NDC 28595-240 Augmentin

Amoxicillin And Clavulanate Potassium For Suspension Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
28595-240
Proprietary Name:
Augmentin
Non-Proprietary Name: [1]
Amoxicillin And Clavulanate Potassium
Substance Name: [2]
Amoxicillin; Clavulanate Potassium
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
For Suspension - A product, usually a solid, intended for suspension prior to administration.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Allegis Pharmaceuticals, Llc
    Labeler Code:
    28595
    FDA Application Number: [6]
    NDA050575
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    02-23-2023
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Flavor(s):
    BANANA (C73364)

    Product Packages

    NDC Code 28595-240-35

    Package Description: 100 mL in 1 BOTTLE

    NDC Code 28595-240-36

    Package Description: 150 mL in 1 BOTTLE

    Product Details

    What is NDC 28595-240?

    The NDC code 28595-240 is assigned by the FDA to the product Augmentin which is a human prescription drug product labeled by Allegis Pharmaceuticals, Llc. The generic name of Augmentin is amoxicillin and clavulanate potassium. The product's dosage form is for suspension and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 28595-240-35 100 ml in 1 bottle , 28595-240-36 150 ml 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 Augmentin?

    Amoxicillin/clavulanic acid is a combination penicillin-type antibiotic used to treat a wide variety of bacterial infections. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

    What are Augmentin 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.
    • AMOXICILLIN 125 mg/5mL - A broad-spectrum semisynthetic antibiotic similar to AMPICILLIN except that its resistance to gastric acid permits higher serum levels with oral administration.
    • CLAVULANATE POTASSIUM 31.25 mg/5mL - A beta-lactam antibiotic produced by the actinobacterium Streptomyces clavuligerus. It is a suicide inhibitor of bacterial beta-lactamase enzymes. Administered alone, it has only weak antibacterial activity against most organisms, but given in combination with other beta-lactam antibiotics it prevents antibiotic inactivation by microbial lactamase.

    Which are Augmentin UNII Codes?

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

    Which are Augmentin 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 Augmentin?

    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: 617302 - amoxicillin 125 MG / clavulanic acid 31.25 MG in 5 mL Oral Suspension
    • RxCUI: 617302 - amoxicillin 25 MG/ML / clavulanate 6.25 MG/ML Oral Suspension
    • RxCUI: 617302 - amoxicillin (as amoxicillin trihydrate) 25 MG/ML / clavulanate (as clavulanate potassium) 6.25 MG/ML Oral Suspension
    • RxCUI: 617302 - amoxicillin 125 MG / clavulanic acid 31.25 MG per 5 ML Oral Suspension
    • RxCUI: 617333 - AUGMENTIN 125 MG / 31.25 MG in 5 mL Oral Suspension

    Which are the Pharmacologic Classes for Augmentin?

    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.

    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".