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  4. NDC Product Code: 62135-496 Griseofulvin Microsize

NDC 62135-496 Griseofulvin Microsize

Griseofulvin Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 62135-496?
  5. Griseofulvin Microsize Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

NDC Product Code:
62135-496
Proprietary Name:
Griseofulvin Microsize
Non-Proprietary Name: [1]
Griseofulvin
Substance Name: [2]
Griseofulvin
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Chartwell Rx, Llc.
    Labeler Code:
    62135
    Product Label ID:
    6902a976-b0c5-48a4-8d50-984002be6c3a
    FDA Application Number: [6]
    ANDA060569
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    09-09-1971
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)
    Shape:
    ROUND (C48348)
    Size(s):
    12 MM
    Imprint(s):
    CE;5
    Score:
    2

    Product Packages

    NDC Code 62135-496-01

    Package Description: 100 TABLET in 1 BOTTLE

    Price per Unit: $7.74447 per EA

    NDC Code 62135-496-30

    Package Description: 30 TABLET in 1 BOTTLE

    Price per Unit: $7.74447 per EA

    Product Details

    What is NDC 62135-496?

    The NDC code 62135-496 is assigned by the FDA to the product Griseofulvin Microsize which is a human prescription drug product labeled by Chartwell Rx, Llc.. The generic name of Griseofulvin Microsize is griseofulvin. The product's dosage form is tablet and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 62135-496-01 100 tablet in 1 bottle , 62135-496-30 30 tablet 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 Griseofulvin Microsize?

    Griseofulvin tablets, USP are indicated for the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair and nails, namely:Tinea corporisTinea pedisTinea crurisTinea barbaeTinea capitisTinea unguium when caused by one or more of the following species of fungi:Epidermophyton floccosumMicrosporum audouiniiMicrosporum canisMicrosporum gypseumTrichophyton crateriformTrichophyton gallinaeTrichophyton interdigitalisTrichophyton megniniTrichophyton mentagrophytesTrichophyton rubrumTrichophyton schoenleiniTrichophyton sulphureumTrichophyton tonsuransTrichophyton verrucosumNote: Prior to therapy, a dermatophyte should be identified as responsible for the infection.Prior to initiating treatment, appropriate specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis.Griseofulvin tablets, USP are not effective in the following:Bacterial infectionsCandidiasis (Moniliasis)HistoplasmosisActinomycosisSporotrichosisChromoblastomycosisCoccidioidomycosisNorth American BlastomycosisCryptococcosis (Torulosis)Tinea versicolorNocardiosisThe use of this drug is not justified in minor or trivial dermatophyte infections which will respond to topical agents alone.

    What are Griseofulvin Microsize 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 Griseofulvin Microsize UNII Codes?

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

    Which are Griseofulvin Microsize 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 Griseofulvin Microsize?

    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 code indicates a single concept unique identifier (RXCUI) is associated with this product:

    Which are the Pharmacologic Classes for Griseofulvin Microsize?

    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

    Griseofulvin


    Griseofulvin is used to treat skin infections such as jock itch, athlete's foot, and ringworm; and fungal infections of the scalp, fingernails, and toenails. 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".