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NDC 33342-0481-30 Nystatin 100000 1/g Details

Nystatin 100000 1/g

Nystatin is a TOPICAL OINTMENT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Macleods Pharmaceuticals Limited. 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: 33342-0481-30
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Nystatin Topical

Product Information

NDC	33342-0481
Product ID	33342-481_fe3db8b2-9de4-4f9e-b763-8536a1e4cea8
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	1/g
Substance Name	NYSTATIN
Labeler Name	Macleods Pharmaceuticals Limited
Pharmaceutical Class	Polyene Antifungal [EPC], Polyenes [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA213826
Listing Certified Through	2024-12-31

Package

Package Images

NDC 33342-0481-30 (33342048130)

Pricing Information
NDC Package Code	33342-481-30
Billing NDC	33342048130
Package	1 TUBE in 1 CARTON (33342-481-30) / 30 g in 1 TUBE
Marketing Start Date	2021-01-29
NDC Exclude Flag	N
Price Per Unit	0.25853
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 fe3db8b2-9de4-4f9e-b763-8536a1e4cea8 Details

DESCRIPTION

Nystatin is a polyene antifungal antibiotic drug obtained from Streptomyces nursei

Nystatin Ointment USP, for topical use only, contains 100,000 USP Nystatin Units per gram, in an ointment base of light mineral oil and white petrolatum. The structural formula is as follows:

Molecular Weight 926.13

Molecular Formula C47H75NO17

CLINICAL PHARMACOLOGY

Pharmacokinetics

Nystatin 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 concentrations of nystatin, Candida albicans does not develop resistance to nystatin.Generally, resistance to nystatin does not develop during therapy. However, other species of 47 75 17 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 Ointment, is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.

Nystatin Ointment is not indicated for systemic, oral, intravaginal or ophthalmic use.

CONTRAINDICATIONS

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

PRECAUTIONS

General

Nystatin Ointment 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 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). These medications are not for any disorder other than that for which they are 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.

Carcinogenisis, Mutagenisis, 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.

Pregnancy: Teratogenic Effects

Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether these preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin topical preparations 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.

SeeDOSAGE AND ADMINISTRATION

ADVERSE REACTIONS

The frequency of adverse events reported in patients using Nystatin Ointment preparations is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application.

(SeePRECAUTIONS: General.)

To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc., at 1-888-943-3210 or 1-855-926-338 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).

DOSAGE & ADMINISTRATION

Nystatin Ointment

Adults and Pediatric Patients (Neonates and Older):

Apply liberally to affected areas twice daily or as indicated until healing is complete.

HOW SUPPLIED

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

NDC 33342-481-15 15 gram tube

NDC 33342-481-30 30 gram tube

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Manufactured for:

Macleods Pharma USA, Inc.

Princeton, NJ 08540

Manufacturer:

Macleods Pharmaceuticals Limited

At Oxalis Labs

Baddi, Himachal Pradesh, INDIA

Rev. 01/2021

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nystatin Ointment (100,000 USP Nystatin Units per gram)

Pack Count: 15 g Tube

NDC 33342-481-15

Nystatin Ointment (100,000 USP Nystatin Units per gram)

Pack Count: 15 g Carton

NDC 33342-481-15

Nystatin Ointment (100,000 USP Nystatin Units per gram)

Pack Count: 30 g Tube

NDC 33342-481-30

Nystatin Ointment (100,000 USP Nystatin Units per gram)

Pack Count: 30 g Carton

NDC 33342-481-30

INGREDIENTS AND APPEARANCE

NYSTATIN

nystatin ointment

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:33342-481
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E)	NYSTATIN	100000 in 1 g

Ingredient Name	Strength
Inactive Ingredients
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	YELLOW	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:33342-481-15	1 in 1 CARTON	01/29/2021
1		15 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:33342-481-30	1 in 1 CARTON	01/29/2021
2		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA213826	01/29/2021

Labeler - Macleods Pharmaceuticals Limited (862128535)

Name	Address	ID/FEI	Business Operations
Establishment
OXALIS LABS		860120472	ANALYSIS(33342-481) , LABEL(33342-481) , MANUFACTURE(33342-481) , PACK(33342-481)

Revised: 1/2021

Document Id: fe3db8b2-9de4-4f9e-b763-8536a1e4cea8

Set id: fe3db8b2-9de4-4f9e-b763-8536a1e4cea8

Version: 1

Effective Time: 20210129