NDC 65162-757
Divalproex Sodium 500 mg tablet, extended release
On the label: Amneal Pharmaceuticals.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Amneal Pharmaceuticals Private Limited | Ahmedabad, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyJan 24, 2025 · 9 inspections |
Recalls
- Dec 26, 2023 · Class II · Amneal Pharmaceuticals of New York, LLC
Failed dissolution specifications
Lots: Lot # AR210704, exp. date 04/2024 AR210706, exp. date 04/2024 AR210707, exp. date 04/2024 AR210708, exp. date 04/2024 AR210709, exp. date 04/2024 - Jul 27, 2022 · Class II · Amneal Pharmaceuticals of New York, LLC
Failed dissolution specifications.
Lots: Lot #: AR210705, Exp 04/2024
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, extended release, oral
- Strength
- 500 mg
- Approval
- ANDA ANDA203730
- On the market since
- Jun 1, 2015
- Package NDCs
65162-757-1065162-757-50- Official label
- DailyMed (National Library of Medicine), updated Apr 4, 2026
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