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NYSTATIN 100000 [USP'U]/mL Suspension, 473 mL — NDC 69315-504-47 (Billing 69315-0504-47)
This is a package of 473 mL of NYSTATIN 100000 [USP'U]/mL Suspension from Leading Pharma, LLC, marketed since Dec 2022 and currently FDA-listed; retail pharmacies pay about $0.0569 per mL (NADAC). It is the main listing for this product, which comes in 2 package sizes.
Other active recalls for Nystatin (different manufacturers) — 1 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 009537
- GCN: 42440
- GPI-14 (Medi-Span): 88100010001805
- HICL (First Databank): 004129
- AHFS class code: 08:14.28.00
- RxCUI (RxNorm): 312055
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Polyene Antifungal class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Nystatin is used to treat fungal infections of the inside of the mouth and lining of the stomach and intestines. Nystatin is in a class of antifungal medications called polyenes. It works by stopping the growth of fungi that cause infection.
Read the full MedlinePlus article ↗- It treats Candida yeast infections. Creams, ointment and powder are for the skin. The liquid is for the mouth. Tablets are for the digestive tract lining.
- Place half the dose in each side of your mouth and keep it there as long as you can before swallowing. For babies, use the dropper and avoid feeding for 5 to 10 minutes. Keep going...
- How do I use the liquid for a mouth infection?
- Cream and ointment are usually applied twice a day. Powders are used two or three times a day. Keep using it until the area has healed, and follow your prescriber’s directions.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Nystatin — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.057 | $26.91 / 473 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.0845 | $39.97 / 473 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.1064 | $50.33 / 473 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 69315-0504-47 You're viewing this Main listing | 473 mL in 1 BOTTLE | $0.0569 / mL | $26.93 | 2022-12-05 | — | Active |
| 69315-0504-60 69315-504-60 | 1 BOTTLE in 1 PACKAGE / 60 mL in 1 BOTTLE | $0.1400 / mL | $8.40 | 2022-12-05 | — | Active |
This pack has the lowest per-mL cost of the 2 priced pack sizes ($0.0569 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 71% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of NYSTATIN 100000 [USP'U]/mL Suspension?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Nystatin 100000 [USP'U]/mLthis 69315-0504-47 | Leading | 473 ml | $0.057 | AA | Availability likely | — |
| Nystatin 100000 U/mL 85742-0013-11 | Kanchan | 473 ml | $0.057 | AA | Availability likely | — |
| Nystatin 100000 [USP'U]/mL 00121-1045-16 | PAI | 473 ml | $0.058 | AA | Discontinued | +3% |
| Nystatin 100000 U/mL 62135-0813-46 | Chartwell | 60 ml | $0.140 | AA | Availability likely | +146% |
| Nystatin 100000 [USP'U]/mL 00121-0868-00 | PAI | 10 cups | $0.176 | AA | FDA listed | +208% |
| Nystatin 100000 [USP'U]/mL 00904-7276-70 | Major | 10 cups | $0.176 | AA | FDA listed | +208% |
| Nystatin 100000 [USP'U]/mL 60687-0800-17 | American | 10 cups | $0.176 | AA | FDA listed | +208% |
| Nystatin Oral Suspension 100000 [USP'U]/mL 00116-4026-11 | Xttrium | 10 cups | — | AA | FDA listed | — |
| Nystatin 100000 [USP'U]/mL 00121-0810-02 | Pharmaceutical | 60 ml | — | AA | FDA listed | — |
| Nystatin 100000 [USP'U]/mL 00121-4810-00 | Pharmaceutical | 10 cups | — | AA | FDA listed | — |
| Nystatin 100000 [USP'U]/mL 17856-0508-01 | ATLANTIC | 72 cups | — | AA | FDA listed | — |
| Nystatin 100000 [USP'U]/mL 17856-1045-01 | ATLANTIC | 72 cups | — | AA | Discontinued | — |
| Nystatin 100000 [USP'U]/mL 50090-1740-00 | A-S | 60 ml | — | AA | FDA listed | — |
| Nystatin 100000 [USP'U]/mL 50090-5315-00 | A-S | 60 ml | — | AA | FDA listed | — |
| Nystatin 100000 [USP'U]/mL 51672-4117-00 | Taro | 3785 ml | — | — | Discontinued | — |
| Nystatin 100000 [USP'U]/mL 55154-4314-05 | Cardinal | 5 cups | — | AA | FDA listed | — |
| Nystatin 100000 [USP'U]/mL 55154-5788-05 | Cardinal | 5 cups | — | AA | FDA listed | — |
| Nystatin 100000 [USP'U]/mL 63629-8520-01 | Bryant | 473 ml | — | AA | FDA listed | — |
| Nystatin 100000 [USP'U]/mL 64950-0372-06 | Genus | 60 ml | — | AA | FDA listed | — |
| Nystatin 100000 [USP'U]/mL 68071-3543-06 | NuCare | 1 bottle | — | AA | FDA listed | — |
| Nystatin 100000 [USP'U]/mL 68788-8561-04 | Preferred | 473 ml | — | AA | FDA listed | — |
| Nystatin 100000 U/mL 68999-0813-24 | Chartwell | 10 cups | — | AA | FDA listed | — |
| Nystatin 100000 U/mL 72162-2645-02 | Bryant | 473 ml | — | AA | FDA listed | — |
| Nystatin 100000 U/mL 81033-0015-01 | Kesin | 100 cups | — | AA | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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UNII K679OBS311
Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
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UNII SR60A3XG0F
Cinnamal is a fragrant organic compound derived from cinnamon oil. It's used in medicines as a flavoring agent and fragrance to make the product taste or smell more pleasant.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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UNII AV092KU4JH
A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.
