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  4. NDC Product Code: 55758-383 Mebendamax Pinworm

NDC 55758-383 Mebendamax Pinworm

Pyrantel Pamoate Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 55758-383?
  5. Mebendamax Pinworm Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes

Product Information

NDC Product Code:
55758-383
Proprietary Name:
Mebendamax Pinworm
Non-Proprietary Name: [1]
Pyrantel Pamoate
Substance Name: [2]
Pyrantel Pamoate
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]
    Pharmadel Llc
    Labeler Code:
    55758
    Product Label ID:
    12f56a34-15ba-949f-e063-6394a90a22d3
    FDA Application Number: [6]
    M024
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    04-01-2024
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)
    Shape:
    ROUND (C48348)
    Size(s):
    13 MM
    Imprint(s):
    G

    Code Structure Chart

    Product Details

    What is NDC 55758-383?

    The NDC code 55758-383 is assigned by the FDA to the product Mebendamax Pinworm which is a human over the counter drug product labeled by Pharmadel Llc. The generic name of Mebendamax Pinworm is pyrantel pamoate. 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 55758-383-10 10 blister pack in 1 carton / 1 tablet in 1 blister pack. 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 Mebendamax Pinworm?

    READ THE PACKAGE CAREFULLY BEFORE TAKING THIS MEDICATION.take only according to directionsdo not exceed the recommended dosage, unless directed by a doctormedication should only be taken one time as a single dose; do not repeat treatmentwhen one individual in a household has pinworms, the entire household should be treated unless otherwise advisedadults, children 12 years of age and over, and children 2 years to under 12 years of age:this product can be taken any time of day, with or without meals. It may be taken alone or with milk or fruit juice.use of a laxative is not necessary before, during, or after medicationoral dosage is a single dose of 5 mg of pyrantel base per pound or 11 mg of pyrantel base per kilogram of body weight not to exceed 1 gram (1000mg)children under 25 lbs. or 2yrs old: do not use unless directed by a doctor WeightDosage (taken as a single dose) Less than 25 lb. or under 2 yrs. olddo not use unless directed by a doctor25-37 lbs.2 tablets38-62 lbs.4 tablets63-87 lbs.6 tablets88-112 lbs.8 tablets113-137 lbs.10 tablets138-162 lbs.12 tablets163-187 lbs.14 tablets188 lbs. and over16 tablets

    What are Mebendamax Pinworm 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 Mebendamax Pinworm UNII Codes?

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

    Which are Mebendamax Pinworm 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:

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    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".