NDC 61919-809
Divalproex Sodium 250 mg tablet, delayed release
On the label: Direct Rx. It's repackaged: Direct Rx 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
- Direct Rx, Dawsonville, GA, United States · repackages it and relabels 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
- Jan 1, 2015
- Package NDCs
61919-809-60- Official label
- DailyMed (National Library of Medicine), updated Aug 11, 2015
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