Nystatin

E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.
Human Prescription Drug
NDC 0168-0054

Nystatin is a human prescription drug labeled by 'E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.'. National Drug Code (NDC) number for Nystatin is 0168-0054. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Nystatin drug includes Nystatin - 100000 [USP'U]/g . The currest status of Nystatin drug is Active.

Drug Information:

Drug NDC:	0168-0054
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Nystatin
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Nystatin
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Cream
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	NYSTATIN - 100000 [USP'U]/g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	01 Feb, 1979
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	12 Jan, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	ANDA062129
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.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	543546
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0301680054155
UPC stands for Universal Product Code.
NUI:	N0000175498 M0017172
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	BDF1O1C72E
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:	Polyene Antifungal [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class CS:	Polyenes [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Polyene Antifungal [EPC] Polyenes [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
0168-0054-15	1 TUBE in 1 CARTON (0168-0054-15) / 15 g in 1 TUBE	01 Feb, 1979	N/A	No
0168-0054-30	1 TUBE in 1 CARTON (0168-0054-30) / 30 g in 1 TUBE	01 Feb, 1979	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

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Product Elements:

Nystatin nystatin nystatin nystatin polysorbate 60 algeldrate titanium dioxide glyceryl monostearate peg-8 stearate silicon dioxide sorbic acid propylene glycol ethylenediamine sorbitol methylparaben propylparaben hydrochloric acid petrolatum water

Indications and Usage:

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.

General 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 the patient: patients using this medication should receive the following information and instructions: 1. the patient should be instructed to use this medication 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, th Read more...

e patient should be advised to notify the physician promptly.

Dosage and Administration:

Dosage and administration: adults and pediatric patients (neonates and older) : apply liberally to affected area twice daily or as indicated until healing is complete.

Contraindications:

Contraindications: nystatin cream is contraindicated in patients with a history of hypersensitivity to any of their components.

Adverse Reactions:

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. )

Use in Pregnancy:

Pregnancy: teratogenic 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.

Pediatric Use:

Pediatric use : safety and effectiveness have been established in the pediatric population from birth to 16 years. (see dosage and administration .)

Geriatric Use:

Geriatric use : clinical 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.]

Description:

Description: nystatin is a polyene antifungal antibiotic obtained from streptomyces nursei . structural formula: molecular weight 926.13 molecular formula c 47 h 75 no 17 nystatin cream is for dermatologic use. nystatin cream for topical use, contains 100,000 usp nystatin units per gram in an aqueous, vanishing cream base containing polysorbate 60, aluminum hydroxide compressed gel, titanium dioxide, glyceryl monostearate, polyethylene glycol 400 monostearate, simethicone emulsion, sorbic acid, propylene glycol, ethylenediamine, polyoxyethylene fatty alcohol ether, sorbitol solution, methylparaben, propylparaben, hydrochloric acid, white petrolatum, and purified water. structure

Clinical Pharmacology:

Clinical pharmacology: pharmacokinetics: nystatin is not absorbed from intact skin or mucous membrane. microbiology: nystatin is an antifungal 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 amphote Read more...

ricin as well. this resistance is lost when the antibiotic is removed. nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

Pharmacokinetics:

Pharmacokinetics: nystatin is not absorbed from intact skin or mucous membrane. microbiology: nystatin is an antifungal 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 res Read more...

istance is lost when the antibiotic is removed. nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

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 the effects on male or female fertility.

How Supplied:

How supplied: nystatin cream usp is available as follows: ndc 0168-0054-15 15 gram tube ndc 0168-0054-30 30 gram tube each tube provides 100,000 usp nystatin units per gram. store at 20Â°-25Â°c (68Â°-77Â°f) [see usp controlled room temperature]. avoid freezing. e. fougera & co. a division of fougera pharmaceuticals inc. melville, new york 11747 i25415g r07/13 #61

Package Label Principal Display Panel:

Package label â principal display panel â 15g container ndc 0168-0054-15 fougera Â® nystatin cream usp 100,000 usp nystatin units per gram for external use only. not for ophthalmic use. rx only net wt 15 grams 15gtubelabel

Package label â principal display panel â 15 g carton ndc 0168-0054-15 rx only fougera Â® nystatin cream usp 100,000 usp nystatin units per gram warning: keep this and all drugs out of reach of children. for external use only. not for ophthalmic use. net wt 15 grams 15gramcarton

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.