Drug Catalog - Product Detail
NYSTATIN TOPICAL POWDER (NYSTOP) PWD 100MU 30GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00574-2008-30 | PADAGIS | 30 | 100000UNIT/GM | POWDER |
PACKAGE FILES
Generic Name
NYSTATIN
Substance Name
NYSTATIN
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA064118
Description
DESCRIPTION Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. The molecular formula for Nystatin is C 47 H 75 NO 17 . The molecular weight of Nystatin is 926.1. Structural formula: Nystatin Topical Powder USP is for dermatologic use. Nystatin Topical Powder USP contains 100,000 USP nystatin units per gram dispersed in talc. Structural Formula
How Supplied
HOW SUPPLIED Nystop ® Nystatin Topical Powder USP is supplied as 100,000 units nystatin per gram in 15 g, 30 g and 60 g plastic squeeze bottles. (NDC 0574-2008-15) (NDC 0574-2008-30) (NDC 0574-2008-02) STORAGE Store at controlled room temperature 15°-30°C (59°-86°F); avoid excessive heat (40°C; 104°F). Manufactured By Padagis Minneapolis, MN 55427 www.padagis.com Rev 01-23
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. This preparation is not indicated for systemic, oral, intravaginal or ophthalmic use.
Dosage and Administration
DOSAGE AND ADMINISTRATION Very moist lesions are best treated with the topical dusting powder. Adults and Pediatric Patients (Neonates and Older): Apply to candidal lesions two or three times daily until healing is complete. For fungal infection of the feet caused by Candida species, the powder should be dusted on the feet, as well as, in all foot wear.