NDC 61919-463
Ibuprofen 800 mg tablet, film coated
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Ascend Laboratories, LLC's NDC 67877-321.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Granules India Limited | Medchal-Malkajgiri District, India | Makes it | Problems found, fixed voluntarilyFeb 14, 2020 · 6 inspections |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Product details
- Generic drug
- Ibuprofen: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 800 mg
- Approval
- ANDA ANDA091625
- On the market since
- Aug 22, 2019
- Package NDCs
61919-463-1561919-463-2161919-463-4061919-463-4561919-463-6061919-463-7161919-463-7261919-463-90- Official label
- DailyMed (National Library of Medicine), updated Mar 5, 2026
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