NDC 67046-0539
Olanzapine 2.5 mg tablet, film coated
On the label: Coupler LLC. It's repackaged: Coupler LLC rebottles it from Dr.Reddy's Laboratories Ltd.'s NDC 55111-163.
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 LLC, West Chester, PA, United States · repackages it
Recalls
- Oct 13, 2016 · Class III · Dr. Reddy's Laboratories, Inc.
Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.
Lots: C500202
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Olanzapine: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 2.5 mg
- Approval
- ANDA ANDA076255
- On the market since
- May 13, 2026
- Package NDCs
67046-0539-3- Official label
- DailyMed (National Library of Medicine), updated May 13, 2026
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