NDC 72189-312
Emtricitabine And Tenofovir Disoproxil Fumarate 200 mg / 300 mg tablet, film coated
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-287.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Salcette, India | Makes it and packages it | Problems found, fixed voluntarilyNov 21, 2025 · 9 inspections, 1 with FDA action |
| Lupin Limited | Nagpur, India | Makes it and packages it | Problems found, fixed voluntarilyJul 11, 2023 · 4 inspections |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · relabels it
Product details
- Generic drug
- Emtricitabine and Tenofovir: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 200 mg / 300 mg
- Approval
- ANDA ANDA204131
- On the market since
- Jan 26, 2022
- Package NDCs
72189-312-03- Official label
- DailyMed (National Library of Medicine), updated Jan 21, 2025
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