Nystatin 100000 [USP'U]/g
Nystatin · CREAM · Padagis Israel Pharmaceuticals Ltd
Nystatin cream is a prescription antifungal medication applied directly to the skin to treat fungal infections caused by Candida and other susceptible fungi. It works by disrupting the fungal cell membrane to stop the infection from spreading.
Key Facts
- Brand Name
- Nystatin
- Generic Name
- Nystatin
- NDC Code (Product)
45802-059- Manufacturer
- Padagis Israel Pharmaceuticals Ltd
- Strength
- 100000 [USP'U]/g
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA062225
- Drug Class
- Polyene Antifungal [EPC]
- Marketing Start
- 09/21/2006
Recall History
Fagron, Inc
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Pharmaceutical Associates Inc
Subpotent: Out of specification for assay at the 12-month time point.
Dr. Reddy's Laboratories, Inc.
Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
X-Gen Pharmaceuticals Inc.
Presence of Foreign Substance: potential presence of plastic particles.
Fagron, Inc
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Crown Laboratories
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Taro Pharmaceuticals U.S.A., Inc.
Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Subpotent drug: Out of specification for assay at the 15-month test interval.
VistaPharm, Inc.
Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
Pharmaceutical Associates Inc
Resuspension problems: Out of specification for appearance and resuspendability.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
Dosage & Administration
DOSAGE AND ADMINISTRATION INFANTS 2 mL (200,000 units) four times daily (in infants and young children, use dropper to place one-half of dose in each side of mouth and avoid feeding for 5 to 10 minutes). NOTE: Limited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective. CHILDREN AND ADULTS 4 to 6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). The preparation should be retained in the mouth as long as possible before swallowing. Continue treatment for at least 48 hours after perioral symptoms have disappeared and cultures demonstrate eradication of Candida albicans .
Contraindications
CONTRAINDICATIONS The preparation is contraindicated in patients with a history of hypersensitivity to any of its components.
Adverse Reactions
ADVERSE REACTIONS Nystatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported. (See PRECAUTIONS: General ). Gastrointestinal: Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances. Dermatologic: Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely. Other: Tachycardia, bronchospasm, facial swelling, and non-specific myalgia have also been rarely reported.
Frequently Asked Questions
What is Nystatin used for?
Nystatin cream is a prescription antifungal medication applied directly to the skin to treat fungal infections caused by Candida and other susceptible fungi. It works by disrupting the fungal cell membrane to stop the infection from spreading.
Is Nystatin a controlled substance?
Nystatin is not classified as a controlled substance by the DEA.
What is the generic name for Nystatin?
The generic name for Nystatin is Nystatin. There are 9 other brand versions of Nystatin.
What is the NDC code for Nystatin 100000 [USP'U]/g?
The NDC (National Drug Code) for Nystatin 100000 [USP'U]/g is 45802-059, listed by Padagis Israel Pharmaceuticals Ltd.
Other Nystatin Brands
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)