NDC 40032-050

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

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

Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride and Sodium Bicarbonate is a Oral Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Novel Laboratories, Inc.. The primary component is Polyethylene Glycol 3350; Sodium Chloride; Sodium Bicarbonate; Potassium Chloride.

Product ID40032-050_0cb089b8-0127-4f5f-8b8d-77bc93409747
NDC40032-050
Product TypeHuman Prescription Drug
Proprietary NamePolyethylene Glycol-3350, Sodium Chloride, Potassium Chloride and Sodium Bicarbonate
Generic NamePolyethylene Glycol-3350, Sodium Chloride, Potassium Chloride And Sodium Bicarbonate
Dosage FormPowder, For Solution
Route of AdministrationORAL
Marketing Start Date2009-05-28
Marketing CategoryANDA / ANDA
Application NumberANDA090019
Labeler NameNovel Laboratories, Inc.
Substance NamePOLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE
Active Ingredient Strength420 g/438.4g; g/438.4g; g/438.4g; g/438.4g
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],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 FlagE
Listing Certified Through2017-12-31

Packaging

NDC 40032-050-19

438.4 g in 1 BOTTLE (40032-050-19)
Marketing Start Date2009-05-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 40032-050-19 [40032005019]

Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride and Sodium Bicarbonate POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA090019
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-05-28
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
POLYETHYLENE GLYCOL 3350420 g/438.4g

OpenFDA Data

SPL SET ID:444c83ae-ac3a-467c-be05-e2bcbfbaaba1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 801054
  • UPC Code
  • 0340032050193
  • 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]
    • 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 Crossover Matching brand name "Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride and Sodium Bicarbonate" or generic name "Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride And Sodium Bicarbonate"

    NDCBrand NameGeneric Name
    40032-050Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride and Sodium BicarbonatePolyethylene Glycol-3350, Sodium Chloride, Potassium Chloride and Sodium Bicarbonate
    43386-050GaviLyte - Npolyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonate

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