NDC 16590-648
Divalproex Sodiumdr 500 mg tablet, delayed release particles
On the label: Stat Rx USA. It's repackaged: Stat Rx USA rebottles it from Caraco Pharmaceutical Laboratories, Ltd.'s NDC 62756-798.
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 |
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 particles
- Strength
- 500 mg
- Approval
- ANDA ANDA078597
- On the market since
- Jul 29, 2008
- Package NDCs
16590-648-3016590-648-6016590-648-90- Official label
- DailyMed (National Library of Medicine), updated Mar 22, 2010
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?