Drugplain

Levemir 100 [iU]/mL

insulin detemir · INJECTION, SOLUTION · A-S Medication Solutions

2 Recalls on RecordCurrently in Shortage
Plain English

Levemir is a injection, solution containing insulin detemir at 100 [iU]/mL, taken subcutaneous. Manufactured by A-S Medication Solutions.

Key Facts

Brand Name
Levemir
Generic Name
insulin detemir
NDC Code (Product)
50090-1276
Manufacturer
A-S Medication Solutions
Strength
100 [iU]/mL
Dosage Form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Marketing Status
Application #
BLA021536
Drug Class
Insulin Analog [EPC]
Marketing Start
03/27/2006

Recall History

2 Recalls on Record
Class II12/22/2022

Pharmacy Innovations

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

TerminatedVoluntary: Firm initiated
Class I03/22/2021

Novo Nordisk Inc

Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

blood glucose increased6,225 reports
nausea2,000 reports
blood glucose decreased1,575 reports
fatigue1,548 reports
diarrhoea1,408 reports
drug ineffective1,367 reports
vomiting1,340 reports
dyspnoea1,298 reports
malaise1,217 reports
fall1,208 reports

Frequently Asked Questions

What is Levemir used for?

Levemir contains insulin detemir. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.

Is Levemir a controlled substance?

Levemir is not classified as a controlled substance by the DEA.

What is the generic name for Levemir?

The generic name for Levemir is insulin detemir. There are 1 other brand versions of insulin detemir.

What is the NDC code for Levemir 100 [iU]/mL?

The NDC (National Drug Code) for Levemir 100 [iU]/mL is 50090-1276, listed by A-S Medication Solutions.

Product NDC

50090-1276

Package NDC

50090-1276-0

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)