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  4. NDC Product Code: 52268-201 Sutab

NDC 52268-201 Sutab

Sodium Sulfate,Magnesium Sulfate,And Potassium Chloride Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 52268-201?
  5. Sutab Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. Pharmacologic Classes
  10. Patient Education

Product Information

NDC Product Code:
52268-201
Proprietary Name:
Sutab
Non-Proprietary Name: [1]
Sodium Sulfate, Magnesium Sulfate, And Potassium Chloride
Substance Name: [2]
Magnesium Sulfate Anhydrous; Potassium Chloride; Sodium Sulfate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Braintree Laboratories, Inc.
    Labeler Code:
    52268
    Product Label ID:
    dddd2701-4d46-44de-a9f8-303d4dcceef7
    FDA Application Number: [6]
    NDA213135
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    11-10-2020
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325 - WHITE TO OFF-WHITE)
    Shape:
    OVAL (C48345)
    Size(s):
    19 MM
    Imprint(s):
    S24
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 52268-201?

    The NDC code 52268-201 is assigned by the FDA to the product Sutab which is a human prescription drug product labeled by Braintree Laboratories, Inc.. The generic name of Sutab is sodium sulfate, magnesium sulfate, and potassium chloride. The product's dosage form is tablet and is administered via oral form. The product is distributed in a single package with assigned NDC code 52268-201-01 2 bottle, plastic in 1 kit / 12 tablet in 1 bottle, plastic. 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 Sutab?

    SUTAB is indicated for the cleansing of the colon as a preparation for colonoscopy in adults.

    What are Sutab 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.

    Which are Sutab UNII Codes?

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

    Which are Sutab 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:

    • POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
    • SODIUM CAPRYLATE (UNII: 9XTM81VK2B)
    • ETHYLENE GLYCOL (UNII: FC72KVT52F)
    • POLYVINYL ALCOHOL GRAFT POLYETHYLENE GLYCOL COPOLYMER (3:1; 45000 MW) (UNII: 23ZQ42JZZH)

    Which are the Pharmacologic Classes for Sutab?

    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

    Magnesium Sulfate, Potassium Sulfate, and Sodium Sulfate


    Magnesium sulfate, potassium sulfate, and sodium sulfate is used 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) in adults and children 12 years of age and older so that the doctor will have a clear view of the walls of the colon. Magnesium sulfate, potassium sulfate, and sodium sulfate is in a class of medications called osmotic laxatives. It works 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".