polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride

FDA Drug Profile — PEG 3350, sodium chloride, sodium bicarbonate and potassium chloride, PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride

polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand names including PEG 3350, sodium chloride, sodium bicarbonate and potassium chloride, PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride. Available dosage form: powder, for solution.

Drug Details

Generic Name
polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride
Brand Names
PEG 3350, sodium chloride, sodium bicarbonate and potassium chloride, PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride
Application Number
NDA019797
Sponsor
Wilshire Pharmaceuticals, Inc.
NDC Codes
2
Dosage Forms
POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients
POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater. PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy in adults and pediatric patients aged 6 months or greater ( 1 )