Drugplain

INSULIN GLARGINE 100 [iU]/mL

insulin glargine-yfgn · INJECTION, SOLUTION · Civica, Inc.

3 Recalls on RecordCurrently in Shortage
Plain English

INSULIN GLARGINE is a injection, solution containing insulin glargine-yfgn at 100 [iU]/mL, taken subcutaneous. Manufactured by Civica, Inc..

Key Facts

Brand Name
INSULIN GLARGINE
Generic Name
insulin glargine-yfgn
NDC Code (Product)
72572-422
Manufacturer
Civica, Inc.
Strength
100 [iU]/mL
Dosage Form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Marketing Status
Application #
BLA761201
Drug Class
Insulin Analog [EPC]
Marketing Start
10/30/2025

Recall History

3 Recalls on Record
Class I04/12/2022

Mylan Pharmaceuticals Inc

Labeling: Missing label on the vial

TerminatedVoluntary: Firm initiated
Class I07/05/2022

Mylan Pharmaceuticals Inc

Labeling: Missing label: Label missing from some prefilled pens.

TerminatedVoluntary: Firm initiated
Class I01/05/2022

Mylan Pharmaceuticals Inc

Labeling: Missing Label: label missing from some Semglee prefilled pens.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

hypoglycaemia1,577 reports
blood glucose increased1,508 reports
acute kidney injury969 reports
dyspnoea951 reports
hyperglycaemia906 reports
nausea896 reports
drug ineffective858 reports
diarrhoea856 reports
off label use806 reports
vomiting794 reports

Frequently Asked Questions

What is INSULIN GLARGINE used for?

INSULIN GLARGINE contains insulin glargine-yfgn. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.

Is INSULIN GLARGINE a controlled substance?

INSULIN GLARGINE is not classified as a controlled substance by the DEA.

What is the generic name for INSULIN GLARGINE?

The generic name for INSULIN GLARGINE is insulin glargine-yfgn. There are 4 other brand versions of insulin glargine-yfgn.

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

The NDC (National Drug Code) for INSULIN GLARGINE 100 [iU]/mL is 72572-422, listed by Civica, Inc..

Product NDC

72572-422

Package NDC

72572-422-01

Other INSULIN GLARGINE Dosages

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

Data from openFDA · Public domain (CC0 1.0)