NDC 13985-918 Pyrantel Pamoate

Pinwormtreatment Suspension Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
13985-918
Proprietary Name:
Pyrantel Pamoate
Non-Proprietary Name: [1]
Pinwormtreatment
Substance Name: [2]
Pyrantel Pamoate
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Mwi Veterinary Supply, Inc.
    Labeler Code:
    13985
    FDA Application Number: [6]
    part357B
    Marketing Category: [8]
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date: [9]
    04-19-2017
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 13985-918-16

    Package Description: 473.2 mL in 1 BOTTLE, PLASTIC

    NDC Code 13985-918-32

    Package Description: 946.4 mL in 1 BOTTLE, PLASTIC

    Product Details

    What is NDC 13985-918?

    The NDC code 13985-918 is assigned by the FDA to the product Pyrantel Pamoate which is a human over the counter drug product labeled by Mwi Veterinary Supply, Inc.. The generic name of Pyrantel Pamoate is pinwormtreatment. The product's dosage form is suspension and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 13985-918-16 473.2 ml in 1 bottle, plastic , 13985-918-32 946.4 ml 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 Pyrantel Pamoate?

    Shake well before use.Take only according to directions and do not exceed the recommended dosage unless directed by a physician.Medication should only be taken one time as a single dose, do not repeat treatment - unless directed by a physician.When one individual in a household has pinworms, the entire household should be treated unless otherwise advised.This product can be taken any time of day, with or without meals. It may be taken alone or with milk or juice.Use of a laxative is not necessary prior to, during, or after medication.Adults, children 12 years of age and over, and children 2 years to under 12 years of age - oral dosage is a single dose of 5 milligrams of Pyrantel Base per pound (or 11 milligrams per kilogram) of body weight, not to exceed 1 gram (4 teaspoonfuls).Dosage information: Each 5 mL (1 teaspoonful) of Pyrantel Pamoate Suspension contains the equivalent of 250 mg of Pyrantel Base.Read package insert carefully before taking this medication.If any worms other than pinworms are present before or after treatment, consult a physician.If any symptoms or pinworms are still present after treatment, consult a physician.Less than 25 Pounds or under 2 years old................Do not us unless directed by a physician.25 to 37 Pounds....................................................½ teaspoonful (125 mg)38 to 62 Pounds....................................................1 teaspoonful (250 mg)63 to 87 Pounds....................................................1½ teaspoonfuls (375 mg)88 to 112 Pounds..................................................2 teaspoonfuls (500 mg)113 to 137 Pounds................................................2½ teaspoonfuls (625 mg)138 to 162 Pounds................................................3 teaspoonfuls (750 mg)163 to 187 Pounds................................................3½ teaspoonfuls (875 mg)188 Pounds and over.............................................4 teaspoonfuls (1000 mg)

    What are Pyrantel Pamoate 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 Pyrantel Pamoate UNII Codes?

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

    Which are Pyrantel Pamoate 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 Pyrantel Pamoate?

    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:

    * Please review the disclaimer below.

    Patient Education

    Pyrantel


    Pyrantel, an antiworm medication, is used to treat roundworm, hookworm, pinworm, and other worm infections. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
    [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".