NDC 50090-4187
Divalproex Sodium 500 mg tablet, extended release
On the label: A-S Medication Solutions. It's repackaged: A-S Medication Solutions 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
- A-S Medication Solutions LLC, Libertyville, IL, United States · repackages it and relabels 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
- Aug 11, 2013
- Package NDCs
50090-4187-0- Official label
- DailyMed (National Library of Medicine), updated May 31, 2019
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