NDC 51079-306 Polyethylene Glycol (3350)

Powder, For Solution Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
51079-306
Proprietary Name:
Polyethylene Glycol (3350)
Non-Proprietary Name: [1]
Polyethylene Glycol (3350)
Substance Name: [2]
Polyethylene Glycol 3500
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Mylan Institutional Inc.
    Labeler Code:
    51079
    FDA Application Number: [6]
    ANDA078915
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    10-12-2009
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)

    Product Packages

    NDC Code 51079-306-30

    Package Description: 30 POUCH in 1 CARTON / 17 g in 1 POUCH (51079-306-01)

    Price per Unit: $1.13705 per EA

    Product Details

    What is NDC 51079-306?

    The NDC code 51079-306 is assigned by the FDA to the product Polyethylene Glycol (3350) which is a human over the counter drug product labeled by Mylan Institutional Inc.. The product's dosage form is powder, for solution and is administered via oral form. The product is distributed in a single package with assigned NDC code 51079-306-30 30 pouch in 1 carton / 17 g in 1 pouch (51079-306-01). 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 Polyethylene Glycol (3350)?

    •do not take more than directed unless advised by your doctor•adults and children 17 years of age and older:•stir and dissolve the contents of one pouch (17 g) into any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink•use once a day•use no more than 7 days•children 16 years of age or under: ask a doctor

    What are Polyethylene Glycol (3350) 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 Polyethylene Glycol (3350) UNII Codes?

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

    • POLYETHYLENE GLYCOL 3500 (UNII: FVS1AZD90Y)
    • POLYETHYLENE GLYCOL 3500 (UNII: FVS1AZD90Y) (Active Moiety)

    What is the NDC to RxNorm Crosswalk for Polyethylene Glycol (3350)?

    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: 876193 - polyethylene glycol 3350 17 GM Powder for Oral Solution
    • RxCUI: 876193 - polyethylene glycol 3350 17000 MG Powder for Oral Solution

    * Please review the disclaimer below.

    Patient Education

    Polyethylene Glycol 3350


    Polyethylene glycol 3350 is used to treat occasional constipation. Polyethylene glycol 3350 is in a class of medications called osmotic laxatives. It works by causing water to be retained with the stool. This increases the number of bowel movements and softens the stool so it is easier to pass.
    [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".