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Prescription medicine

Insulin detemir

Brand names: Levemir

Drug class: Insulin Analog

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
0Recalls (FDA reports)
1Companies
2005First FDA approval on file

Quick answers

What is Insulin detemir used for?
The FDA-approved label (Levemir, A-S Medication Solutions, October 9, 2024) says: “LEVEMIR is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use LEVEMIR is not recommended for the treatment of diabetic ketoacidosis. LEVEMIR is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use: Not recommended for the treatment of diabetic ketoacidosis.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Insulin detemir have a boxed warning?
No. None of the 1 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Insulin detemir?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Insulin detemir been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Insulin detemir?
1 company lists prescription products of Insulin detemir in the FDA NDC Directory, including A-S Medication Solutions.

What Insulin detemir is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

LEVEMIR is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use LEVEMIR is not recommended for the treatment of diabetic ketoacidosis. LEVEMIR is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use: Not recommended for the treatment of diabetic ketoacidosis.

— FDA label: Levemir, A-S Medication Solutions, effective October 9, 2024. Read the full label on DailyMed →

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Diabetes

Related medical specialties

Endocrinology

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

Forms and how it is given

Dosage formsInjection, solution
RouteSubcutaneous
Prescription products1 in the FDA NDC Directory
Brand namesLevemir

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
BLA021536
LEVEMIR, LEVEMIR FLEXPEN, LEVEMIR FLEXTOUCH, LEVEMIR INNOLET, LEVEMIR PENFILL		 Novo Nordisk IncJune 16, 2005 27, latest December 8, 2022
2022: Labeling · 2022: Labeling · 2019: Labeling

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

RxCUI (RxNorm)484322, 616238, 847239, 847241
SPL set ID of the quoted label82192527-99aa-4b53-8ce9-9173668d309c
FDA labels (SPL)1
FDA applicationsBLA021536
Active ingredients (FDA)INSULIN DETEMIR

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Levemir, A-S Medication Solutions, effective October 9, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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