Nystatin Oral Suspension 100000 [USP'U]/mL
NYSTATIN · SUSPENSION · Xttrium Laboratories, Inc.
Nystatin oral suspension is a prescription antifungal medication used to treat fungal infections in the mouth and throat. It works by stopping the growth of fungus and is taken by mouth as a liquid.
Key Facts
- Brand Name
- Nystatin Oral Suspension
- Generic Name
- NYSTATIN
- NDC Code (Product)
0116-4026- Manufacturer
- Xttrium Laboratories, Inc.
- Strength
- 100000 [USP'U]/mL
- Dosage Form
- SUSPENSION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA062512
- Drug Class
- Polyene Antifungal [EPC]
- Marketing Start
- 02/06/2026
Recall History
Pharmaceutical Associates Inc
Subpotent: Out of specification for assay at the 12-month time point.
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.
VistaPharm, Inc.
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
VistaPharm, Inc.
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Akorn, Inc.
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
VistaPharm, Inc.
Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
PAI Holdings, LLC. dba Pharmaceutical Associates Inc
SubPotent Drug: Low out-of-specification results for assay testing.
VistaPharm, Inc.
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
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: 4-6 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. To report SUSPECTED ADVERSE REACTIONS, contact Xttrium Laboratories, Inc. at 1-800-587-3721 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Nystatin Oral Suspension used for?
Nystatin oral suspension is a prescription antifungal medication used to treat fungal infections in the mouth and throat. It works by stopping the growth of fungus and is taken by mouth as a liquid.
Is Nystatin Oral Suspension a controlled substance?
Nystatin Oral Suspension is not classified as a controlled substance by the DEA.
What is the generic name for Nystatin Oral Suspension?
The generic name for Nystatin Oral Suspension is NYSTATIN. There are 11 other brand versions of NYSTATIN.
What is the NDC code for Nystatin Oral Suspension 100000 [USP'U]/mL?
The NDC (National Drug Code) for Nystatin Oral Suspension 100000 [USP'U]/mL is 0116-4026, listed by Xttrium Laboratories, Inc..
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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)