Polyethylene Glycol 3350

Product NDC
68788-8601
11-digit product format
687888601
Labeler code
68788
Product ID
68788-8601_d2d91839-3b01-46e4-9203-b5a2afb49803
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA214990
Marketing category
ANDA
Marketing start
2024-03-08
Substance
POLYETHYLENE GLYCOL 3350
Active strength
17 g/17g
Pharmacologic classes
Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
G2M7P15E5PPOLYETHYLENE GLYCOL 335025322-68-3POLYETHYLENE GLYCOL 3350

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8601-268788860102238 g in 1 BOTTLE (68788-8601-2) 238 g2024-03-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Polyethylene Glycol 3350 Powder for Oral Solution, 17 gPreferred Pharmaceuticals Inc.2025-09-09HUMAN OTC DRUG LABEL2