NDC 13668-595 Nystatin

Nystatin

NDC Product Code 13668-595

NDC Product Information

Nystatin with NDC 13668-595 is a a human prescription drug product labeled by Torrent Pharmaceuticals Limited. The generic name of Nystatin is nystatin. The product's dosage form is cream and is administered via topical form.

Labeler Name: Torrent Pharmaceuticals Limited

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Prescription Drug 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.

Nystatin Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • NYSTATIN 100000 U/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • CETEARETH-15 (UNII: 867H4YOZ8Z)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • POLYOXYL 8 STEARATE (UNII: 2P9L47VI5E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SORBITOL (UNII: 506T60A25R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Polyene Antifungal - [EPC] (Established Pharmacologic Class)
  • Polyenes - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Torrent Pharmaceuticals Limited
Labeler Code: 13668
FDA Application Number: ANDA212557 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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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.

Start Marketing Date: 07-24-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Nystatin Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. Structural formula: Molecular formula : C47H75NO17 Molecular weight : 926.09 g/molNystatin cream is for dermatologic use. Nystatin cream, USP for topical use, contains 100,000 USP nystatin units per gram. Inactive ingredients: aluminium hydroxide gel, ceteareth-15, mono- and di- glyceride, polyoxyl 8 stearate, propylene glycol, simethicone emulsion, sorbitol solution, titanium dioxide, white petrolatum, methylparaben and propylparaben.

Clinical Pharmacology

PharmacokineticsNystatin is not absorbed from intact skin or mucous membrane.Microbiology Nystatin is an antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi, including Candida albicans, C. parapsilosis, C. tropicalis, C. guilliermondi, C. pseudotropicalis, C. krusei, Torulopsis glabrata, Tricophyton rubrum, T. mentagrophytes. Nystatin acts by binding to sterols in the cell membrane of susceptible species resulting in a change in membrane permeability and the subsequent leakage of intracellular components. On repeated subculturing with increasing levels of nystatin, Candida albicans does not develop resistance to nystatin. Generally, resistance to nystatin does not develop during therapy. However, other species of Candida (C. tropicalis, C. guilliermondi, C. krusei, and C. stellatoides) become quite resistant on treatment with nystatin and simultaneously become cross resistant to amphotericin as well. This resistance is lost when the antibiotic is removed. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

Indications And Usage

Nystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This cream is not indicated for systemic, oral, intravaginal or ophthalmic use.

Contraindications

Nystatin cream is contraindicated in patients with a history of hypersensitivity to any of their components.

Precautions

General Nystatin cream should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections. If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. It is recommended that KOH smears, cultures, or other diagnostic methods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens.

Information For Patients

Patients using these medications should receive the following information and instructions: 1.      The patient should be instructed to use these medications as directed (including the replacement of missed doses). This medication is not for any disorder other than that for which it is prescribed. 2.      Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt or discontinue therapy until the prescribed course of treatment is completed. 3.      If symptoms of irritation develop, the patient should be advised to notify the physician promptly. Laboratory Tests If there is a lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be repeated.Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. No studies have been performed to determine the mutagenicity of nystatin or its effects on male or female fertility. PregnancyTeratogenic Effects Category C. Animal reproduction studies have not been conducted with any nystatin cream. It also is not known whether this cream can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin cream should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.Nursing Mothers It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman. Pediatric Use Safety and effectiveness have been established in the pediatric population from birth to 16 years. (See DOSAGE AND ADMINISTRATION) Geriatric UseClinical studies with nystatin cream did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Adverse Reactions

The frequency of adverse events reported in patients using nystatin cream is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application. (See PRECAUTIONS: General.)

Dosage And Administration

Adults and Pediatric Patients (Neonates and Older)Apply liberally to affected areas twice daily or as indicated until health is complete.

How Supplied

Nystatin Cream, USP, 100,000 units per gram is a yellow to light green color cream available as follows:NDC 13668-595-01 15 g tubeNDC 13668-595-02 30 g tube

Storage And Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Avoid freezing.Manufactured by:TORRENT PHARMACEUTICALS LTD., Pithampur-454775, INDIA.Manufactured for:TORRENT PHARMA INC., Basking Ridge, NJ 079208069674                                                                                                                  June 2019

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