NDC 64380-765

Polyethylene Glycol 3350 and electrolytes - Unflavored

Polyethylene Glycol 3350 And Electrolytes - Unflavored

Polyethylene Glycol 3350 and electrolytes - 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 Sulfate Anhydrous; Sodium Bicarbonate; Sodium Chloride; Potassium Chlorate.

• Product ID: 64380-765_1ac8e92b-9eeb-4ec0-8d97-956450d94efe
• NDC: 64380-765
• Product Type: Human Prescription Drug
• Proprietary Name: Polyethylene Glycol 3350 and electrolytes - Unflavored
• Generic Name: Polyethylene Glycol 3350 And Electrolytes - Unflavored
• Dosage Form: Powder, For Solution
• Route of Administration: ORAL
• Marketing Start Date: 2019-01-10
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204558
• Labeler Name: Strides Pharma Science Limited
• Substance Name: POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORATE
• Active Ingredient Strength: 236 g/4L; g/4L; g/4L; g/4L; g/4L
• Pharm Classes: 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]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 64380-765-21

4 L in 1 JUG (64380-765-21)

• Marketing Start Date: 2019-01-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64380-765-21 [64380076521]

Polyethylene Glycol 3350 and electrolytes - Unflavored POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA204558
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-01-10

Drug Details

Active Ingredients

Ingredient	Strength
POLYETHYLENE GLYCOL 3350	236 g/4L

OpenFDA Data

• SPL SET ID: 48c741a9-9039-4fdb-a875-86d4ea968282
• Manufacturer:
  • Strides Pharma Science Limited
• UNII:
  • G2M7P15E5P
  • H35KS68EE7
  • 8MDF5V39QO
  • 451W47IQ8X
  • 36KCS0R750
  • 660YQ98I10
• RxNorm Concept Unique ID - RxCUI:
  • 966920

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]