NDC 0037-6820

COLYTE

Peg-3350 And Electrolytes

COLYTE is a Nasogastric Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Meda Pharmaceuticals. The primary component is Polyethylene Glycol 3350; Sodium Chloride; Potassium Chloride; Sodium Bicarbonate; Sodium Sulfate.

• Product ID: 0037-6820_2686395b-421d-4c35-b201-74d133730afc
• NDC: 0037-6820
• Product Type: Human Prescription Drug
• Proprietary Name: COLYTE
• Generic Name: Peg-3350 And Electrolytes
• Dosage Form: Powder, For Solution
• Route of Administration: NASOGASTRIC
• Marketing Start Date: 2014-08-05
• Marketing End Date: 2021-09-30
• Marketing Category: NDA / NDA
• Application Number: NDA018983
• Labeler Name: Meda Pharmaceuticals
• Substance Name: POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM SULFATE
• Active Ingredient Strength: 240 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],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

Packaging

NDC 0037-6820-04

4 L in 1 BOTTLE (0037-6820-04)

• Marketing Start Date: 2014-08-05
• Marketing End Date: 2021-09-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0037-6820-04 [00037682004]

COLYTE POWDER, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA018983
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-08-05
• Marketing End Date: 2021-09-30

Drug Details

Active Ingredients

Ingredient	Strength
POLYETHYLENE GLYCOL 3350	240 g/4L

OpenFDA Data

• SPL SET ID: ad34d2e1-1e98-11e4-8c21-0800200c9a66
• Manufacturer:
  • Meda Pharmaceuticals
• UNII:
  • 8MDF5V39QO
  • 0YPR65R21J
  • G2M7P15E5P
  • 451W47IQ8X
  • 660YQ98I10
• RxNorm Concept Unique ID - RxCUI:
  • 967014
  • 966914

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]