NDC 64380-768

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

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

Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - Unflavored is a Oral Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Strides Pharma Science Limited. The primary component is Polyethylene Glycol 3350; Sodium Chloride; Sodium Bicarbonate; Potassium Chloride.

Product ID64380-768_3388589a-a0c6-4bd1-b706-a41f01f47f35
NDC64380-768
Product TypeHuman Prescription Drug
Proprietary NamePolyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - Unflavored
Generic NamePolyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride - Unflavored
Dosage FormPowder, For Solution
Route of AdministrationORAL
Marketing Start Date2015-04-14
Marketing CategoryANDA / ANDA
Application NumberANDA204559
Labeler NameStrides Pharma Science Limited
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 Through2020-12-31

Packaging

NDC 64380-768-21

4 L in 1 JUG (64380-768-21)
Marketing Start Date2015-04-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64380-768-21 [64380076821]

Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - Unflavored POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA204559
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-04-14

Drug Details

Active Ingredients

IngredientStrength
POLYETHYLENE GLYCOL 3350420 g/4L

OpenFDA Data

SPL SET ID:37c111ec-5b62-42b9-bbb2-3b0c530e34c9
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]

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