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
Affordable Pharmaceuticals, LLC
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 )