Drugplain

Nystatin Topical Powder 100000 U/g

Nystatin Topical Powder · POWDER · Epic Pharma, LLC

1 Recall on Record
Plain English

Nystatin Topical Powder is a powder containing nystatin topical powder at 100000 U/g, taken topical. Manufactured by Epic Pharma, LLC.

Key Facts

Brand Name
Nystatin Topical Powder
Generic Name
Nystatin Topical Powder
NDC Code (Product)
42806-185
Manufacturer
Epic Pharma, LLC
Strength
100000 U/g
Dosage Form
POWDER
Route
TOPICAL
Marketing Status
Application #
ANDA210532
Drug Class
Polyene Antifungal [EPC]
Marketing Start
04/14/2023

Recall History

1 Recall on Record
Class II05/17/2017

X-Gen Pharmaceuticals Inc.

Presence of Foreign Substance: potential presence of plastic particles.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

confusional state2 reports
sepsis2 reports
thrombocytopenia2 reports
anaemia1 reports
atrial fibrillation1 reports
blood bilirubin increased1 reports
blood creatinine increased1 reports
bone marrow disorder1 reports
cardiac failure1 reports
coagulopathy1 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. Nystatin topical powder 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 powder 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 Nystatin Topical Powder used for?

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

Is Nystatin Topical Powder a controlled substance?

Nystatin Topical Powder is not classified as a controlled substance by the DEA.

What is the generic name for Nystatin Topical Powder?

The generic name for Nystatin Topical Powder is Nystatin Topical Powder. There are 1 other brand versions of Nystatin Topical Powder.

What is the NDC code for Nystatin Topical Powder 100000 U/g?

The NDC (National Drug Code) for Nystatin Topical Powder 100000 U/g is 42806-185, listed by Epic Pharma, LLC.

Product NDC

42806-185

Package NDC

42806-185-15

Other Nystatin Topical Powder Dosages

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

Data from openFDA · Public domain (CC0 1.0)