NDC 72189-641
Ibuprofen Famotidine 800 mg / 26.6 mg tablet, film coated
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Ascend Laboratories, LLC's NDC 67877-626.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Alkem Laboratories Limited | Amaliya Daman, India | Makes it | No problems foundAug 30, 2019 · 6 inspections |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · relabels it
Recalls
- Dec 29, 2023 · Class II · Ascend Laboratories, LLC
Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Lots: 23140190, Exp. Date 12/31/2024
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Famotidine and Ibuprofen: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 800 mg / 26.6 mg
- Approval
- ANDA ANDA211890
- On the market since
- Sep 18, 2025
- Package NDCs
72189-641-90- Official label
- DailyMed (National Library of Medicine), updated Sep 18, 2025
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