Quick answers
- What is Trilyte?
- Trilyte is a brand name of Polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride, a prescription medicine. The FDA NDC Directory lists 1 Trilyte product in 1 strength and form.
- Who makes Trilyte?
- Aurobindo Pharma USA holds the FDA application for Trilyte (ANDA076491, approved February 5, 2004).
- Is there a generic or store brand of Trilyte?
- Yes. The FDA NDC Directory lists 5 other products with the same active ingredients, strength and form as a Trilyte product, 5 of them generic. Ask your pharmacist whether one is right for you.
- Has Trilyte been recalled?
- No recall linked to Trilyte products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Trilyte is
Each Trilyte product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| polyethylene glycol 3350 420 g/4 L · potassium chloride 1.48 g/4 L · sodium bicarbonate 5.72 g/4 L · sodium chloride 11.2 g/4 L powder, for solution (oral) | Trilyte | 5 products, 3 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride →
FDA approval
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| ANDA076491 | Aurobindo Pharma USA | February 5, 2004 | 1 |
Companies that list Trilyte
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Trilyte products.
- Aurobindo Pharma Limited1 product
Recalls
No recall linked to Trilyte products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.