RVP

Drug Catalog - Product Detail

NYSTATIN TOPICAL POWDER 100MU 60GM

NDC Mfr Size Str Form
69315-0306-60 LEADING PHARMA 60 100000UNIT/GM POWDER
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PACKAGE FILES

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Generic Name
NYSTATIN
Substance Name
NYSTATIN
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA208838
Description
DESCRIPTION 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
How Supplied
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
Indications & Usage
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.
Dosage and Administration