NDC 43386-050
Gavilyte-N 4 ingredients powder, for solution
On the label: Lupin Pharmaceuticals, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Novel Laboratories, Inc. | Somerset, NJ, United States | Makes it, tests it and packages it | Problems found, fixed voluntarilyApr 17, 2026 · 15 inspections, 1 with FDA action |
Recalls
- Mar 19, 2019 · Class II · Lupin Somerset
Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
Lots: Lot #: a) S800021, Exp 30-Nov-20; b) S800175, Exp 31-Dec-20; c) S 800401, Exp 28-Feb-21; S800426, Exp 31-Mar-21; S800920, Exp 31-Aug-21.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride and Sodium Bicarbo: every company that makes it
- Form
- powder, for solution, oral
- Strength
- 4 ingredients
- Approval
- ANDA ANDA090019
- On the market since
- May 28, 2009
- Package NDCs
43386-050-19- Official label
- DailyMed (National Library of Medicine), updated Sep 10, 2025
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