NDC 72578-088 Nystatin And Triamcinolone Acetonide

Ointment Topical - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
72578-088
Proprietary Name:
Nystatin And Triamcinolone Acetonide
Non-Proprietary Name: [1]
Nystatin And Triamcinolone Acetonide
Substance Name: [2]
Nystatin; Triamcinolone Acetonide
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route(s): [4]
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Labeler Name: [5]
    Viona Pharmaceuticals Inc
    Labeler Code:
    72578
    FDA Application Number: [6]
    ANDA207764
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    06-24-2020
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    YELLOW (C48330 - YELLOW)

    Product Packages

    NDC Code 72578-088-01

    Package Description: 1 TUBE in 1 CARTON / 15 g in 1 TUBE

    Price per Unit: $0.28861 per GM

    NDC Code 72578-088-02

    Package Description: 1 TUBE in 1 CARTON / 60 g in 1 TUBE

    Price per Unit: $0.17029 per GM

    NDC Code 72578-088-04

    Package Description: 1 TUBE in 1 CARTON / 30 g in 1 TUBE

    Price per Unit: $0.32283 per GM

    Product Details

    What is NDC 72578-088?

    The NDC code 72578-088 is assigned by the FDA to the product Nystatin And Triamcinolone Acetonide which is a human prescription drug product labeled by Viona Pharmaceuticals Inc. The product's dosage form is ointment and is administered via topical form. The product is distributed in 3 packages with assigned NDC codes 72578-088-01 1 tube in 1 carton / 15 g in 1 tube, 72578-088-02 1 tube in 1 carton / 60 g in 1 tube, 72578-088-04 1 tube in 1 carton / 30 g in 1 tube. 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 And Triamcinolone Acetonide?

    Nystatin and Triamcinolone Acetonide Ointment are indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.

    What are Nystatin And Triamcinolone Acetonide 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]/g - 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.
    • TRIAMCINOLONE ACETONIDE 1 mg/g - An esterified form of TRIAMCINOLONE. It is an anti-inflammatory glucocorticoid used topically in the treatment of various skin disorders. Intralesional, intramuscular, and intra-articular injections are also administered under certain conditions.

    Which are Nystatin And Triamcinolone Acetonide UNII Codes?

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

    Which are Nystatin And Triamcinolone Acetonide 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 Nystatin And Triamcinolone Acetonide?

    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: 1053697 - nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical Ointment
    • RxCUI: 1053697 - nystatin 100 UNT/MG / triamcinolone acetonide 0.001 MG/MG Topical Ointment
    • RxCUI: 1053697 - nystatin 100,000 UNT/GM / triamcinolone acetonide 0.1 % Topical Ointment

    Which are the Pharmacologic Classes for Nystatin And Triamcinolone Acetonide?

    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 and Triamcinolone


    The combination of nystatin and triamcinolone is used to treat fungal skin infections. It relieves itching, inflammation, and pain. 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".