NDC 67046-145
Divalproex Sodium 250 mg tablet, delayed release
On the label: Coupler Enterprises Inc.. It's repackaged: Coupler Enterprises Inc. rebottles it from Caraco Pharmaceutical Laboratories, Ltd.'s NDC 62756-797.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited | Halol, India | Makes it and tests it | Serious problems, FDA actionJun 13, 2025 · 12 inspections, 5 with FDA action |
Repackaging site
- Coupler Enterprises, Location not on file · repackages it
Recalls
- Jun 27, 2022 · Class II · Sun Pharmaceutical Industries Inc
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Lots: Lot: HAC1312A, EXP. 05/2024
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, delayed release
- Strength
- 250 mg
- Approval
- ANDA ANDA078597
- On the market since
- Sep 21, 2017
- Package NDCs
67046-145-0767046-145-1467046-145-1567046-145-2067046-145-2167046-145-2867046-145-3067046-145-60- Official label
- DailyMed (National Library of Medicine), updated Sep 21, 2017
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