NDC 67046-147
Divalproex Sodium 250 mg tablet, delayed release
On the label: Coupler Enterprises Inc.. It's repackaged: Coupler Enterprises Inc. rebottles it from Unichem Pharmaceuticals (USA), Inc.'s NDC 29300-139.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Unichem Laboratories Limited | Ghaziabad, India | Makes it, tests it, packages it and labels it | No problems foundFeb 13, 2024 · 7 inspections |
Repackaging site
- Coupler Enterprises, Location not on file · repackages it
Recalls
- Dec 19, 2017 · Class II · Unichem Pharmaceuticals Usa Inc
Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
Lots: Lot: ZDPH17040
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 ANDA079163
- On the market since
- Sep 25, 2017
- Package NDCs
67046-147-0767046-147-1467046-147-1567046-147-2067046-147-2167046-147-2867046-147-3067046-147-60- Official label
- DailyMed (National Library of Medicine), updated Sep 25, 2017
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