TriLyte

Product NDC

51525-6831

11-digit product format

515256831

Labeler code

51525

Product ID

51525-6831_71ee65e3-2a55-4fe4-bdad-cfbd4a8835a4

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Polyethylene glyocol 3350, sodium chloride, sodium bicarbonate and potassium chloride

Dosage form

POWDER, FOR SOLUTION

Route

NASOGASTRIC; ORAL

Labeler

Wallace Pharmaceuticals Inc.

Application

ANDA076491

Marketing category

ANDA

Marketing start

2016-10-01

Marketing end

2021-09-30

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

0000-00-00

Current FDA listing

Historical FDA.report record