NDC 0615-8586
divalproex sodium 125 mg tablet, delayed release
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 Bionpharma Inc.'s NDC 69452-433.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| OrBion Pharmaceuticals Private Limited | Kancheepuram, India | Makes it, tests it, packages it and labels it | No problems foundOct 27, 2025 · 6 inspections |
Repackaging site
- NCS HealthCare of KY, LLC dba Vangard Labs, Glasgow, KY, United States · repackages it
Recalls
- Jun 26, 2026 · Class II · Bionpharma Inc.
Presence of Foreign Tablets/Capsules
Lots: Lot# 704C003, Exp. 12/31/2028
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Valproic Acid: every company that makes it
- Form
- tablet, delayed release, oral
- Strength
- 125 mg
- Approval
- ANDA ANDA078853
- On the market since
- Jun 26, 2024
- Package NDCs
0615-8586-39- Official label
- DailyMed (National Library of Medicine), updated Nov 14, 2025
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