Nystop 100000 [USP'U]/g

Nystatin · POWDER · Padagis US LLC

No Recall History

Plain English

Nystop is a powder containing nystatin at 100000 [USP'U]/g, taken topical. Manufactured by Padagis US LLC.

Key Facts

Brand Name: Nystop
Generic Name: Nystatin
NDC Code (Product): 0574-2008
Manufacturer: Padagis US LLC
Strength: 100000 [USP'U]/g
Dosage Form: POWDER
Route: TOPICAL
Marketing Status
Application #: ANDA064118
Drug Class: Polyene Antifungal [EPC]
Marketing Start: 08/16/1996

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

nausea2,005 reports

fatigue1,806 reports

diarrhoea1,800 reports

pneumonia1,645 reports

dyspnoea1,498 reports

off label use1,421 reports

vomiting1,365 reports

pain1,258 reports

drug ineffective1,245 reports

death1,191 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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 & 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.

Contraindications

CONTRAINDICATIONS Nystatin Topical Powder is contraindicated in patients with a history of hypersensitivity to any of its components.

Adverse Reactions

ADVERSE REACTIONS The frequency of adverse events reported in patients using nystatin topical preparations is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application. (See PRECAUTIONS: General .)

Frequently Asked Questions

What is Nystop used for?

Nystop contains Nystatin. It is a powder taken topical. Consult your doctor for specific uses.

Is Nystop a controlled substance?

Nystop is not classified as a controlled substance by the DEA.

What is the generic name for Nystop?

The generic name for Nystop is Nystatin. There are 12 other brand versions of Nystatin.

What is the NDC code for Nystop 100000 [USP'U]/g?

The NDC (National Drug Code) for Nystop 100000 [USP'U]/g is 0574-2008, listed by Padagis US LLC.

Product NDC

0574-2008

Package NDC

0574-2008-02

Other Nystatin Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)