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NDC 68788-9516-01 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 Preferred 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: 68788-9516-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Nystatin Topical

Product Information

NDC	68788-9516
Product ID	68788-9516_7813aab9-5a26-49a9-bcc5-5bce3c4e83de
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
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	Preferred Pharmaceuticals, Inc.
Pharmaceutical Class	Polyene Antifungal [EPC], Polyenes [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA062472
Listing Certified Through	2023-12-31

Package

Package Images

NDC 68788-9516-01 (68788951601)

Pricing Information	N/A
NDC Package Code	68788-9516-1
Billing NDC	68788951601
Package	1 TUBE in 1 CARTON (68788-9516-1) / 15 g in 1 TUBE
Marketing Start Date	2014-02-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d00a5f80-aa50-4b0b-82d2-63ba33a56b2f Details

SPL UNCLASSIFIED SECTION

For Dermatologic Use Only

Not For Ophthalmic Use

Rx Only

DESCRIPTION

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

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

CONTRAINDICATIONS

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

15 g tube (NDC 68788-9516-1)

30 g tube (NDC 68788-9516-3)

STORAGE

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

Manufactured By Perrigo

Bronx, NY 10457

Distributed By

Perrigo®

Allegan, MI 49010 • www.perrigo.com

Rev 08-15

: 2K800 RC JX1

Relabeled By: Preferred Pharmaceuticals Inc.

Principal Display Panel

Rx Only

Nystatin Ointment USP

(100,000 USP Nystatin Units)

NET WT 15g or 30g

INGREDIENTS AND APPEARANCE

NYSTATIN

nystatin ointment

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:68788-9516(NDC:45802-048)
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68788-9516-1	1 in 1 CARTON	02/10/2014
1		15 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:68788-9516-3	1 in 1 CARTON	02/10/2014
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	ANDA062472	02/10/2014

Labeler - Preferred Pharmaceuticals, Inc. (791119022)

Registrant - Preferred Pharmaceuticals, Inc. (791119022)

Name	Address	ID/FEI	Business Operations
Establishment
Preferred Pharmaceuticals, Inc.		791119022	RELABEL(68788-9516)

Revised: 9/2022

Document Id: 7813aab9-5a26-49a9-bcc5-5bce3c4e83de

Set id: d00a5f80-aa50-4b0b-82d2-63ba33a56b2f

Version: 8

Effective Time: 20220915