NDC 43386-050

GaviLyte - N

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

GaviLyte - N is a Oral Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Lupin Pharmaceuticals,inc.. The primary component is Polyethylene Glycol 3350; Sodium Chloride; Sodium Bicarbonate; Potassium Chloride.

• Product ID: 43386-050_3ff4d772-6527-4791-9236-e1a97878a200
• NDC: 43386-050
• Product Type: Human Prescription Drug
• Proprietary Name: GaviLyte - N
• Generic Name: Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride And Sodium Bicarbonate
• Dosage Form: Powder, For Solution
• Route of Administration: ORAL
• Marketing Start Date: 2009-05-28
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090019
• Labeler Name: Lupin Pharmaceuticals,Inc.
• Substance Name: POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE
• Active Ingredient Strength: 420 g/438.4g; g/438.4g; g/438.4g; g/438.4g
• 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],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 43386-050-19

438.4 g in 1 BOTTLE (43386-050-19)

• Marketing Start Date: 2009-05-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43386-050-19 [43386005019]

GaviLyte - N POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090019
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2009-05-28

Drug Details

Active Ingredients

Ingredient	Strength
POLYETHYLENE GLYCOL 3350	420 g/438.4g

OpenFDA Data

• SPL SET ID: 27195187-75a3-431f-90d9-84da1b94e849
• Manufacturer:
  • Lupin Pharmaceuticals,Inc.
• UNII:
  • 8MDF5V39QO
  • G2M7P15E5P
  • 451W47IQ8X
  • 660YQ98I10
• RxNorm Concept Unique ID - RxCUI:
  • 979099
  • 801054
• UPC Code:
  • 0343386050192
  • 0343386200023

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]
• 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]

Medicade Reported Pricing

43386050011 FAMOTIDINE 40 MG/5 ML SUSP

Pricing Unit: ML | Drug Type:

43386005019 GAVILYTE-N SOLUTION

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "GaviLyte - N" or generic name "Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride And Sodium Bicarbonate"

NDC	Brand Name	Generic Name
43386-050	GaviLyte - N	polyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonate
40032-050	Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride and Sodium Bicarbonate	Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride and Sodium Bicarbonate