NDC 54257-479 Fiber Laxative

Calcium Polycarbophil Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
54257-479
Proprietary Name:
Fiber Laxative
Non-Proprietary Name: [1]
Calcium Polycarbophil
Substance Name: [2]
Calcium Polycarbophil
NDC Directory Status:
Human Otc 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]
    Magno-humphries, Inc.
    Labeler Code:
    54257
    FDA Application Number: [6]
    M007
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    07-25-2022
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325 - OFF-WHITE)
    Shape:
    OVAL (C48345)
    Size(s):
    18 MM
    Imprint(s):
    RP120
    Score:
    1

    Product Packages

    NDC Code 54257-479-07

    Package Description: 90 TABLET in 1 BOTTLE

    Product Details

    What is NDC 54257-479?

    The NDC code 54257-479 is assigned by the FDA to the product Fiber Laxative which is a human over the counter drug product labeled by Magno-humphries, Inc.. The generic name of Fiber Laxative is calcium polycarbophil. 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 54257-479-07 90 tablet in 1 bottle . 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 Fiber Laxative?

    This medication is used to treat constipation. It increases the bulk in your stool, an effect that helps to cause movement of the intestines. It also works by increasing the amount of water in the stool, making the stool softer and easier to pass. Psyllium, one type of bulk-forming laxative, has also been used along with a proper diet to treat high cholesterol.

    What are Fiber Laxative 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 Fiber Laxative UNII Codes?

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

    Which are Fiber Laxative 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 Fiber Laxative?

    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: 308934 - calcium polycarbophil 625 MG Oral Tablet
    • RxCUI: 308934 - calcium polycarbophil 625 MG (as polycarbophil 500 MG) Oral Tablet

    * 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".