NDC 0904-7276 Nystatin

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

Product Information

NDC Product Code:
0904-7276
Proprietary Name:
Nystatin
Non-Proprietary Name: [1]
Nystatin
Substance Name: [2]
Nystatin
NDC Directory Status:
Human Prescription 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]
    Major Pharmaceuticals
    Labeler Code:
    0904
    FDA Application Number: [6]
    ANDA203621
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    07-17-2020
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    YELLOW (C48330 - LIGHT-CREAMY)
    Flavor(s):
    CHERRY (C73375 - WITH PEPPERMINT)

    Product Packages

    NDC Code 0904-7276-70

    Package Description: 10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7276-41)

    NDC Code 0904-7276-92

    Package Description: 5 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7276-41)

    Product Details

    What is NDC 0904-7276?

    The NDC code 0904-7276 is assigned by the FDA to the product Nystatin which is a human prescription drug product labeled by Major Pharmaceuticals. The product's dosage form is suspension and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 0904-7276-70 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 ml in 1 cup, unit-dose (0904-7276-41), 0904-7276-92 5 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 ml in 1 cup, unit-dose (0904-7276-41). 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 Nystatin?

    Nystatin is used to treat fungal skin infections. Nystatin is an antifungal that works by stopping the growth of fungus.

    What are Nystatin 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.
    • NYSTATIN 100000 [USP'U]/mL - Macrolide antifungal antibiotic complex produced by Streptomyces noursei, S. aureus, and other Streptomyces species. The biologically active components of the complex are nystatin A1, A2, and A3.

    Which are Nystatin UNII Codes?

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

    Which are Nystatin 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:

    Which are the Pharmacologic Classes for Nystatin?

    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.

    Patient Education

    Nystatin


    Nystatin is used to treat fungal infections of the inside of the mouth and lining of the stomach and intestines. Nystatin is in a class of antifungal medications called polyenes. It works by stopping the growth of fungi that cause infection.
    [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".