NDC 43386-060

GaviLyte - C TM

Polyethylene Glycol-3350 And Electrolytes With Flavor Pack

GaviLyte - C TM 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; Potassium Chloride; Sodium Bicarbonate; Sodium Sulfate Anhydrous.

• Product ID: 43386-060_7af81acb-3c86-4089-93dc-2cf9a6fac42a
• NDC: 43386-060
• Product Type: Human Prescription Drug
• Proprietary Name: GaviLyte - C TM
• Generic Name: Polyethylene Glycol-3350 And Electrolytes With Flavor Pack
• Dosage Form: Powder, For Solution
• Route of Administration: ORAL
• Marketing Start Date: 2009-01-06
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090186
• Labeler Name: Lupin Pharmaceuticals,Inc.
• Substance Name: POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM SULFATE ANHYDROUS
• Active Ingredient Strength: 240 g/278.26g; g/278.26g; g/278.26g; g/278.26g; g/278.26g
• Pharm Classes: Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],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 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 43386-060-19

278.26 g in 1 BOTTLE (43386-060-19)

• Marketing Start Date: 2009-06-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43386-060-19 [43386006019]

GaviLyte - C TM POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090186
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2009-06-01

Drug Details

Active Ingredients

Ingredient	Strength
POLYETHYLENE GLYCOL 3350	240 g/278.26g

OpenFDA Data

• SPL SET ID: a8b15625-ca7c-4d57-9f36-3ac2a6d13665
• Manufacturer:
  • Lupin Pharmaceuticals,Inc.
• UNII:
  • 8MDF5V39QO
  • 36KCS0R750
  • G2M7P15E5P
  • 451W47IQ8X
  • 660YQ98I10
• RxNorm Concept Unique ID - RxCUI:
  • 967023
  • 966914
• UPC Code:
  • 0343386204021
  • 0343386060191

Pharmacological Class

• Osmotic Activity [MoA]
• Osmotic Laxative [EPC]
• Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
• 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 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]
• 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 Laxative [EPC]
• Increased Large Intestinal Motility [PE]
• Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
• Osmotic Activity [MoA]

Medicade Reported Pricing

43386006019 GAVILYTE-C SOLUTION

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "GaviLyte - C TM" or generic name "Polyethylene Glycol-3350 And Electrolytes With Flavor Pack"

NDC	Brand Name	Generic Name
43386-060	GaviLyte - C	polyethylene glycol-3350 and electrolytes with Flavor Pack
40032-060	Polyethylene Glycol-3350 and Electrolytes with Flavor Pack	Polyethylene Glycol-3350 and Electrolytes with Flavor Pack