Clenpiq Liquid
NDC 55566-6800

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 55566-6800?
  5. Clenpiq Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) is a NDA-approved product labeled by Ferring Pharmaceuticals Inc.. Sodium picosulfate/magnesium oxide/citric acid solution is used to clean out the intestines before surgery or certain procedures (such as colonoscopy, X-rays). It is supplied as a liquid for oral administration. This product entry covers the primary NDC 55566-6800 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
55566-6800
Proprietary Name:
Clenpiq
Non-Proprietary Name: [1]
Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid
Substance Name: [2]
Anhydrous Citric Acid; Magnesium Oxide; Sodium Picosulfate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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Clinical Specifications

Dosage Form:
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Ferring Pharmaceuticals Inc.
Labeler Code:
55566
Product Label ID:
e95fff66-4ec0-4001-a727-33e66a5ec7d5
FDA Application Number: [6]
NDA209589
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
03-29-2023
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Product Characteristics

Flavor(s):

Code Structure Chart

Product Details

What is NDC 55566-6800?

The NDC code 55566-6800 is assigned by the FDA to the product Clenpiq. It is commonly known by its generic name, sodium picosulfate, magnesium oxide, and anhydrous citric acid. This pharmaceutical product is labeled by Ferring Pharmaceuticals Inc. and is currently categorized as listed product. The medication is a liquid administered via oral route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 55566-6800-1, 55566-6800-2. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Sodium picosulfate/magnesium oxide/citric acid solution is used to clean out the intestines before surgery or certain procedures (such as colonoscopy, X-rays). It is a laxative that works by drawing large amounts of water into your intestines and stimulating the colon. This causes watery bowel movements (diarrhea). Clearing stool from the intestines helps your doctor to better examine the inside of your colon.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ANHYDROUS CITRIC ACID 12 g/175mL - A key intermediate in metabolism. It is an acid compound found in citrus fruits. The salts of citric acid (citrates) can be used as anticoagulants due to their calcium chelating ability.
  • MAGNESIUM OXIDE 3.5 g/175mL - Magnesium oxide (MgO). An inorganic compound that occurs in nature as the mineral periclase. In aqueous media combines quickly with water to form magnesium hydroxide. It is used as an antacid and mild laxative and has many nonmedicinal uses.
  • SODIUM PICOSULFATE 10 mg/175mL

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 2626364 - citric acid 12 GM / magnesium oxide 3.5 GM / picosulfate sodium 10 MG in 175 mL Oral Solution
  • RxCUI: 2626364 - citric acid 68.6 MG/ML / magnesium oxide 20 MG/ML / picosulfate sodium 0.0571 MG/ML Oral Solution
  • RxCUI: 2626364 - citric acid 12 GM / magnesium oxide 3.5 GM / picosulfate sodium 10 MG per 175 ML Oral Solution
  • RxCUI: 2626366 - CLENPIQ 10 MG / 3.5 GM / 12 GM in 175 mL Oral Solution
  • RxCUI: 2626366 - citric acid 68.6 MG/ML / magnesium oxide 20 MG/ML / picosulfate sodium 0.0571 MG/ML Oral Solution [Clenpiq]

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Sodium Picosulfate, Magnesium Oxide, and Anhydrous Citric Acid


Sodium picosulfate, magnesium oxide, and anhydrous citric acid is used in adults and children 9 years of age and older to empty the colon (large intestine, bowel) before a colonoscopy (examination of the inside of the colon to check for colon cancer and other abnormalities) so that the doctor will have a clear view of the walls of the colon. Sodium picosulfate is in a class of medications called stimulant laxatives. Magnesium oxide and anhydrous citric acid combine to form a medication called magnesium citrate. Magnesium citrate is in a class of medications called osmotic laxatives. These medications work by causing watery diarrhea so that the stool can be emptied from the colon.
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* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".