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NDC 00168-0007-15 Nystatin 100000 [USP'U]/g Details

Nystatin 100000 [USP'U]/g

Nystatin is a TOPICAL OINTMENT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.. The primary component is NYSTATIN.

MedlinePlus Drug Summary

Topical nystatin is used to treat fungal infections of the skin. Nystatin is in a class of antifungal medications called polyenes. It works by stopping the growth of fungi that cause infection.

Related Packages: 00168-0007-15
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Nystatin Topical

Product Information

NDC	00168-0007
Product ID	0168-0007_2563e491-2277-4393-8632-8127fb983e1d
Associated GPIs	90150080004215
GCN Sequence Number	007283
GCN Sequence Number Description	nystatin OINT. (G) 100000/G TOPICAL
HIC3	Q5F
HIC3 Description	TOPICAL ANTIFUNGALS
GCN	30150
HICL Sequence Number	004129
HICL Sequence Number Description	NYSTATIN
Brand/Generic	Generic
Proprietary Name	Nystatin
Proprietary Name Suffix	n/a
Non-Proprietary Name	nystatin
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	100000
Active Ingredient Units	[USP'U]/g
Substance Name	NYSTATIN
Labeler Name	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Pharmaceutical Class	Polyene Antifungal [EPC], Polyenes [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA062124
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00168-0007-15 (00168000715)

Pricing Information
NDC Package Code	0168-0007-15
Billing NDC	00168000715
Package	15 g in 1 TUBE (0168-0007-15)
Marketing Start Date	1982-09-23
NDC Exclude Flag	N
Price Per Unit	0.30193
Pricing Unit	GM
Effective Date	2024-02-21
NDC Description	NYSTATIN 100,000 UNIT/GM OINT
Pharmacy Type Indicator	C/I
OTC	N
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 01777cce-37ea-499c-ab13-82041a37ccfc Details

SPL UNCLASSIFIED SECTION

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.