NDC 67046-213
Fluoxetine 20 mg capsule
On the label: Coupler Enterprises Inc.. It's repackaged: Coupler Enterprises Inc. rebottles it from Aurobindo Pharma Limited's NDC 65862-193.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Apl Healthcare Limited | Tirupati, India | Makes it and tests it | Problems found, fixed voluntarilyDec 17, 2025 · 5 inspections |
| Aurobindo Pharma Limited | Medchal, India | Makes it and tests it | Problems found, fixed voluntarilyJul 21, 2023 · 13 inspections, 1 with FDA action |
| Aurobindo Pharma Limited | Mahabubnagar, India | Makes it and tests it | Problems found, fixed voluntarilyMay 10, 2022 · 7 inspections, 1 with FDA action |
Repackaging site
- Coupler Enterprises, Location not on file · repackages it
Product details
- Generic drug
- Fluoxetine: every company that makes it
- Form
- capsule
- Strength
- 20 mg
- Approval
- ANDA ANDA078619
- On the market since
- Sep 19, 2017
- Package NDCs
67046-213-0767046-213-1467046-213-1567046-213-2167046-213-2867046-213-3067046-213-60- Official label
- DailyMed (National Library of Medicine), updated Dec 19, 2018
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