NDC 43386-090

GAVILYTE G TM

Polyethylene Glycol-3350 And Electrolytes

GAVILYTE G 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 Bicarbonate; Sodium Chloride; Potassium Chloride; Sodium Sulfate Anhydrous.

• Product ID: 43386-090_0fbce211-aeda-410d-94ed-4d926273fed5
• NDC: 43386-090
• Product Type: Human Prescription Drug
• Proprietary Name: GAVILYTE G TM
• Generic Name: Polyethylene Glycol-3350 And Electrolytes
• Dosage Form: Powder, For Solution
• Route of Administration: ORAL
• Marketing Start Date: 2009-06-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090231
• Labeler Name: Lupin Pharmaceuticals,Inc.
• Substance Name: POLYETHYLENE GLYCOL 3350; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
• Active Ingredient Strength: 236 g/274.31g; g/274.31g; g/274.31g; g/274.31g; g/274.31g
• 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],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 43386-090-19

274.31 g in 1 BOTTLE (43386-090-19)

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

NDC SPL Data Element Entries

NDC 43386-090-19 [43386009019]

GAVILYTE G TM POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090231
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2009-06-01
• Inactivation Date: 2019-10-21
• Reactivation Date: 2019-10-28

NDC 43386-090-91 [43386009091]

GAVILYTE G TM POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090231
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-06-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
POLYETHYLENE GLYCOL 3350	236 g/274.31g

OpenFDA Data

• SPL SET ID: 3978822b-6473-4072-9f80-20ceb9bea355
• Manufacturer:
  • GAVIS Pharmaceuticals, LLC
• UNII:
  • 8MDF5V39QO
  • 36KCS0R750
  • G2M7P15E5P
  • 451W47IQ8X
  • 660YQ98I10
• RxNorm Concept Unique ID - RxCUI:
  • 966920
  • 967012

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

Medicade Reported Pricing

43386009019 GAVILYTE-G SOLUTION

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "GAVILYTE G TM" or generic name "Polyethylene Glycol-3350 And Electrolytes"

NDC	Brand Name	Generic Name
43386-090	GAVILYTE G	polyethylene glycol-3350 and Electrolytes
40032-090	POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES	POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES