NDC 0615-8334
Glimepiride 4 mg tablet
On the label: NCS HealthCare of KY, Inc dba Vangard Labs. It's repackaged: NCS HealthCare of KY, Inc dba Vangard Labs rebottles it from Micro Labs Limited's NDC 42571-103.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Micro Labs Limited | Verna, India | Makes it | Problems found, fixed voluntarilyMay 30, 2025 · 6 inspections, 1 with FDA action |
Repackaging site
- NCS HealthCare of KY, LLC dba Vangard Labs, Glasgow, KY, United States · repackages it
Recalls
- Oct 9, 2014 · Class II · Micro Labs Usa, Inc S
Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing.
Lots: GLBG001 Exp.12/14, GLBG008 Exp. 06/15
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Glimepiride: every company that makes it
- Form
- tablet, oral
- Strength
- 4 mg
- Approval
- ANDA ANDA091220
- On the market since
- Jun 13, 2013
- Package NDCs
0615-8334-39- Official label
- DailyMed (National Library of Medicine), updated Apr 30, 2020
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