NDC 67046-1683
divalproex sodium 250 mg tablet, delayed release
On the label: Coupler LLC. It's repackaged: Coupler LLC rebottles it from Bionpharma Inc.'s NDC 69452-434.
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
- Coupler LLC, West Chester, PA, 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
- 250 mg
- Approval
- ANDA ANDA078853
- On the market since
- Jul 6, 2026
- Package NDCs
67046-1683-3- Official label
- DailyMed (National Library of Medicine), updated Jul 6, 2026
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