NDC 52268-101

GoLYTELY

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

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

• Product ID: 52268-101_062f0a59-731c-4c94-ae5c-620df9e6f7f2
• NDC: 52268-101
• Product Type: Human Prescription Drug
• Proprietary Name: GoLYTELY
• Generic Name: Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride
• Dosage Form: Powder, For Solution
• Route of Administration: ORAL
• Marketing Start Date: 1984-07-13
• Marketing Category: NDA / NDA
• Application Number: NDA019011
• Labeler Name: Braintree Laboratories, Inc.
• Substance Name: POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE
• 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],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: 2019-12-31

Packaging

NDC 52268-101-01

4 L in 1 BOTTLE, PLASTIC (52268-101-01)

• Marketing Start Date: 1984-07-13
• Marketing End Date: 2022-10-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52268-101-01 [52268010101]

GoLYTELY POWDER, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA019011
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1984-07-13

Drug Details

Active Ingredients

Ingredient	Strength
POLYETHYLENE GLYCOL 3350	236 g/4L

OpenFDA Data

• SPL SET ID: 57d22b0b-1ae0-4203-babc-f3bac17bd1c9
• Manufacturer:
  • Braintree Laboratories, Inc.
• UNII:
  • 36KCS0R750
  • 8MDF5V39QO
  • G2M7P15E5P
  • 451W47IQ8X
  • 660YQ98I10
• RxNorm Concept Unique ID - RxCUI:
  • 966922
  • 1870431
  • 966920
  • 966916

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]
• 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

52268010101 GOLYTELY SOLUTION

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "GoLYTELY" or generic name "Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride"

NDC	Brand Name	Generic Name
52268-100	GoLYTELY	Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride
52268-101	GoLYTELY	Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride
52268-700	GoLYTELY	Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride
10572-100	PEG-3350 and Electrolytes	Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride
10572-101	PEG-3350 and Electrolytes	Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride