polyethylene glycol 3350 and electrolytes - unflavored

Generic: polyethylene glycol 3350 and electrolytes - unflavored

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name polyethylene glycol 3350 and electrolytes - unflavored
Generic Name polyethylene glycol 3350 and electrolytes - unflavored
Labeler strides pharma science limited
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

polyethylene glycol 3350 236 g/4L, potassium chlorate 2.97 g/4L, sodium bicarbonate 6.74 g/4L, sodium chloride 5.86 g/4L, sodium sulfate anhydrous 22.74 g/4L

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-765
Product ID 64380-765_7a344db7-fc02-4e38-b674-edcfbcf38bbe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204558
Listing Expiration 2026-12-31
Marketing Start 2019-01-10

Pharmacologic Class

Established (EPC)
osmotic laxative [epc]
Mechanism of Action
osmotic activity [moa]
Physiologic Effect
stimulation large intestine fluid/electrolyte secretion [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64380765
Hyphenated Format 64380-765

Supplemental Identifiers

RxCUI
966920
UPC
0364380766216 0364380765219 0364380767213
UNII
H35KS68EE7 36KCS0R750 G2M7P15E5P 660YQ98I10 451W47IQ8X 8MDF5V39QO
NUI
N0000010288 N0000175811 N0000009871

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name polyethylene glycol 3350 and electrolytes - unflavored (source: ndc)
Generic Name polyethylene glycol 3350 and electrolytes - unflavored (source: ndc)
Application Number ANDA204558 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 236 g/4L
  • 2.97 g/4L
  • 6.74 g/4L
  • 5.86 g/4L
  • 22.74 g/4L
source: ndc
Packaging
  • 4 L in 1 JUG (64380-765-21)
source: ndc

Packages (1)

64380-765-21 4 L in 1 JUG (64380-765-21)

Ingredients (5)

polyethylene glycol 3350 (236 g/4L) potassium chlorate (2.97 g/4L) sodium bicarbonate (6.74 g/4L) sodium chloride (5.86 g/4L) sodium sulfate anhydrous (22.74 g/4L)

Linked Drug Pages (1)

Polyethylene Glycol 3350 and electrolytes - Unflavored, Polyethylene Glycol 3350 and electrolytes with Lemon Flavor, Polyethylene Glycol 3350 and electrolyteswith Orange Flavor ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7a344db7-fc02-4e38-b674-edcfbcf38bbe", "openfda": {"nui": ["N0000010288", "N0000175811", "N0000009871"], "upc": ["0364380766216", "0364380765219", "0364380767213"], "unii": ["H35KS68EE7", "36KCS0R750", "G2M7P15E5P", "660YQ98I10", "451W47IQ8X", "8MDF5V39QO"], "rxcui": ["966920"], "spl_set_id": ["48c741a9-9039-4fdb-a875-86d4ea968282"], "pharm_class_pe": ["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "pharm_class_epc": ["Osmotic Laxative [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 L in 1 JUG (64380-765-21)", "package_ndc": "64380-765-21", "marketing_start_date": "20190110"}], "brand_name": "Polyethylene Glycol 3350 and electrolytes - Unflavored", "product_id": "64380-765_7a344db7-fc02-4e38-b674-edcfbcf38bbe", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["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]"], "product_ndc": "64380-765", "generic_name": "Polyethylene Glycol 3350 and electrolytes - Unflavored", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Polyethylene Glycol 3350 and electrolytes - Unflavored", "active_ingredients": [{"name": "POLYETHYLENE GLYCOL 3350", "strength": "236 g/4L"}, {"name": "POTASSIUM CHLORATE", "strength": "2.97 g/4L"}, {"name": "SODIUM BICARBONATE", "strength": "6.74 g/4L"}, {"name": "SODIUM CHLORIDE", "strength": "5.86 g/4L"}, {"name": "SODIUM SULFATE ANHYDROUS", "strength": "22.74 g/4L"}], "application_number": "ANDA204558", "marketing_category": "ANDA", "marketing_start_date": "20190110", "listing_expiration_date": "20261231"}