NYSTATIN 100000 [USP'U]/mL Suspension, 473 mL — NDC 64950-372-47 (Billing 64950-0372-47)
This is a package of 473 mL of NYSTATIN 100000 [USP'U]/mL Suspension from Genus Lifesciences Inc., marketed since Mar 2026 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.
NDC database record
One package, one record: these facts belong to NDC 64950-372-47 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 64950 labeler · 372 product · 47 package
- Package marketed since
- Mar 24, 2026
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Billing quantity
- 473 mL per package
- Barcode (UPC)
- 0364950372069
- FDA record last changed
- Jul 24, 2026
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
- 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 5, 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 5, 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 | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| 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 · refreshed Oct 5, 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 |
|---|---|---|---|---|---|---|
| 64950-0372-06 64950-372-06 | 60 mL in 1 BOTTLE, DROPPER | — | — | 2026-05-11 | — | Active |
| 64950-0372-47 You're viewing this Main listing | 473 mL in 1 BOTTLE | $0.0569 / mL | $26.93 | 2026-03-24 | — | Active |
You're viewing the largest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 64950-0372-06?
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 64950-0372-47 | Genus | 473 ml | $0.057 | AA | Availability likely | — |
| Nystatin 100000 [USP'U]/mL 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 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 Oct 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 Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 5, 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.
🧪 Avoiding an ingredient? See Nystatin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 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.
-
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.
-
UNII BUC5I9595W
A natural flavoring derived from cherry fruit that gives the medicine its cherry taste. It helps mask bitter drug flavors and makes the medication more pleasant to take.
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UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
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UNII L6Q8K29L05
A sweet-smelling organic compound used in medicines as a flavor enhancer and fragrance agent. It strengthens or improves the taste and aroma of liquid or solid formulations.
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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 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 FV98Z8GITP
A natural flavoring from mint plants. It's added to medicines to mask bitter tastes and improve how the medicine tastes, making it easier to take.
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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 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
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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.
12 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 5, 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
More NDCs from Genus Lifesciences Inc. labeler code 64950
- Clemastine Fumarate .67 mg/5mL Syrup NDC 64950-324-12
- Hydrocodone Bitartrate and Acetaminophen 7.5 mg/15mL; 325 mg/15mL Solution NDC 64950-343-11
- Metoclopramide 5 mg/5mL Solution NDC 64950-344-16
- Promethazine Hydrochloride and Phenylephrine 6.25 mg/5mL; 5 mg/5mL Solution NDC 64950-345-16
- Oxycodone Hydrochloride 5 mg/5mL Solution NDC 64950-354-10
- Hydrocodone Bitartrate and Homatropine Methylbromide 5 mg/5mL; 1.5 mg/5mL Solution NDC 64950-371-47
- Hydrocodone Bitartrate and Acetaminophen 7.5 mg/15mL; 325 mg/15mL Solution NDC 64950-373-04
- Acetaminophen and Codeine Phosphate 120 mg/5mL; 12 mg/5mL Solution NDC 64950-374-04
- Silver Nitrate .005 g/mL Solution NDC 64950-378-96
- Ciprofloxacin Otic .5 mg/.25mL Solution/ Drops NDC 64950-381-14
- Dorzolamide Hydrochloride and Timolol Maleate 20 mg/mL; 5 mg/mL Solution NDC 64950-390-60
- Phenazopyridine Hydrochloride 100 mg Tablet NDC 64950-550-01
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 candidiasis in the oral cavity.
⏱️ Dosage and 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 reported.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Category C Animal reproduction studies have not been conducted with nystatin oral suspension. It is also not known whether nystatin oral suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin oral suspension should be given to a pregnant woman only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use See DOSAGE AND ADMINISTRATION .
🆘 Overdosage ▾
OVERDOSAGE Oral doses of nystatin in excess of five million units daily have caused nausea and gastrointestinal upset. There have been no reports of serious toxic effects or superinfections (See CLINICAL PHARMACOLOGY, Pharmacokinetics ).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Pharmacokinetics Gastrointestinal absorption of nystatin is insignificant. Most orally administered nystatin is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of nystatin may occasionally occur.
Microbiology Nystatin is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. Candida albicans demonstrates no significant resistance to nystatin in vitro on repeated subculture in increasing levels of nystatin; other Candida species become quite resistant. Generally, resistance does not develop in vivo .
Nystatin acts by binding to sterols in the cell membrane of susceptible Candida species with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.
📦 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 60 mL bottles with calibrated dropper and 473 mL bottles. It is supplied as follows: NDC 64950-372-06 60 mL NDC 64950-372-47 473 mL Storage Store at 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30°C (59°C to 86°F) [See USP Controlled Room Temperature]; avoid freezing.
📦 Storage and Handling ▾
Storage Store at 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30°C (59°C to 86°F) [See USP Controlled Room Temperature]; avoid freezing.
📋 Description ▾
DESCRIPTION Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei . Structural formula: C 47 H 75 NO 17 MW = 926.13 Nystatin Oral Suspension is a cherry-mint flavored suspension for oral administration. It contains 100,000 USP Nystatin Units per mL.
Inactive ingredients: alcohol ( 1% v/v), carboxymethylcellulose sodium, flavor, glycerin, methylparaben, propylparaben, purified water, saccharin sodium, sodium citrate, and sucrose (50% w/v). May also contain citric acid for pH adjustment. Chemical Structure
⚠️ Precautions ▾
PRECAUTIONS General This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use. Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic potential.
There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females. Pregnancy Teratogenic Effects Category C Animal reproduction studies have not been conducted with nystatin oral suspension. It is also not known whether nystatin oral suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Nystatin oral suspension should be given to a pregnant woman only if clearly needed. 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 .
🍼 Nursing Mothers ▾
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.
🧬 Pharmacokinetics ▾
Pharmacokinetics Gastrointestinal absorption of nystatin is insignificant. Most orally administered nystatin is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of nystatin may occasionally occur.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 64950-372-47 Nystatin Oral Suspension, USP 100,000 units per mL SHAKE WELL BEFORE USING EACH mL CONTAINS: 100,000 USP Nystatin Units in a vehicle containing 50% sucrose. Not more than 1% alcohol by volume. USUAL DOSAGE FOR INFANTS: 2 mL (200,000 units) four times daily (1 mL in each side of mouth).
USUAL DOSAGE FOR CHILDREN AND ADULTS: See package insert. DISPENSE in tight, light-resistant container as defined in the USP. STORE at 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]; avoid freezing.
1 Pint (473 mL) Rx Only Genus™ Lifesciences Inc. PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label NDC 64950-372-06 Nystatin Oral Suspension, USP 100,000 units per mL SHAKE WELL BEFORE USING 60 mL Rx Only Genus™ Lifesciences Inc. PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label