polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride - unflavored

Generic: polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride - unflavored

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

Drug Facts

Product Profile

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

polyethylene glycol 3350 420 g/4L, potassium chloride 1.48 g/4L, sodium bicarbonate 5.72 g/4L, sodium chloride 11.2 g/4L

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-768
Product ID 64380-768_5ecacfb6-b0c7-4460-820c-9a4453dd16f5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204559
Listing Expiration 2026-12-31
Marketing Start 2015-04-14

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 64380768
Hyphenated Format 64380-768

Supplemental Identifiers

RxCUI
801054
UNII
660YQ98I10 G2M7P15E5P 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, sodium chloride, sodium bicarbonate and potassium chloride - unflavored (source: ndc)
Generic Name polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride - unflavored (source: ndc)
Application Number ANDA204559 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 420 g/4L
  • 1.48 g/4L
  • 5.72 g/4L
  • 11.2 g/4L
source: ndc
Packaging
  • 4 L in 1 JUG (64380-768-21)
source: ndc

Packages (1)

64380-768-21 4 L in 1 JUG (64380-768-21)

Ingredients (4)

polyethylene glycol 3350 (420 g/4L) potassium chloride (1.48 g/4L) sodium bicarbonate (5.72 g/4L) sodium chloride (11.2 g/4L)

Linked Drug Pages (1)

Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - Unflavored, Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride with Lemon Flavor, Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride with Orange Flavor ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5ecacfb6-b0c7-4460-820c-9a4453dd16f5", "openfda": {"nui": ["N0000010288", "N0000175811", "N0000009871"], "unii": ["660YQ98I10", "G2M7P15E5P", "451W47IQ8X", "8MDF5V39QO"], "rxcui": ["801054"], "spl_set_id": ["37c111ec-5b62-42b9-bbb2-3b0c530e34c9"], "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 (64380-768-21)", "package_ndc": "64380-768-21", "marketing_start_date": "20150414"}], "brand_name": "Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - Unflavored", "product_id": "64380-768_5ecacfb6-b0c7-4460-820c-9a4453dd16f5", "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": "64380-768", "generic_name": "Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - Unflavored", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - Unflavored", "active_ingredients": [{"name": "POLYETHYLENE GLYCOL 3350", "strength": "420 g/4L"}, {"name": "POTASSIUM CHLORIDE", "strength": "1.48 g/4L"}, {"name": "SODIUM BICARBONATE", "strength": "5.72 g/4L"}, {"name": "SODIUM CHLORIDE", "strength": "11.2 g/4L"}], "application_number": "ANDA204559", "marketing_category": "ANDA", "marketing_start_date": "20150414", "listing_expiration_date": "20261231"}