NDC 10572-400

PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride

Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride

PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride is a Oral Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Affordable Pharmaceuticals, Llc. The primary component is Polyethylene Glycol 3350; Sodium Chloride; Sodium Bicarbonate; Potassium Chloride.

Product ID10572-400_16fd321d-f891-4083-99f7-26e2e122619c
NDC10572-400
Product TypeHuman Prescription Drug
Proprietary NamePEG-3350, sodium chloride, sodium bicarbonate and potassium chloride
Generic NamePolyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride
Dosage FormPowder, For Solution
Route of AdministrationORAL
Marketing Start Date2013-02-08
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA019797
Labeler NameAffordable Pharmaceuticals, LLC
Substance NamePOLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE
Active Ingredient Strength420 g/4L; g/4L; g/4L; g/4L
Pharm ClassesOsmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 10572-400-01

4 L in 1 BOTTLE (10572-400-01)
Marketing Start Date2013-02-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10572-400-01 [10572040001]

PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride POWDER, FOR SOLUTION
Marketing CategoryNDA authorized generic
Application NumberNDA019797
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-02-08
Marketing End Date2016-07-31

Drug Details

Active Ingredients

IngredientStrength
POLYETHYLENE GLYCOL 3350420 g/4L

OpenFDA Data

SPL SET ID:6f0ccd73-bdc9-445e-8b5c-37eefb832903
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 801054
  • Pharmacological Class

    • Osmotic Activity [MoA]
    • Osmotic Laxative [EPC]
    • Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
    • Osmotic Laxative [EPC]
    • Increased Large Intestinal Motility [PE]
    • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
    • Osmotic Activity [MoA]
    • Osmotic Laxative [EPC]
    • Increased Large Intestinal Motility [PE]
    • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
    • Osmotic Activity [MoA]
    • Potassium Compounds [CS]
    • Potassium Salt [EPC]
    • Osmotic Laxative [EPC]
    • Increased Large Intestinal Motility [PE]
    • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
    • Osmotic Activity [MoA]

    Medicade Reported Pricing

    10572040001 PEG-3350 WITH FLAVOR PACKS SOL

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride" or generic name "Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride"

    NDCBrand NameGeneric Name
    10572-302PEG-3350, sodium chloride, sodium bicarbonate and potassium chloridepolyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride
    10572-400PEG-3350, sodium chloride, sodium bicarbonate and potassium chloridepolyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride

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