NDC 67046-146
Divalproex Sodium 500 mg tablet, extended release
On the label: Coupler Enterprises Inc.. It's repackaged: Coupler Enterprises Inc. rebottles it from Dr.Reddy's Laboratories Ltd.'s NDC 55111-534.
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 Enterprises, Location not on file · repackages it
Recalls
- May 22, 2015 · Class II · Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Lots: Lot #C308195, exp 10/2015
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
- Strength
- 500 mg
- Approval
- ANDA ANDA090070
- On the market since
- Oct 2, 2017
- Package NDCs
67046-146-0767046-146-1467046-146-1567046-146-2067046-146-2167046-146-2867046-146-3067046-146-60- Official label
- DailyMed (National Library of Medicine), updated Oct 2, 2017
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?