NDC 64380-770

Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride with Orange Flavor

Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride With Orange Flavor

Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride with Orange Flavor 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 ID64380-770_3388589a-a0c6-4bd1-b706-a41f01f47f35
NDC64380-770
Product TypeHuman Prescription Drug
Proprietary NamePolyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride with Orange Flavor
Generic NamePolyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride With Orange Flavor
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]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 64380-770-21

4 L in 1 JUG (64380-770-21)
Marketing Start Date2015-04-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64380-770-21 [64380077021]

Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride with Orange Flavor 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]

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