Quick answers
- What is Gavilyte-N?
- Gavilyte-N is a brand name of Polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride, a prescription medicine. The FDA NDC Directory lists 1 Gavilyte-N product in 1 strength and form.
- Who makes Gavilyte-N?
- Novel Labs Inc holds the FDA application for Gavilyte-N (ANDA090019, approved May 27, 2009).
- Is there a generic or store brand of Gavilyte-N?
- Other products of Polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride are listed with the FDA, but none in exactly the same strength and form as a Gavilyte-N product.
- What do pharmacies pay for Gavilyte-N?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 1 Gavilyte-N strength and form (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
- Has Gavilyte-N been recalled?
- FDA enforcement reports list 1 recall of Gavilyte-N products; the newest started March 19, 2019. A recall usually concerns specific lots, not every product.
What Gavilyte-N is
Each Gavilyte-N 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/438.4 g · potassium chloride 1.48 g/438.4 g · sodium bicarbonate 5.72 g/438.4 g · sodium chloride 11.2 g/438.4 g powder, for solution (oral) | Gavilyte-N | None listed | 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 |
|---|---|---|---|
| ANDA090019 | Novel Labs Inc | May 27, 2009 | 1 |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| polyethylene glycol 3350 420 g/438.4 g · potassium chloride 1.48 g/438.4 g · sodium bicarbonate 5.72 g/438.4 g · sodium chloride 11.2 g/438.4 g powder, for solution | Generic: Gavilyte-N | $0.0043 per mL Generic of the same strength and form: $0.0043 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list Gavilyte-N
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Gavilyte-N products.
- Lupin Pharmaceuticals, Inc.1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 19, 2019 · Class II · Terminated · D-1113-2019
Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for Lupin Pharmaceuticals, Inc. Baltim — LUPIN SOMERSET
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.