NDC 0168-0007 Nystatin
Ointment Topical

Product Information

Nystatin is a human prescription drug product labeled by E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.. The product's dosage form is ointment and is administered via topical form.

Product Code0168-0007
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Nystatin
Non-Proprietary Name 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.
Nystatin
Product Type 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.
Human Prescription Drug
Dosage FormOintment - 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) 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.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.
Labeler Code0168
FDA Application Number 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.
ANDA062124
Marketing Category 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.
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
09-23-1982
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Nystatin?


Product Packages

NDC 0168-0007-15

Package Description: 15 g in 1 TUBE

Price per Unit: $0.27739 per GM

NDC 0168-0007-30

Package Description: 30 g in 1 TUBE

Price per Unit: $0.26794 per GM

Product Details

What are Nystatin 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.

Nystatin Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? 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:

Nystatin 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.

Pharmacologic Class(es)

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.

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Patient Education

Nystatin

Nystatin is pronounced as (nye stat' in)

Why is nystatin medication prescribed?
Nystatin is used to treat fungal infections of the skin, mouth, vagina, and intestinal tract. Fungal medicines will not work for colds, flu, or other viral infections.Thi...
[Read More]

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Nystatin Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Rx only


Description



Nystatin Ointment USP, for topical use only, contains 100,000 USP Nystatin Units per gram, in a polyethylene and mineral oil base. The structural formula is as follows:


Clinical Pharmacology



Nystatin is an antifungal antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. It probably acts by binding to sterols in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin is a polyene antibiotic that is obtained from Streptomyces noursei, and is the first well tolerated antifungal antibiotic of dependable efficacy for the treatment of cutaneous, oral and intestinal infections caused by Candida [Monilia]albicans and other Candida species. It exhibits no appreciable activity against bacteria.

Nystatin provides specific therapy for all localized forms of candidiasis. Symptomatic relief is rapid, often occurring within 24 to 72 hours after the initiation of treatment. Cure is effected both clinically and mycologically in most cases of localized candidiasis.


Indications And Usage



Nystatin Ointment is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida [Monilia]albicans and other Candida species.


Contraindications



Nystatin Ointment is contraindicated in patients with a history of hypersensitivity to any of its components.


Precautions



Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.

This preparation is not for ophthalmic use.


Adverse Reactions



Nystatin is virtually non-toxic and nonsensitizing and is well tolerated by all age groups including debilitated infants, even on prolonged administration. If irritation on topical application should occur, discontinue medication.


Dosage And Administration



Nystatin Ointment should be applied liberally to affected areas twice a day or as indicated until healing is complete. Nystatin cream is usually preferred to nystatin ointment in candidiasis involving intertriginous areas; very moist lesions, however, are best treated with nystatin topical powder.

This preparation does not stain skin or mucous membranes and provides a simple, convenient means of treatment.


How Supplied



Nystatin Ointment (100,000 USP Nystatin Units per gram) is a yellow ointment available as follows:

NDC 0168-0007-15 15 gram tube
NDC 0168-0007-30 30 gram tube

Store at controlled room temperature 15°- 30°C (59°-86°F).

E. FOUGERA & CO.
A division of Fougera Pharmaceuticals Inc.
Melville, New York 11747
I20715H
R08/11
#21


Package Label – Principal Display Panel – 15 G Container



NDC 0168-0007-15

FOUGERA®

NYSTATIN OINTMENT USP

100,000 USP Nystatin Units Per Gram

For Topical Use Only.

Not for Ophthalmic Use.

Rx only

CONTAINS: 100,000 USP

Nystatin Units per gram,

in a polyethylene and

mineral oil base.

NET WT 15 grams


Package Label – Principal Display Panel – 15 G Carton



NDC 0168-0007-15

FOUGERA®    Rx only

NYSTATIN OINTMENT USP

100,000 USP Nystatin Units Per Gram

WARNING: Keep this and all

drugs out of reach of children.

For Topical Use Only.

Not for Ophthalmic Use.

NET WT 15 grams


* Please review the disclaimer below.