169-3170	Novo Nordisk Pharmaceutical Industries, LP	1 SYRINGE in 1 CARTON (0169-3170-97) / 1 mL in 1 SYRINGE (0169-3170-90)	August 11, 2026
0169-3105	0169-3105	Novo Nordisk Pharmaceutical Industries, LP	—	August 3, 2026
0169-3170	0169-3170	Novo Nordisk Pharmaceutical Industries, LP	—	August 11, 2026

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Purple Book	FDA	Biologic licence classification

Generated September 25, 2026 · 7 sections on this page.