NDC 0904-7345
Fluoxetine 10 mg capsule
On the label: Major Pharmaceuticals. It's repackaged: Major Pharmaceuticals rebottles it from Aurobindo Pharma Limited's NDC 65862-192.
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 |
Product details
- Generic drug
- Fluoxetine: every company that makes it
- Form
- capsule, oral
- Strength
- 10 mg
- Approval
- ANDA ANDA078619
- On the market since
- Jan 3, 2025
- Package NDCs
0904-7345-61- Official label
- DailyMed (National Library of Medicine), updated Aug 31, 2026
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