NDC 67046-2021
Divalproex Sodium 250 mg tablet, extended release
On the label: Coupler LLC. It's repackaged: Coupler LLC rebottles it from Dr.Reddy's Laboratories Ltd.'s NDC 55111-533.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Dr. Reddy's Laboratories Limited | Medchal-Malkajgiri, India | Makes it and tests it | Problems found, fixed voluntarilyOct 27, 2023 · 8 inspections |
Repackaging site
- Coupler LLC, West Chester, PA, United States · repackages it
Recalls
- Jan 31, 2019 · Class II · Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications: Out of specification results observed for high dissolution.
Lots: Lot #: C802676, Exp 03/20 - May 22, 2015 · Class II · Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Lots: 100 count bottle - Lot #C307859, exp 09/2015; 500 count bottle - Lot #C307859 and Lot# C307812, exp 09/2015
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
- 250 mg
- Approval
- ANDA ANDA090161
- On the market since
- Jun 1, 2026
- Package NDCs
67046-2021-3- Official label
- DailyMed (National Library of Medicine), updated Jun 1, 2026
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