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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204558-001 POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT FOR SOLUTION / ORAL AA 2018-12-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204558-001 AA
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A204558-001 POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT FOR SOLUTION / ORAL AA 2018-12-21 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A204558-001 AA 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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 SODIUM SULFATE ANHYDROUS 2.97 g/4L SODIUM BICARBONATE 6.74 g/4L SODIUM CHLORIDE 5.86 g/4L POTASSIUM CHLORIDE 22.74 g/4L
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 6 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 966920 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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