NYSTATIN NYSTATIN LEADING PHARMA, LLC FDA Approved Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei . The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.1. Structural formula: Nystatin topical powder is for dermatologic use. Nystatin topical powder contains 100,000 nystatin units per gram dispersed in talc. Chemical-structure

NYSTATIN

Generic: NYSTATIN
Mfr: LEADING PHARMA, LLC FDA Rx Only
FunFoxMeds bottle
Substance Nystatin
Route
TOPICAL
Applications
ANDA208838
Product NDC
69315-0306-00 69315-0306-15 69315-0306-30 69315-0306-60
Package NDC
69315-306-15 69315-306-30 69315-306-60

Drug Facts

Composition & Profile

Strengths
100000 unit 15 g 30 g 60 g
Treats Conditions
Indications And Usage Nystatin Topical Powder Is Indicated In The Treatment Of Cutaneous Or Mucocutaneous Mycotic Infections Caused By Candida Albicans And Other Susceptible Candida Species Nystatin Topical Powder Is Not Indicated For Systemic Oral Intravaginal Or Ophthalmic Use

Identifiers & Packaging

Container Type BOTTLE
NDC 69315-0306-00
All Product Codes
69315-0306-00 69315-0306-15 69315-0306-30 69315-0306-60
UPC
0369315306307 0369315306604
UNII
BDF1O1C72E
SPL Set IDs
089e6444-2bd1-443e-acf0-dfeaa69faef9
Packaging

HOW SUPPLIED Nystatin topical powder is supplied as 100,000 units nystatin per gram in plastic squeeze bottles: 15g (NDC 69315-306-15) 30g (NDC 69315-306-30) 60g (NDC 69315-306-60) STORAGE Store at 20°C to 25°C (68°F to 77°F)[see USP Controlled Room Temperature]; avoid excessive heat (40°C/104°F). Keep tightly closed. Manufactured for: Leading Pharma LLC, Fairfield, NJ 07004 Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02301 R1-01/20; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container-100000unit15gm Container-100000unit30gm Container-100000unit60gm

Package Descriptions
  • HOW SUPPLIED Nystatin topical powder is supplied as 100,000 units nystatin per gram in plastic squeeze bottles: 15g (NDC 69315-306-15) 30g (NDC 69315-306-30) 60g (NDC 69315-306-60) STORAGE Store at 20°C to 25°C (68°F to 77°F)[see USP Controlled Room Temperature]; avoid excessive heat (40°C/104°F). Keep tightly closed. Manufactured for: Leading Pharma LLC, Fairfield, NJ 07004 Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02301 R1-01/20
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container-100000unit15gm Container-100000unit30gm Container-100000unit60gm
Overview

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei . The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.1. Structural formula: Nystatin topical powder is for dermatologic use. Nystatin topical powder contains 100,000 nystatin units per gram dispersed in talc. Chemical-structure

Indications & Usage

Nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species . Nystatin topical powder is not indicated for systemic, oral, intravaginal or ophthalmic use.

Dosage & Administration

Not available

Warnings & Precautions
No warnings available yet.
Contraindications

Nystatin topical powder is contraindicated in patients with a history of hypersensitivity to any of its components.

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Additional Information

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