Home NDC 64380-767 Polyethylene Glycol 3350 and electrolyteswith Orange Flavor
Product NDC 64380-767
11-digit product format 643800767
Labeler code 64380
Product ID 64380-767_7a344db7-fc02-4e38-b674-edcfbcf38bbe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Polyethylene Glycol 3350 and electrolytes with Orange Flavor
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA204558
Marketing category ANDA
Marketing start 2019-01-10
Substance POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
Active strength 236; 2.97; 6.74; 5.86; 22.74 g/4L; g/4L; g/4L; g/4L; g/4L
Pharmacologic classes Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Polyethylene Glycol 3350 and electrolyteswith Orange Flavor
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POLYETHYLENE GLYCOL 3350 236 g/4L POTASSIUM CHLORIDE 2.97 g/4L SODIUM BICARBONATE 6.74 g/4L SODIUM CHLORIDE 5.86 g/4L SODIUM SULFATE ANHYDROUS 22.74 g/4L
Harmonized Identifiers# Field, Values table Field Values Unii 660YQ98I10, 36KCS0R750, 8MDF5V39QO, G2M7P15E5P, 451W47IQ8X, H35KS68EE7 Rxcui 966920
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64380-767-21 Polyethylene Glycol 3350 and electrolyteswith Orange Flavor 4 L in 1 JUG POWDER, FOR SOLUTION 4 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-767 POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES - UNFLAVORED POWDER, FOR SOLUTION POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES WITH LEMON FLAVOR POWDER, FOR SOLUTION POLYETHYLENE GLYCOL 3350 AND ELECTROLYTESWITH ORANGE FLAVOR (POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES WITH ORANGE FLAVOR) POWDER, FOR SOLUTION [STRIDES PHARMA SCIENCE LIMITED] 7 Current NDC, Legacy NDC, 1 package rows 20240524_48c741a9-9039-4fdb-a875-86d4ea968282.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64380-767-21 64380076721 4 L in 1 JUG (64380-767-21) 4 l 2019-01-10 0000-00-00 No No Current