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UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
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UNII SB8ZUX40TY
Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 22ADO53M6F
A mineral salt derived from phosphoric acid, used as a buffer to maintain the pH balance of the medication and help stabilize the active ingredients.
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UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
13 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Nystatin oral suspension is indicated for the treatment of infections of the oral cavity caused by Candida albicans.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Infants: 2 mL (200,000 units) four times daily (1 mL in each side of mouth). Pediatric patients and adults: 4 to 6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). NOTE: Limited clinical studies in neonates, including premature and low-birth weight neonates, indicate that 1 mL (100,000 units) four times daily is effective.
Local treatment should be continued at least 48 hours after perioral symptoms have disappeared and/or cultures returned to normal. It is recommended that the drug be retained in the mouth as long as possible before swallowing.
⛔ Contraindications ▾
CONTRAINDICATIONS Nystatin is contraindicated in patients with a history of hypersensitivity to nystatin or any of the suspension components.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 OR LEADING PHARMA, LLC AT 1-844-740-7500 or www.fda.gov/medwatch. Gastrointestinal symptoms including diarrhea, gastrointestinal distress, nausea, vomiting and burning of the mouth have been reported. Hypersensitivity reactions including rash, pruritus, and anaphylactoid reaction have also been reported.
🆘 Overdosage ▾
OVERDOSAGE Oral doses of nystatin in excess of five million units daily have caused nausea and gastrointestinal upset.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Nystatin acts by binding to sterols in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin is absorbed very sparingly following oral administration, with no detectable blood levels when given in the recommended doses.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Nystatin Oral Suspension, USP, 100,000 USP Nystatin Units per mL, is available as a cherry-mint flavored, light creamy yellow, ready-to-use suspension, in the following sizes: 60 mL bottles with a child-resistant cap and calibrated dropper. 1 Pint (473 mL) bottles with a child-resistant cap. Storage This package is child-resistant.
Keep out of reach of children. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing NDC for 60 ml: 69315-504-60 NDC for 473 ml: 69315-504-47 Rx Only
📋 Description ▾
DESCRIPTION Nystatin is obtained from Streptomyces noursei. It is known to be a mixture, but the composition has not been completely elucidated. Nystatin A is closely related to amphotericin B.
Each is a macro-cyclic lactone containing a ketal ring, an all-trans polyene system, and a mycosamine (3-amino-3-deoxyrhamose) moiety. Structural formula: Nystatin Oral Suspension, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), sucrose 50% w/v, peppermint oil, NF, cinnamaldehyde, disodium hydrogen phosphate, USP, carboxymethylcellulose sodium, USP, glycerin, USP, saccharin sodium, USP, cherry flavor, methylparaben, NF, propylparaben, NF and purified water, USP.
May also contain sodium hydroxide, NF and/ or hydrochloric acid, NF for pH adjustment. chemstructure
⚠️ Precautions ▾
PRECAUTIONS General Discontinue treatment with nystatin if sensitization or irritation is reported during use. Nystatin is not effective in the treatment of systemic mycoses since it is not significantly absorbed from the gastrointestinal tract. Information for the Patient Patient should be advised to retain nystatin in the mouth as long as possible and to continue its use for at least 2 days after symptoms have subsided.
There should be no interruption or discontinuation of the medication until the prescribed course of treatment is completed, even though symptomatic relief may occur within a few days. If symptoms of local irritation develop, the physician should be notified immediately. Laboratory Tests If there is a lack of therapeutic response, appropriate microbiological studies (e .g., KOH smears and/or cultures) should be repeated to confirm the diagnosis of candidiasis and rule out other pathogens before instituting another course of therapy.
Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. In mice exposed to nystatin 50 mg/kg by injection, an increased incidence of chromosomal aberrations, consisting primarily of chromatid breaks, was observed in bone marrow cells. However, there have been no studies to determine the mutagenicity of orally-administered nystatin or its effects on fertility in males or females.
Pregnancy : Teratogenic Effects Teratogenicity studies have not been conducted with nystatin. It is also not known whether nystatin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin should be given to a pregnant woman only if clearly needed.
Nonteratogenic Effects In one rat reproductive study, nystatin was administered orally to pregnant rats in single doses of 100, 500, or 3000 mg/kg on the ninth day of gestation, or as multiple doses of 500 mg/kg/day on gestation days 1-20, 1-4, 7-10, 11-14, or 15-18. It was found that nystatin had a slight abortive effect when used during the whole period of pregnancy. No abnormalities were seen in surviving fetuses.
Although no adverse effects or complications have been attributed to the use of intra-vaginal nystatin in neonates born to women treated during pregnancy, no similar studies evaluating complications of oral nystatin have been conducted. Nursing Mothers It is not known whether nystatin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nystatin is administered to a nursing woman.
Pediatric Use See DOSAGE AND ADMINISTRATION section for pediatric dosing recommendations.
📄 Package Label / Principal Display Panel ▾
containerlabel-60ml cartonlabel-60ml containerlabel-473ml