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NDC 63187-0464-15 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 Proficient Rx LP. 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: 63187-0464-15
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Nystatin Topical

Product Information

NDC	63187-0464
Product ID	63187-464_2aeb648a-b45f-4dd7-93f0-610d7490b464
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	Proficient Rx LP
Pharmaceutical Class	Polyene Antifungal [EPC], Polyenes [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA062840
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63187-0464-15 (63187046415)

Pricing Information	N/A
NDC Package Code	63187-464-15
Billing NDC	63187046415
Package	1 TUBE in 1 CARTON (63187-464-15) / 15 g in 1 TUBE
Marketing Start Date	2019-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d7d04c02-d07d-4382-8f93-5c0c3e68790c Details

SPL UNCLASSIFIED SECTION

Rx Only

DESCRIPTION

Each gram of Nystatin Ointment USP contains 100,000 units of nystatin in a white petrolatum base.

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 of undetermined structural formula 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 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.

ADVERSE REACTIONS

Nystatin is virtually nontoxic 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 the affected areas twice a day or as indicated until healing is complete. The ointment does not stain the skin or mucous membranes and it provides a simple, convenient means of treatment.

HOW SUPPLIED

Nystatin Ointment USP 100,000 units/g

15 g tube (0.53 oz)

Store at controlled room temperature 15°-30°C (59°-86°F). Do not freeze.

Distributed by:

Actavis Pharma, Inc.

Parsippany, NJ 07054 USA

FORM NO. 0166

Rev. 10/19

VC2752

Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320

Package/Label Display Panel

INGREDIENTS AND APPEARANCE

NYSTATIN

nystatin ointment

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:63187-464(NDC:0472-0166)
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
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63187-464-15	1 in 1 CARTON	01/01/2019
1		15 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	ANDA062840	09/03/2002

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(63187-464) , RELABEL(63187-464)

Revised: 10/2022

Document Id: 2aeb648a-b45f-4dd7-93f0-610d7490b464

Set id: d7d04c02-d07d-4382-8f93-5c0c3e68790c

Version: 5

Effective Time: 20221001