NDC 53489-146
Sulfamethoxazole and Trimethoprim 160 mg / 800 mg tablet
On the label: Caraco Pharmaceutical Laboratories, Ltd..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| ALKALOIDA Vegyeszeti Gyar zartkoruen mukodo Reszvenytarsasag | Tiszavasvari, Hungary | Makes it, tests it and packages it | Problems found, fixed voluntarilyMar 12, 2025 · 6 inspections |
| Frontida BioPharm, LLC | Philadelphia, PA, United States | Makes it, tests it and packages it | No problems foundApr 2, 2026 · 10 inspections, 1 with FDA action |
Recalls
- Apr 19, 2018 · Class II · Sun Pharmaceutical Industries, Inc.
Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter identified as polyethylene was detected in two (2) tablets.
Lots: Lot 6848501, EXP 04/2020
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Sulfamethoxazole and Trimethoprim: every company that makes it
- Form
- tablet, oral
- Strength
- 160 mg / 800 mg
- Approval
- ANDA ANDA071017
- On the market since
- Aug 25, 1986
- Package NDCs
53489-146-0153489-146-05- Official label
- DailyMed (National Library of Medicine), updated Apr 3, 2025
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