NDC 10702-283

ColPrep Kit

Sodium Sulfate, Potassium Sulfate, And Magnesium Sulfate For Oral Solution

ColPrep Kit is a Oral Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Kvk-tech, Inc.. The primary component is Sodium Sulfate; Potassium Sulfate; Magnesium Sulfate.

• Product ID: 10702-283_767105a0-65a5-444a-989f-f766b0851c2a
• NDC: 10702-283
• Product Type: Human Prescription Drug
• Proprietary Name: ColPrep Kit
• Generic Name: Sodium Sulfate, Potassium Sulfate, And Magnesium Sulfate For Oral Solution
• Dosage Form: Powder, For Solution
• Route of Administration: ORAL
• Marketing Start Date: 2016-12-27
• Marketing Category: NDA / NDA
• Application Number: NDA204553
• Labeler Name: KVK-Tech, Inc.
• Substance Name: SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE
• Active Ingredient Strength: 18 g/22.7g; g/22.7g; g/22.7g
• Pharm Classes: Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 10702-283-23

2 BOTTLE, PLASTIC in 1 CARTON (10702-283-23) > 22.7 g in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2016-12-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10702-283-23 [10702028323]

ColPrep Kit POWDER, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA204553
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-12-27
• Marketing End Date: 2019-01-24

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM SULFATE	17.5 g/22.7g

OpenFDA Data

• SPL SET ID: bd9f13a9-0f13-4809-ad70-8f3cc2bd19bd
• Manufacturer:
  • KVK-Tech, Inc.
• UNII:
  • 1K573LC5TV
  • 0YPR65R21J
• RxNorm Concept Unique ID - RxCUI:
  • 1120068
  • 1001689
• UPC Code:
  • 0310702083233

Pharmacological Class

• Osmotic Laxative [EPC]
• Increased Large Intestinal Motility [PE]
• Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
• Osmotic Activity [MoA]
• Calculi Dissolution Agent [EPC]
• Magnesium Ion Exchange Activity [MoA]
• Osmotic Laxative [EPC]
• Osmotic Activity [MoA]
• Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]
• Increased Large Intestinal Motility [PE]
• Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
• Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]