Search by Drug Name or NDC

NDC 72578-0089-01 Nystatin 100000 U/g Details

Nystatin 100000 U/g

Nystatin is a TOPICAL OINTMENT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Viona 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: 72578-0089-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Nystatin Topical

Product Information

NDC	72578-0089
Product ID	72578-089_3d917a6c-4e9a-4c45-9e79-caf91f8b11b0
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	U/g
Substance Name	NYSTATIN
Labeler Name	Viona Pharmaceuticals Inc
Pharmaceutical Class	Polyene Antifungal [EPC], Polyenes [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA207767
Listing Certified Through	2024-12-31

Package

Package Images

NDC 72578-0089-01 (72578008901)

Pricing Information
NDC Package Code	72578-089-01
Billing NDC	72578008901
Package	15 g in 1 TUBE (72578-089-01)
Marketing Start Date	2020-06-24
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 e135a7d2-adba-48a2-b3e1-07b778cce9b0 Details

DESCRIPTION

Nystatin is a polyene antifungal antibiotic drug obtained from Streptomyces nursei.

Structural formula:

Nystatin Ointment is for dermatologic use. Nystatin Ointment USP, for topical use only, contains 100,000 USP Nystatin Units per gram, in a white petrolatum and light mineral oil base.

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 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 PATIENTS

Patients using these medications should receive the following information and instructions:

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.
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.
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.

Pregnancy: Teratogenic Effects

Category C.

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.

See DOSAGE 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.

(See PRECAUTIONS: General.)

DOSAGE AND 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 yellow colored ointment is supplied in 15g and 30g tubes.

NDC 72578-089-01 in tube of 15 gm

NDC 72578-089-04 in tube of 30 gm

STORAGE

NYSTATIN Ointment: Store at room temperature.

Call your doctor for medical advice about side effects. You may report side effects to Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088.

SPL UNCLASSIFIED SECTION

Manufactured by:

Zydus Lifesciences Ltd.

Changodar, Ahmedabad, India.

Distributed by:

Viona Pharmaceuticals Inc.

Cranford, NJ 07016

Rev.: 06/22

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

72578-089-01

Nystatin Ointment USP, 15 g

Rx only

INGREDIENTS AND APPEARANCE

NYSTATIN

nystatin ointment

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:72578-089
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	YELLOW (YELLOW)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72578-089-01	15 g in 1 TUBE; Type 0: Not a Combination Product	06/24/2020
2	NDC:72578-089-04	30 g in 1 TUBE; Type 0: Not a Combination Product	06/24/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA207767	06/24/2020

Labeler - Viona Pharmaceuticals Inc (081468959)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		650650802	ANALYSIS(72578-089) , MANUFACTURE(72578-089)

Revised: 10/2022

Document Id: 3d917a6c-4e9a-4c45-9e79-caf91f8b11b0

Set id: e135a7d2-adba-48a2-b3e1-07b778cce9b0

Version: 4

Effective Time: 20221008