NDC 41520-426 Careone Tioconazole 1

Tioconazole Ointment Vaginal - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
41520-426
Proprietary Name:
Careone Tioconazole 1
Non-Proprietary Name: [1]
Tioconazole
Substance Name: [2]
Tioconazole
NDC Directory Status:
Human Otc 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]
  • Vaginal - Administration into the vagina.
  • Labeler Name: [5]
    American Sales Company
    Labeler Code:
    41520
    FDA Application Number: [6]
    ANDA075915
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    01-07-2008
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    BROWN (C48332 - LIGHT TO DARK TAN)

    Product Packages

    NDC Code 41520-426-54

    Package Description: 1 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR

    Product Details

    What is NDC 41520-426?

    The NDC code 41520-426 is assigned by the FDA to the product Careone Tioconazole 1 which is a human over the counter drug product labeled by American Sales Company. The generic name of Careone Tioconazole 1 is tioconazole. The product's dosage form is ointment and is administered via vaginal form. The product is distributed in a single package with assigned NDC code 41520-426-54 1 pouch in 1 carton / 1 applicator in 1 pouch / 4.6 g in 1 applicator. 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 Careone Tioconazole 1?

    •before using this product, read the enclosed brochure and instructions on printed packet for complete directions and information•adults and children 12 years of age and over:•open the printed packet just before use and remove purple cap•insert entire contents of applicator into the vagina at bedtime. Throw applicator away after use.•children under 12 years of age: ask a doctor

    What are Careone Tioconazole 1 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 Careone Tioconazole 1 UNII Codes?

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

    Which are Careone Tioconazole 1 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 Careone Tioconazole 1?

    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:

    Which are the Pharmacologic Classes for Careone Tioconazole 1?

    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".