PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride

Product NDC

10572-400

11-digit product format

105720400

Labeler code

10572

Product ID

10572-400_16fd321d-f891-4083-99f7-26e2e122619c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

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

Dosage form

POWDER, FOR SOLUTION

Route

ORAL

Labeler

Affordable Pharmaceuticals, LLC

Application

NDA019797

Marketing category

NDA AUTHORIZED GENERIC

Marketing start

2013-02-08

Marketing end

0000-00-00

Substance

POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE

Active strength

420 g/4L; g/4L; g/4L; g/4L

Pharmacologic classes

Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record