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  4. NDC Product Code: 31722-874 Sodium Picosulfate, Magnesium Oxide And Anhydrous Citric Acid

NDC 31722-874 Sodium Picosulfate, Magnesium Oxide And Anhydrous Citric Acid

Powder, Metered Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 31722-874?
  5. Sodium Picosulfate, Magnesium Oxide And Anhydrous Citric Acid 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

NDC Product Code:
31722-874
Proprietary Name:
Sodium Picosulfate, Magnesium Oxide And Anhydrous Citric Acid
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
Dosage Form:
Powder, Metered - An powder dosage form that is situated inside a container that has a mechanism to deliver a specified quantity.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Camber Pharmaceuticals, Inc.
    Labeler Code:
    31722
    Product Label ID:
    b759dc12-2dc1-4ef4-a375-1a61630d54d6
    FDA Application Number: [6]
    ANDA212789
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    07-18-2022
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Flavor(s):
    ORANGE (C73406)

    Code Structure Chart

    Product Details

    What is NDC 31722-874?

    The NDC code 31722-874 is assigned by the FDA to the product Sodium Picosulfate, Magnesium Oxide And Anhydrous Citric Acid which is a human prescription drug product labeled by Camber Pharmaceuticals, Inc.. The product's dosage form is powder, metered and is administered via oral form. The product is distributed in a single package with assigned NDC code 31722-874-16 2 packet in 1 carton / 16.1 g in 1 packet. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Sodium Picosulfate, Magnesium Oxide And Anhydrous Citric Acid?

    Sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older.

    What are Sodium Picosulfate, Magnesium Oxide And Anhydrous Citric Acid Active Ingredients?

    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/16.1g - 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/16.1g - 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/16.1g

    Which are Sodium Picosulfate, Magnesium Oxide And Anhydrous Citric Acid UNII Codes?

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

    Which are Sodium Picosulfate, Magnesium Oxide And Anhydrous Citric Acid Inactive Ingredients 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 Sodium Picosulfate, Magnesium Oxide And Anhydrous Citric Acid?

    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: 1305808 - sodium picosulfate 10 MG / magnesium oxide 3.5 GM / citric acid 12 GM Powder for Oral Solution
    • RxCUI: 1305808 - citric acid 12000 MG / magnesium oxide 3500 MG / picosulfate sodium 10 MG Powder for Oral Solution
    • RxCUI: 1305808 - citric acid 12 GM / magnesium oxide 3.5 GM / picosulfate sodium 10 MG Powder for Oral Solution

    Which are the Pharmacologic Classes for Sodium Picosulfate, Magnesium Oxide And Anhydrous Citric Acid?

    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.

    * Please review the disclaimer below.

    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.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".