NDC 65162-271
Sulfamethoxazole and Trimethoprim 80 mg / 400 mg tablet
On the label: Amneal Pharmaceuticals.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Amneal Pharmaceuticals Private Limited | Ahmedabad, India | Makes it, tests it, packages it and labels it | No problems foundJul 19, 2024 · 6 inspections |
Recalls
- Aug 18, 2025 · Class II · Amneal Pharmaceuticals, LLC
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Lots: Lot a) AM240173, Exp Date 01/31/2027, AM240680, Exp Date 05/31/2027, AM 240921, Exp Date 06/30/2027, AM241191, Exp Date 08/31/2027. Lot b) AM240176, AM240177, Exp Date 01/31/2027, AM240301, AM240300, Exp Date 02/28/2027, AM240676, AM240677, Exp Date 04/30/2027, AM240678, AM240679, Exp Date 05/30/2… - Jun 2, 2025 · Class I · Amneal Pharmaceuticals, LLC
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Lots: Lot #s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027
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
- 80 mg / 400 mg
- Approval
- ANDA ANDA076899
- On the market since
- Feb 25, 2010
- Package NDCs
65162-271-0565162-271-1065162-271-1165162-271-50- Official label
- DailyMed (National Library of Medicine), updated Apr 2, 2026
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