NDC 61919-885
Fluoxetine 10 mg capsule
On the label: Direct Rx. It's repackaged: Direct Rx 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 |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Product details
- Generic drug
- Fluoxetine: every company that makes it
- Form
- capsule
- Strength
- 10 mg
- Approval
- ANDA ANDA078619
- On the market since
- Aug 1, 2019
- Package NDCs
61919-885-3061919-885-90- Official label
- DailyMed (National Library of Medicine), updated May 18, 2022
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